Dr. Chino talks with Dr. Erin Roesch and patient advocate Julia Maues about pregnancy associated cancer with a focus on breast cancer, the most common cancer diagnosed during pregnancy. This discussion is based off an JCO OP review article published in late 2024 called "Multidisciplinary Management of Pregnancy-Associated Breast Cancer."

Dr. Fumiko Chino:
Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

The incidence of early-onset cancer—new cancers in adults under the age of 50—is rising by 1% to 2% annually. Young women appear to be at particular risk, with cancer incident rates over 80% higher than similarly aged male counterparts. Collectively, that means that more patients are being diagnosed with cancer during their childbearing years. Pregnancy-associated cancer occurs in 1 in every 1,000 to 3,000 pregnancies and refers to cancer that is diagnosed either during pregnancy or within 1 year of delivery.

On today's episode, we'll be talking about pregnancy-associated cancer, with a focus on breast cancer, as it is the most common cancer diagnosed during pregnancy. This discussion will be based off of a JCO OP article published in late 2024 called "Multidisciplinary Management of Pregnancy-Associated Breast Cancer."

I'm excited to welcome both the first author of this review article and a patient advocate to the podcast today. They are both passionate about improving outcomes for people with breast cancer.

Dr. Erin Roesch is an assistant professor of medicine at Cleveland Clinic Lerner College of Medicine and a medical oncologist at the Cleveland Clinic Taussig Cancer Institute specializing in the treatment of breast cancer. She is involved in clinical trials research, and some of her specific interests include the care of young women diagnosed with breast cancer, fertility in oncology patients, and women's health and survivorship.

Julia Maues is a patient advocate working with researchers, clinicians, and other stakeholders to ensure research is patient-centered, innovative, accessible, and inclusive. She was working as an economist when she was diagnosed with breast cancer while pregnant in 2013. After delivering her son, she found out that cancer had already spread to her bones, liver, and brain. Julia co-founded GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization that connects and fosters collaborations between researchers and patient advocates. She is also active within the Metastatic Breast Cancer Alliance and helped write the ASCO guideline for brain metastasis.

Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the podcast today.

Erin and Julia, it's really wonderful to speak to you today.

Dr. Erin Roesch:
Thank you. I appreciate the opportunity to be here and discuss this really important topic.

Julia Maues:
Thank you for having me. It's very important to include the patient voice on this topic, and unfortunately, I have a personal experience with this.

Dr. Fumiko Chino:
Our topic today is pregnancy-associated cancer. Erin, can you give us a quick overview of the background for pregnancy and breast cancer? I know in the recent era, breast cancer rates for those under the age of 50 have been rising faster than for other cancers, up to 1.4% per year since the mid-2000s. I'd always thought that pregnancy-associated cancer was pretty rare, and so I was really shocked to read in your paper that for women younger than 35, 1 in 6 with breast cancer are diagnosed around pregnancy.

Dr. Erin Roesch:
Yes. So, a cancer diagnosis during pregnancy is rare, with the incidence, as mentioned, of about 1 in 3,000 pregnancies, with pregnancy-associated breast cancer, or PABC, representing about 7% of all breast cancers diagnosed per year. Among women under the age of 45, PABC accounts for roughly about 2.5% to just over 6% of breast cancer cases. And for women less than 35 years, this rises to about 15.5%.

Studies have shown a rise in PABC in recent years, and this is anticipated to continue with the trend of delayed age at childbearing. In regards to the pathophysiology of pregnancy-associated breast cancer, various hypotheses have been proposed to kind of try and shed more light on how this occurs and the driving factors for PABC. So these include hormonal changes that occur during pregnancy and lactation, immunologic changes that can lead to the immune tolerance of tumor cells, and also breast tissue involution that occurs after delivery and breastfeeding, which can lead to a proinflammatory state.

In regards to risk factors, these include a positive family history, which is one of the strongest risk factors for breast cancer development, this includes pregnancy-associated breast cancer, pathogenic germline mutations—specifically BRCA1 or 2—and older maternal age at time of birth. We also know that breastfeeding has been shown to have a protective effect against breast cancer development.

Dr. Fumiko Chino:
So what I'm hearing from you is that just given the incidence rising in younger people and also delayed pregnancy, that this is really something that we're unfortunately going to be facing more and more frequently in our clinics and something that patients unfortunately will find that they have to face as well.

Dr. Erin Roesch:
Yes, yes, I think that's accurate. And just again, I think points to the importance of awareness of this particular topic.

Dr. Fumiko Chino:
Now, Julia, your lived experience in this space is really invaluable. Do you mind sharing it with us?

Julia Maues:
Yeah, of course. I was pregnant at 29, and I found a lump in my breast. I had an excellent OB-GYN and team, and they took it seriously. I think she wanted to watch it for a few weeks, but as soon as it didn't go away, she ordered an ultrasound, and that turned into a biopsy, and that turned into a cancer diagnosis.

I lived near a comprehensive cancer center. I had multidisciplinary care, really excellent team, and was treated with chemotherapy during the pregnancy, which was very surprising to me and hard to accept. But they did provide me with a lot of evidence that that is the best treatment for both my baby and me. And so I did four cycles of Adriamycin-Cytoxan during the pregnancy and delivered my son at 37 weeks. He was healthy and full of hair, even though I was bald. That was very important, I think, for many reasons, but it showed visually that the placenta did its job and he was protected.

After he was born, I could do scans that I couldn't do while pregnant. I had a lot of back pain and things that were thought to be pregnancy-related, or maybe they knew, and they just didn't go there because it really wouldn't have made a difference at that point, like, the treatment couldn't be any different. But I did that scan and found out that it was metastatic, and that changed the treatment that I did after the pregnancy, and instead of eventually surgery, I just stayed on systemic therapy for that long. And spoiler alert, this is 12 years later. That baby is in sixth grade and thriving. And I am very grateful for the privilege that I have to have received such excellent care and have access to the treatments that I have had, and also the luck to have had good response to treatments.

Dr. Fumiko Chino:
I love how you've taken your story and the successes, but also the horror and the terror, and really used it to galvanize your life in a mission to try to improve patient care for others. So I've always really thought that was phenomenal in terms of your mission and your drive.

Julia Maues:
Thank you. I'm very, very happy that it helps other people, but selfishly, it helps me to deal with my own difficult experience, and it's been a way to make something good out of this.

Dr. Fumiko Chino:
I feel very aligned with you on that in terms of my own personal story as a caregiver. It's one of the reasons why I became a physician. So I feel like you and I have a common touchstone there. And I think so many people in medicine and so many patient advocates are really trying to give back into a system to try to improve it for all because of either the ways that it helped them or the ways that they thought that it could be doing better. So thank you for sharing that with us.

Now, Julia had mentioned that the staging scans were delayed until after delivery due to some appropriate safety concerns. And I certainly know that those diagnosed during pregnancy often have diagnostic delays. Erin, do you mind discussing what delays may occur in pregnancy-associated breast cancer and if there are any solutions to improve those delays?

Dr. Erin Roesch:
Sure. And I'd like to echo and certainly, you know, thank Julia for sharing her story. And I think as an oncologist, we learn so much from our patients, and so it's really, really important for us to understand, to be able to appreciate everything you've gone through. So I just, I really thank you for that.

So in terms of, you know, the delays that we see—and I think, Julia, your story through this really kind of outlines much of what we see in terms of some of these delays and challenges related to the diagnosis and the workup of pregnant women with suspicion of breast cancer. So although the majority, about 80%, of breast cancers or breast masses, rather, detected during pregnancy will be benign, any palpable mass present for a couple of weeks or more in the breast or axillary region should really be clinically investigated, you know, as your doctor did. Additionally, any other breast changes—less common things such as an asymmetry, thickening of the skin, redness of the skin, nipple changes—those things should also be investigated, you know, as they raise clinical suspicion.

Pregnancy-associated breast cancer often remains undetected in pregnant women until later stages due to potentially symptoms being masked by the physiologic breast changes during pregnancy. Studies have shown that a relatively high proportion, you know, over 80%, of pregnancy-associated breast cancers are self-palpated. We know that later stage at presentation and a delay in care can lead to an inferior prognosis or affect someone's prognosis.

So I think in terms of the challenges, in terms from a diagnostic evaluation standpoint, typical imaging modalities that we use for breast cancer, we know some can have harmful effects on a growing fetus. So the evaluation should begin, as Julia mentioned, with an ultrasound. That would be the initial gold-standard diagnostic test. And then subsequently, a mammogram with abdominal shielding can and should be used to provide additional details regarding the breast mass.

In terms of systemic staging, so I think again, as Julia pointed out, the traditional evaluation for metastatic breast cancer typically includes CT scans with IV contrast of the chest, abdomen, pelvis, and a bone scan or a PET scan. However, these imaging tests should be avoided during pregnancy, particularly during the first trimester, due to the harmful exposure of radiation and IV contrast to the fetus.

In regards to some of the solutions, I think from a systemic staging standpoint, alternative imaging can be used. So when indicated or appropriate, things such as a chest x-ray with shielding, an ultrasound of the liver, an MRI of the spine without contrast could also be considered, again, in the appropriate setting. But I think, you know, Julia certainly highlights the challenges that we face from a diagnostic standpoint.

Dr. Fumiko Chino:
Julia, you had said something probably that was the most important, which is that you felt the mass and that your physician actually took it seriously. And I certainly have heard from other patients that when they were pregnant and they felt something, it was sort of just 'pooh-poohed', for lack of a better term, as, you know, normal changes in the breast, and it wasn't followed up to the extent that it should have. Do you have anything to add in terms of delays? I know you are certainly very active in the advocacy community, so I feel like you've probably heard every good and negative story about delays to diagnosis or care.

Julia Maues:
Yeah, unfortunately, we hear these stories all the time. The clogged milk duct, which may be very plausible, but needs to be investigated, right, is not always the case. And unfortunately, anecdotally, and I know you all have been part of evidence on this, women that are Black experience this at a much higher rate. And then we see younger women with doctors that just tell them that, "Women your age don't get breast cancer."

Dr. Fumiko Chino:
Which is patently false, as we know, because the rates of breast cancer in younger women are rising. So I feel like we need to be standing on top of rooftops trying to make sure we're advocating for our patients and educating our colleagues about the early-onset cancer risk.

Julia Maues:
And I'll say one more thing that I think patients also have a wrong understanding of this statistic about pregnancy protecting from breast cancer after menopause. The only thing that translates is 'pregnancy equals lower rate of breast cancer', right? So that is not necessarily the case while you're pregnant or in the short years after the pregnancy. It is a statistic about postmenopausal breast cancer, which won't affect the pregnant person for many years.

Dr. Fumiko Chino:
Julia, this review highlights the role of the multidisciplinary team for optimal management of pregnancy-associated breast cancer. And from the article, it says, "At the time of diagnosis, multidisciplinary teams should be consulted, including breast surgery, plastic reconstructive surgery, medical oncology, radiation oncology, maternal-fetal medicine, genetics, and psychosocial services." Can you speak to who was involved with your care, including what really worked well in this incredibly stressful situation or lessons learned for what could be improved? I know you said you did have the benefit of a comprehensive cancer center and a multidisciplinary team.

Julia Maues:
Yes, absolutely. A team that came from many angles at this problem was very important. I did see a surgical oncologist, a radiation oncologist, a plastic surgeon, the medical oncologist, of course. And then I had two OB-GYNs, my first OB-GYN and a high-risk OB-GYN, and I did see genetic counseling. And I think after those first appointments, the surgeon and the radiation oncologist and the plastic surgeon didn't play a role. They were going to come back into my care after the pregnancy; that was the plan. But the OB-GYN, and especially the high-risk OB-GYN, was very important. And the fact that they were in touch with my medical oncology team and they were complementing each other in terms of medications and what treatment I needed, that was very important.

Dr. Fumiko Chino:
Erin, do you have anything to add in terms of coordinating these large teams? I know that the medical oncologist often works as sort of the quarterback in this scenario for these teams.

Dr. Erin Roesch:
Yes, and that's exactly how I typically describe myself to patients, is kind of as that quarterback. I think that Julia's description certainly highlights the importance of multidisciplinary care, and it's really crucial for pregnancy-associated breast cancer. And it's important to recognize that it's not a one-size-fits-all approach either, and that not all patients' needs might be the exact same. But that being said, it's helpful to have, you know, an algorithm that outlines the general steps, diagnosis, and management of our patients with pregnancy-associated breast cancer. And it's really important—it's an overwhelming time for patients and their families. So it's really, you know, essential to make sure that our patients have knowledge of and access to all of the resources that are available, you know, during their diagnosis, treatment, and in survivorship. I think that again, just stressing that multidisciplinary care from the beginning is really key.

Dr. Fumiko Chino:
That segues nicely into the next topic, which is: I really found the figure in your article to be particularly helpful as a flowchart for decision-making in pregnancy-associated breast cancer. How do you approach shared decision-making, patient autonomy, and informed consent with your patients when faced with some of these really heartbreaking decisions?

Dr. Erin Roesch:
So, you know, just as I said, it's certainly, you know, it's very individualized, but it is very helpful to have a guide that we can follow and that we can also use for educating other providers on what are modalities that are safe during pregnancy, what we have data on, where we're lacking, et cetera. So I think that when I talk with my patients in this type of situation, you know, I think open lines of communication, transparency, super important. And I think recognizing that breast cancer diagnosed during pregnancy often occurs during a time when a woman is figuring out their life plan. They could be finishing school, family planning, you know, career goals, establishing relationships, just to name a few things. So it's helpful to be aware of these things when we're counseling our patients so that we can better really appreciate, understand their goals and, as much as possible, help them achieve their goals while also effectively treating their breast cancer. So I always really, really strive to involve my patients in the decision-making regarding their care, but also advise them that I'm there to provide full support and whatever information that I can to be helpful.

Dr. Fumiko Chino:
I love that thing to highlight—that cancer doesn't define someone's existence, and they were a whole human being before their cancer diagnosis, and they should be a whole human being after their cancer diagnosis. And so making sure that we are talking to a person, not to a cancer diagnosis and a treatment plan. It's an individual on the other side.

Now, Julia, I know that you said that your stage IV diagnosis came after you delivered. I'm sure that there was a shock and horror related to that. Do you have anything to add in terms of the multidisciplinary team or how it pivoted once you got that diagnosis?

Julia Maues:
I completely agree with the 'quarterback' name to the medical oncologist. They definitely have, even today, this role in my life, and I definitely benefited from really wonderful quarterbacks in my years. But I think another very important connection there is being able to connect to other patients with a similar experience. I did - at different times, I was able to connect to people who had just had a baby after treatment during pregnancy, or who had a child that was maybe a little bit older and they were thriving, and just knowing that that was a possibility or a likely possibility for my child, even though I was making him go through these treatments while inside me.

Dr. Fumiko Chino:
Now, pregnant women, human fetuses, and neonates have additional protected status under the federal government that mandates special IRB review. This means that pregnant women are often excluded from research, often without actually clear justification, even when the research really poses minimal risk. Erin, how do we improve the body of evidence to support best care for patients with pregnancy-associated breast cancer, understanding some of these concerns?

Dr. Erin Roesch:
Yes, so I think it is really important to utilize the research means that we do have. So an example of this could include retrospective analyses, you know, looking at registry data. We can really gain important, valuable information this way. Additionally, learning from thought leaders in this space and experts in this field can help providers and patients better understand the data that we do have and where our gaps may exist.

I think, furthermore, various institutions have niche programs that are dedicated to education and research for young women with breast cancer and, within that umbrella, pregnancy-associated breast cancer. So it's really important, I think, to be aware of those resources as well that do exist.

Dr. Fumiko Chino:
You really highlighted something important, which is that in this situation of pregnancy-associated breast cancer, it likely is best to go to a specialty center, you know, a comprehensive cancer center of some variety, or a center of excellence so that you can really rely on both the expertise of the team but also their capacity for building that multidisciplinary team that is, I think, really required to treat a patient with cancer and pregnancy well.

Now, Julia, I personally see some parallels here with exclusions for people during pregnancy and also the exclusions for metastatic breast cancer from research studies. Do you mind speaking about that? I know you've been a strong advocate about inclusion.

Julia Maues:
Yes, absolutely. We see a lot of clinical trials that include metastatic breast cancer patients when it comes to the actual treatment and the new drugs. But when it comes to survivorship trials, and let's say, what is the effect of exercise on your outcome? Patients with metastatic breast cancer are often excluded. And we are surviving too, right? We need to be studied in that scenario as well. And I think we're fortunately seeing some change in that. And there are a few trials, for example, open right now looking at diet and exercise for specifically metastatic breast cancer.

Dr. Fumiko Chino:
It's amazing to think about how you've really straddled both high-risk groups, you know, the pregnancy-associated breast cancer, metastatic breast cancer, and really dedicated your life to making inroads and positive changes for both of these communities. So I really am so grateful for you for that.

We are sort of wrapping up this podcast. I wanted to give a little bit of space at the end to have any open topics, if there's anything that we feel is under-addressed or unaddressed in this topic. I know that we could probably spend, you know, five hours talking about it.

Julia Maues:
I will say one thing that is perhaps the most difficult decision. When I discovered my diagnosis, I was very happy to be pregnant, but I was faced with the question of, I now have a disease that is life-threatening. Am I going to be alive by the end of this pregnancy? And in order to be alive by the end of this pregnancy, do I need to terminate this pregnancy? I think that is a question that was the most difficult one during that moment and is one that I discussed with my team. And fortunately, in my case, it was possible to give me treatment during the pregnancy and still not harm my baby. But I think this is the first thing that we're faced with at that moment of the diagnosis.

Dr. Fumiko Chino:
And I think that concern is certainly even more relevant in the climate where, depending on where you live, that may not even be an option. And even, I have definitely heard some concerns about even chemotherapy while being pregnant could be potentially something that would be at risk. Erin, do you have anything to add?

Dr. Erin Roesch:
Yeah, no, I think that's a valuable point too, is that again, it's a very, very challenging, scary time at initial diagnosis. And just like Julia mentioned, many women are very happy they're pregnant. And even to Julia's point earlier about receipt of chemotherapy during pregnancy, you know, many women might not think that that's possible. We have data that has shown relative safety of certain chemotherapies during pregnancy, you know, after the first trimester. And so I think it's important that again, with the shared decision-making, that women know all of this information so they can process and come to the best decision for themselves.

So, and I think also, not that we can predict the future—I always tell my patients I wish I had a crystal ball that I could tell what was going to happen in the future for people. But I think that we've had a lot of advances in terms of breast cancer treatment, and this includes for metastatic disease. And so our patients are living longer and living better. So I think that's important to remember too. And just again, make sure that we, as much as possible, have these conversations upfront with what we know and what we don't know so our patients can feel supported through this process.

Dr. Fumiko Chino:
That's a really good, positive note to end it on. So I'm so grateful for your time. Thank you for this wonderful conversation today. Thanks to Dr. Roesch and Ms. Maues, as well as our listeners, for your time today. You can find the links to the papers that we discussed in the transcript of this episode.

If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest:

Erin Roesch:

Honoraria

Company: Intellisphere

Consulting or Advisory Role

Company: bioTheranostics

Company: MDedge

Company: Seagen

Julia Maues:

No Relationships to Disclose

Dr. Chino talks with Dr. Atif Khan and Dr. Lola Fayanju about the shift in breast cancer management from reducing locoregional recurrence and improving breast cancer mortality to deintensification, shared decision making, and improved quality of life. This discussion will be based off a JCO OP editorial published in late 2024 called "Contextual Framework for Understanding Treatment De-Escalation in Patients With Breast Cancer."

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Breast cancer treatment has made significant strides in the past century, with the five-year survival rate rising from less than 5% in the early 20th century to around 90% in the present day. In today's episode, we'll be discussing the shift in breast cancer management from reducing local-regional recurrence and improving breast cancer mortality to deintensification, shared decision-making, and improved quality of life. This discussion will be based off of a JCO OP editorial published in late 2024 called "Contextual Framework for Understanding Treatment De-escalation in Patients with Breast Cancer."

I'm excited to welcome two breast cancer experts as guests today: the first author of this editorial and radiation oncologist, as well as a health services researcher and breast surgeon. They're both engaged in research to improve outcomes for breast cancer, including treatment optimization.

Dr. Atif Khan, MD, MS, is a full attending breast cancer disease site leader and Service Chief in the Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. He is also on the steering committee of the Clinical Research Innovation Consortium, as well as on the Research Council at MSK. Dr. Khan is the chair of the breast section of oral examiners for the American Board of Radiology and is active in NRG, helping develop and lead key clinical trials to optimize radiation delivery for breast cancer. Dr. Khan is also a translational science investigator of novel radiosensitizers.

Dr. Oluwadamilola "Lola" Fayanju, MD, MA, MPHS, is the Helen O. Dickens Presidential Associate Professor and Chief of the Division of Breast Surgery at the Perelman School of Medicine at the University of Pennsylvania. She is also Surgical Director of the Rena Rowan Breast Center at the Abramson Cancer Center, Program Director for Implementation Innovation at the Penn Center for Cancer Care Innovation, and a Senior Fellow at the Leonard Davis Institute of Health Economics at Penn.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Atif and Lola, it's wonderful to speak to you today.

Dr. Atif Khan: It's a pleasure to be here. Thank you for inviting me, Fumiko.

Dr. Lola Fayanju: Yeah, thanks for having me.

Dr. Fumiko Chino: The topic today is treatment de-escalation for breast cancer, loosely based on the editorial that Atif wrote in JCO OP outlining a conceptual framework, which is primarily focused on local-regional therapies, i.e., radiation and surgery for breast cancer. The concept of rightsizing treatment has really been developing over the past three decades, spearheaded by surgical de-escalation. Lola, do you mind giving me a brief overview of surgical de-escalation as you have seen it throughout history and as currently realized in your practice?

Dr. Lola Fayanju: Happy to. So, you know, it's one of those things where I think increasingly we recognize that breast cancer is a heterogeneous condition that shares an anatomical space. And with that refined understanding of treating breast cancer, we're no longer using a very blunt and large hammer to deal with what is actually a constellation of nails. So originally, when people used to treat breast cancer, the idea was that you wanted to take as much tissue as possible. And this originated the Halstedian mastectomy, which was a radical mastectomy that often involved removal of not only all the breast and axillary tissue but also the pectoralis muscle, even some accessory nerves, that really left people with incredibly deformed body habitus as well as compromised function. And in part, that was not an unreasonable approach given that disease was often presenting in a locally advanced fashion.

However, as we have been increasingly able to detect disease at an asymptomatic, pre-palpable state, but also as our ability to treat disease at a systemic fashion has become more effective, we've been able to move from the Halstedian mastectomy to then the modified radical mastectomy, and then ultimately to even less axillary surgery, as well as less breast surgery, such that there was the advent of the lumpectomy pioneered by Bernie Fisher in the 1980s, as well as sentinel lymph node biopsy pioneered by Armando Giuliano and Don Morton in the 1990s and early 2000s. And what this allowed us to do, again, is to achieve similar if not better outcomes, because we were again catching disease at an earlier state thanks to screening mammography, but also able to provide more personalized, less morbid care that focused on just the cancer at hand with the additional adjuvant therapy of radiation to provide comparable survival to mastectomy.

What this has allowed us to do is also think about the order in which we do treatment, that is allowing people to potentially get systemic therapy first in order to convert from a more morbid procedure to a smaller, less morbid procedure. So, we've made a huge number of strides both with regards to surgery in the breast as well as surgery in the axilla, and that's been facilitated by a combination of knowing more about disease, being able to be more systemic and holistic in its treatment, and also recognizing that more is not always more. The last thing I will say is that we've also been aided not only by the adjunct radiation and systemic therapies, but also by the ability of our radiologists to localize pre-existing cancer such that we can target the area and just the area of concern, whether it's through targeted axillary dissection or through sampling a previously positive area of the breast, such that we can again be more selective in terms of the surgery people get after systemic therapy.

Dr. Fumiko Chino: Thanks for that great overview, and I really love it how you have highlighted that it's all of these advances that allow us to customize the treatment to the individual. So it's not one size fits all with cancer care. We're really trying to make a customized plan and really rallying all of the modern technologies to make sure that we're rightsizing the treatments for the individual. And I think that provides a lot of benefits for patients.

Atif, can you highlight some of the key steps to de-escalate radiation for breast cancer?

Dr. Atif Khan: I think thematically, we're seeing a very similar sort of trend in radiotherapy. Just as a reminder, radiotherapy is a critical component of breast conservation therapy and also in the post-mastectomy context for high-risk patients. Radiation has been shown to sterilize or reduce the risk of microscopic residual, reduce the risk of local-regional recurrence, and in high-risk contexts, you know, by extension, reduce the risk of all recurrences and even improve survival, for example, in the seminal post-mastectomy radiation therapy trials.

Now, we existed in a time when there was perhaps only one right way to do radiation therapy, and that's not the case now. We have many different ways that we can deliver radiation therapy. And that's important because our, as Lola said earlier, our understanding of different risk strata of breast cancer has also improved, meaning we can stratify breast cancer patients into low risk, intermediate risk, high risk, maybe even very low risk. And therefore, we can tailor the intensification of our local-regional treatments to match the background risk that may exist for that particular patient.

Now, if we consider five weeks of whole breast radiation or five weeks of post-mastectomy radiation to sort of be our historic norm, we now know that we don't have to protract the course of radiation out like that. We can treat that same target volume, for example, the whole breast, with a shorter course of radiation that generally is given over three weeks. Now, I do want to pause here for one second just to clarify for everyone listening: taking five weeks of whole breast and doing that over three weeks is not necessarily a de-escalation per se, because really the same biologically effective dose is being given. It's just being given faster. So it's not really a treatment deintensification or de-escalation per se. Now, it is less disruptive to patients, it might be less, say, financially toxic, for example, in terms of like missed days of work, etc., but it's not a de-escalation with respect to the intensity of the treatment. It's just the same treatment being given shorter, but we know that it's safe to do that.

In contrast, partial breast radiation is, in fact, a de-escalation because now our target volume is no longer the entire breast, rather, we're just treating a part of the breast, that part of the breast where the risk primarily is, which is in the index quadrant where that original breast cancer was. And at the, let's say, at the low end of the risk spectrum, we now have very good evidence, you know, 14,000 randomized women, demonstrating that, in fact, partial breast radiation in those contexts is just as good as whole breast radiation. And I always sort of half-joke that whenever this treatment is possible, we should use it because for a fibroblast sitting in the breast somewhere minding its own business, a day without radiation is a good day, right? So if we can spare that treatment to uninvolved normal cells, we should try to do that.

And then, of course, the ultimate de-escalation is to identify patients who don't need radiation at all and just omitting radiotherapy. And really across the risk spectrum, whether it's in breast conservation or whether it's in PMRT/regional nodal radiation, we are seeing the emergence of these different types of treatments, meaning kind of like the high-risk treatment, the intermediate-risk treatment, and then at the very low end of the risk spectrum, no treatment at all. But that's sort of the practice that we're living in now, and I think it's a good one. We're making progress.

Dr. Fumiko Chino: I appreciate that. The whole idea is if we can potentially omit treatment to certain areas of the body or if we can omit it completely, we're certainly doing a favor for our patients if it's not going to increase their overall risk. We had talked, I think between the two of you, about some of the benefits of potentially omitting or reducing morbidities from, for example, surgeries or comprehensive treatments. Atif, do you want to take it first? What are the actual de-escalation risks? What are we potentially putting at risk when we talk about de-escalation or deintensification?

Dr. Atif Khan: Yeah, great question. I mean, I think the primary risk, which is, you know, a scary thought, is that we de-escalate or we do it too quickly or we find that, in fact, reducing the intensity of treatment leads to an increase in the recurrence risk of breast cancer. That's a very scary thought. I will say that this process of creating options, you know, treatment options, de-escalated treatment options, has been quite successful. For example, I'll open it up to Lola and you, Fumiko, but I can't really think of a clear example in which the de-escalation trial went in the wrong direction. Like, they've all sort of gone in the same direction, which is that the de-escalation or deintensification studies have generally been successful, meaning that we were able to preserve the excellent oncologic outcomes that we are used to seeing with less treatment. That's a testament to kind of how careful, you know, the scientific process is with respect to these practice-defining trials. They go through multiple levels of scientific review. It's a multidisciplinary group of individuals that's looking at this. And I would say the endeavor overall has been quite successful.

Dr. Fumiko Chino: Lola, anything to add?

Dr. Lola Fayanju: Yeah, I think when we're thinking about the risk of de-escalation, I would put them into three categories of risk. So, there are risks to the individual, that is, you know, we're actually de-escalating in the wrong person because we have an insufficient amount of information about whether they meet the criteria for de-escalation.

There's, I think, risk to the population in terms of are there groups of people who are systematically not benefiting from the de-escalation or who should not be benefiting from de-escalation because again of an underappreciation of how disease might work in that group or because the practice patterns where those people are getting care will not be amenable to de-escalation ultimately being of a good thing for them because they're not getting the other components of care that frankly are needed for de-escalation of one modality.

And then three, I think there's a risk to our collective knowledge about cancer because when we're not collecting information about what happens after six weeks of radiation or how many lymph nodes are positive, we just know a little bit less about the natural history of the disease and the natural sequelae of treatment. Again, that knowledge may be worth forgoing given the morbidity to patients and the non-benefit with regards to recurrence and survival, but it's real. It means that our retrospective reviews look different. It means our ability to have preliminary data for other types of things look different. With regards to the populations, it means that whenever we're thinking about de-escalation, we need to think hard about how to translate what we see on the podium at San Antonio or ASCO into clinical practice. And that requires, I think, more care than is often administered.

Dr. Fumiko Chino: Yeah, I'll quote directly from the manuscript of the editorial that we are basing this podcast on, and it said basically, "American women ascribe a high utility to remaining without evidence of disease." And that really sticks with me in that, even though there may not be a survival benefit, an increased risk of recurrence is not without a personal, financial, and physical burden on patients, even if that difference is small, it may be meaningful for the person in front of you.

Now I'll also shift focus slightly and just mention that we're primarily talking about local therapy here, but I'd be remiss to not highlight that there are gains in de-escalation for systemic therapies from, for example, RxPONDER, allowing us to safely omit adjuvant chemotherapy for many node-positive patients; B21, showing that monotherapy with radiation may be actually even better than tamoxifen monotherapy with no metastatic or survival differences; and of course, the PERSEPHONE trial that demonstrated that six months of trastuzumab was non-inferior to 12 months, although, granted, there were many caveats leading to poor adoption of this in practice.

Now, Lola, I know you've already mentioned this, but there are maybe some concerns that you see about broad adoption of these practices into, for example, surgical de-escalation. Based on what I know is stark disparities in clinical trial enrollment in certain populations or in maybe even clinical trial protocol adherence, are there any specific populations that you want to highlight that might be hesitant to apply this clinical trial podium data to?

Dr. Lola Fayanju: That's a great question. So, as an example, when we think about the SOUND trial, which was recently published and demonstrated that in women with early-stage breast cancer who were undergoing breast-conserving therapy and had normal axillary evaluation prior to surgery, that sentinel lymph node biopsy could be safely omitted without detriment with regards to long-term outcomes, you need to think about the context in which that preoperative ultrasound is being done. So, at different institutions, whether or not an ultrasound is routinely done, whether or not that ultrasound is done prior to biopsy, all of these things have implications for how likely you are to have a false positive after biopsy (so it's preoperative, but it's post-biopsy) and also what you're going to do about it, whether you're going to act on it, whether you're going to go ahead and proceed with sampling that node if it looks enlarged, putting something in it that means you retrieve it. If it demonstrates a small amount of cancer, potentially consigning someone to either an axillary dissection or preoperative systemic therapy that they might have forgone had you had the full picture of surgical pathology.

So that's just one example of how the context in which implementation occurs is really important because you have to take into account local practice patterns and what that means with regards to how we interpret the data that was used in the trial to then implement this practice in real life.

With regards to populations that need to be considered, I think in terms of centering equity, both domestically but also at a global level, thinking about, for instance, how we stage the axilla, how we map the axilla. What's the facility for lymphoscintigraphy as well as for localization of a previously positive node? So, there are many countries, many quite wealthy countries, in which use of radiocolloid is not routine, where it is primarily that people are using some type of tracer blue dye, for example, and therefore would not strictly be meeting the criteria for optimal sentinel lymph node mapping that would allow for a low false negative rate after neoadjuvant systemic therapy.

In the United States, we might be in places where you have patients who are having surgery with people who don't do that much breast surgery and who are less likely to have a successful and correct yield of lymph nodes at time of sentinel node biopsy. And so, you know, these are people for whom there might be actually clinically significant disease that's being left behind if not being done by someone who has a lot of experience working with dual tracer as an opportunity to localize a preoperatively positive lymph node. So again, thinking about both the availability of materials as well as the expertise of the local practitioners means that people in less or differently resourced settings may not benefit from implementation in a way that actually leads to appropriate outcomes.

Dr. Fumiko Chino: Yeah, I love it how you highlight that there's global differences, but there's also just in the US differences in capacity and skills within doing these, some of these presurgical and surgical evaluations. All three of us work at world-leading cancer centers, and I recently just transitioned from two top cancer centers in the United States, but I was actually kind of shocked about the differences even between the two major centers about how we do ultrasounds, for example.

Now, Atif, I've noticed that some providers don't really feel comfortable combining the information from various de-escalation trials in practice, i.e., so for some patients that might have had sentinel lymph node biopsy omitted per SOUND, they may be less likely to actually get PBI and instead, you know, prefer to treat whole breast radiation to cover the axilla. So, in this respect, it seems like we're kind of taking like one step forward, one step back. And are we de-escalating surgery to just escalate radiation?

Dr. Atif Khan: Fumiko, I agree with you. It'd be very counterproductive if we found that de-escalation in one domain was leading to escalation in another domain. I think the example you cite is a good one. If we are moving to a world without sentinel node biopsy and let's say clinical staging only, does that then mean that we have to, for example, give up on partial breast irradiation and treat everybody with whole breast radiation on the notion that low axilla, for example, is going to get some therapeutic effect? And I would submit for everyone's consideration that no, we in fact should not do that. We spent years developing the partial breast irradiation literature. We know that PBI has less acute toxicity. In every single trial, it has less fatigue, and it actually has less late toxicity in some studies, which is not surprising because remember, you're treating less tissue, you're treating less stuff, and that's a good thing.

Now, coming to SOUND and INSEMA, on the sentinel node arms of both of those studies, the rate of additional positive nodes is very- around, 10%, and that's pretty low. So I would submit for everyone's consideration the idea that if your patient is node-negative by SOUND criteria, let's say, right? They're very likely to be pathologically node-negative. And you can actually treat them as if they were pathologically node-negative. And that's kind of how we've adopted the findings of both SOUND and now also INSEMA from San Antonio, meaning that if a patient is eligible for PBI based on everything else, and she is node-negative by SOUND criteria, then we will offer them PBI in exactly the same way as we were before these trials were reported.

I also wanted to make one observation on your prior comment, Fumiko, if I may, about the de-escalation of systemic therapy. One thing that has been on my mind quite a bit is, particularly with, let's say in the elderly group where we have been struggling with kind of like the best monotherapy, right? Should it be five years of endocrine therapy? Should it be a short course of radiation, or do patients really need both of these treatments? And this is topical because the EUROPA trial, one of the endpoints was reported at San Antonio, the quality of life endpoint. Not surprisingly, a short course of radiotherapy was sort of associated with better quality of life than the endocrine therapy.

But I think we may be missing one potential opportunity in this sort of idea of like, we have to either do the radiation or the endocrine therapy, which is we might be able to give a little bit of systemic therapy and a little bit of radiation therapy. This line of investigation or line of thinking doesn't really exist right now. Like that conversation is interesting. So for example, can we give, for number one, can we go from AI back to TAM, right? Because AIs are just, there's just, the quality of life is worse. And can we give a lower dose of the TAM, monitor for compliance, and then give a little bit of radiation, you know, let's say PBI or something? And maybe that's the way to do that. And you could take that idea and you could apply it across different contexts even in breast cancer. And I'll note that that is how kind of the Hodgkin's lymphoma treatment evolved over time. At the low end of the risk spectrum, they kind of said, "Okay, a little bit of chemo and a little bit of radiation is better than just giving a lot of chemo or certainly a lot of radiation." And you know, that worked. And I think at the low end of the breast cancer risk spectrum, we might start thinking about that kind of line of investigation.

Dr. Fumiko Chino: You want to 'Goldilocks' this situation. You want to try to find something that's just right. And I love that. And I think that sort of out-of-the-box thinking is very helpful when we think about how omission seems very clean, "you just don't get this," but deintensification, simultaneous deintensification, I think has a lot of appeal there.

Lola, do you have anything to add about that?

Dr. Lola Fayanju: I have to acknowledge the bias of three local-regional therapists on this podcast, I'm outnumbered by our two rad oncs. But just wearing my medical oncology ally hat, I think one of the challenges is also that for many of them, the ability to prescribe effective forms of systemic therapy, including CDK4/6 inhibitors, for example, is sometimes predicated on information we obtain at surgery. So, when we think about implementation, which is really, you know, an area of research for me, whether it's trying to implement the SOUND trial, again, in an institution where everyone's getting an ultrasound prior to biopsy, absolutely. But in an institution where either it's completely ad hoc, so it's kind of the 'wild, wild west', you have no idea from radiologist to radiologist who's doing ultrasound before or after biopsy, and also frankly, what is the kind of false negative rate at that institution, recognizing not everyone's working at the kind of places we work at. Are we doing patients a disservice?

But then, in addition, thinking about working with insurance companies, right? If we're trying to say, "Okay, we are no longer going to do sentinel node biopsies," but that's actually required for the administration of certain medications, we put our medical oncology colleagues in a bad position in terms of their ability to actually get certain types of treatments paid for and approved. And so again, thinking about the consequences of our choices for patients, I think it really points to the fact that multidisciplinary consultation is increasingly going to be needed because we can't de-escalate everything. I think we all agree most cancers need to be treated in some fashion. But, you know, if we take away surgery, we take away radiation, we take away systemic therapy, suddenly we have a cancer that's just sitting there. And for some people, that's the right thing. Again, thinking about shared decision-making, for some patients with other morbidities and/or older age where they're unlikely to have any kind of meaningful threat from disease being left in place, well, that is the right thing potentially. But for a majority of our patients who actually want some form of treatment, I think we do need to think about the implications for our other prescribing providers, what that means, how we can help them, even as the clinical trial data suggests that there aren't major changes in adjuvant therapy or radiation prescription when you omit sentinel node biopsy, at least in the trials that have so far been shown.

Dr. Fumiko Chino: This is a nice segue to my last point, which is to talk about how these discussions of de-escalation, these decisions should really be made after the full multidisciplinary input. And yet, I feel like I've seen our specialties get increasingly disconnected in this kind of era of Zoom conferences. There seem to be less face-to-face meetings. There seems to be decreasing space for our co-shared clinics. And I just wanted to ask both of you what you think our responsibility is to each other and to our field to ensure that we're really working on these things synergistically.

Lola, you just mentioned some of your thoughts, but do you mind speaking about the multidisciplinary conversation or even how we're designing research?

Dr. Lola Fayanju: I think, with regards to the research, I'll start with that first, it means that, I think we're less going to have trials that fit in certain kind of cooperative groups that are more geared towards radiation or what have you. I think, increasingly, we should be having MPIs, you know, co-PIs who are from different modalities. I think that that's going to allow us to bring our different lenses to constructing the trial, to ultimately interpreting the result. I think we'll only grow from that. I think the era of having a bunch of medical oncologists or surgeons or radiation oncologists as the primary authors really should probably shift.

I think we need to think more globally about multidisciplinary care and what those, quote unquote, "tumor boards" should look like. And thinking beyond our own institutions, again, we're relatively privileged in terms of being at places where we all have at least weekly, if not bi-weekly multidisciplinary tumor boards. Most cancer care in the United States is happening in the community where a patient walks into, often a general surgeon's office, and that person will get surgery upfront whether they need it or not, or whether they should be getting systemic therapy or not first. And then from there, they will then be referred to a medical oncologist who may have had no input as to which procedure should have been omitted or discussed or vetted prior to meeting that person. And so, I think our greater challenge is how to bring in the global oncology community, and by global, I mean truly across the globe, across the United States, across the world. And it might be that ASCO and JCO, places like this for discussion, is an opportunity for us to connect people, connect our communities, and not having us work in silos, both at the institutions in which we currently are employed, but also at a broader level.

Dr. Fumiko Chino: Wonderful statement. Atif, anything to add to that?

Dr. Atif Khan: Yeah, I think you're pointing out an important thing, Fumiko, which is, you know, we are somewhat more fragmented since the pandemic, and we're kind of in our own spaces, and that is potentially a problem. I think in breast cancer, the different specialties are often existing in kind of a very cooperative matrix, and I think that ends up meaning that we're able to really provide high-level care to our patients. I think there are other specialties, I know, where the specialists may be existing in a somewhat more competitive matrix with each other, and I think that ends up potentially being counterproductive for patient care. So I think this is probably a thing that we need to have more conversation around and sort of thinking about how do we bring the different vantage points together in the interest of the patient and not lose that multidisciplinary care that we'd become so used to and that's provided such excellent outcomes.

I think on the research side, I don't want anyone to sort of be left with the idea that there's just one specialty that's sort of driving, you know, the design of these trials. From my own first-hand experience, both at Alliance and NRG, there's a lot of scientific review that happens, and I spent quite a bit of my energies over the past decade and a half kind of convincing medical oncologists that a certain local-regional question is warranted. And, and you know, that's part of the process. I appreciate that because they're not just experts in their field. You know, we all eat, breathe, and live breast cancer. So, you know, they have keen insight into the local-regional management as well.

Dr. Lola Fayanju: Yeah, I have to say I love the cooperative group meetings. That's kind of where the sausage gets made. And I think it is really exciting that you have people from different disciplines sitting together, proposing trials, vetting them. It feels like you're seeing the future in the present, which is really exciting. And, you know, I think what we're all striving to do.

Dr. Fumiko Chino: I love that hopeful conclusion, and I really am so grateful for both of you for this wonderful conversation today. Many thanks to both Dr. Khan, Dr. Fayanju, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, I encourage everyone to continue doing the work that they find meaningful for their patients, for their community, and for themselves.

Dr. Atif Khan: Thank you.

Dr. Lola Fayanju: Thanks so much.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Atif Khan: Stock and Other Ownership Interests: Novavax, Xtrava; Research Funding: Clovis Oncology, Merck KGaA, Varian Medical Systems; Patents, Royalties, Other Intellectual Property: Use patent for the drug riluzole awarded to Rutgers University with me as inventor.

Oluwadamilola Fayanju: Research Funding: Gilead Sciences

Dr. Pennell talks with Dr. Daniel Richardson discuss physician burnout and the author's curriculum designed to mitigate burnout and foster solidarity among fellows.

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-US.com.

Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP.

Today, I'd like to talk about a topic that's at the front of many people's minds, burnout. With what seems like constant stress and increasing demands on our time, many clinicians are feeling increasingly exhausted, cynical, and like their work lacks meaning. These elements are part of a condition known as burnout. And it feels like everyone's feeling it to a greater or lesser extent these days. While employers and training programs are increasingly aware of the issue of burnout, what are they doing to reduce it or to prevent it from happening in the first place?

With me today to discuss this topic is Dr. Daniel Richardson, hematology/oncology fellow and AHRQ postdoctoral research fellow at the UNC Chapel Hill Lineberger Comprehensive Cancer Center. We'll be discussing his and his colleagues' paper, "Development of an Art of Oncology Curriculum to Mitigate Burnout and Foster Solidarity among Hematology/Oncology Fellows," which is part of a special series at the JCO OP on physician wellness burnout and moral distress. Welcome, Daniel, and thank you for joining me on the podcast.

Thanks for having me. It's really a privilege to speak with you today. I'll start off just by noting my conflicts. I have no financial conflicts of interest to disclose. However, my institution was involved in the study that we'll be talking about.

All right, thanks for that. So burnout is something I think most physicians and other clinicians can relate to. But would you mind just kind of giving our listeners a little brief overview of what exactly is burnout in physicians and how big of a problem is this right now?

Sure. So burnout was first described really as a metaphor to talk about an extinguishing of a fire or smothering out of a fire. And it related to this loss of capacity that many feel to make a meaningful and lasting impact with one's life or career.

More recently, it's been further clarified to cover several domains of this initial concept, including emotional exhaustion, depersonalization, and loss of meaning or purpose at work. And burnout really has been shown to lead to profound of personal and professional consequences-- anxiety, depression, and in the professional realm, attrition among physicians and oncologists and decreased quality of care. And the problem is pretty pervasive, as most of us are aware. Our most recent studies show that nearly half of practicing oncologists are experiencing burnout and about a third of residents, fellows, and medical students even are experiencing burnout.

Yeah, this is what, I think, a lot of our listeners might be interested to hear about. There may be a conception out there that burnout is a function of time-- you know, being exposed to something over a long time maybe later in your career. But what you're saying is that this is something that people can start to experience almost immediately, even in medical school and during residency. And I find that really interesting, although potentially disturbing as well.

Yeah, I agree. And I think what we're seeing is probably the results of a larger change in our culture. We're seeing kind of a loss of sense of meaning and purpose and connectedness to the community in the larger culture. Increasingly, we're seeing that medical students, residents, and fellows are lacking a deeper sense of meaning and purpose in the broader community. And that's really playing out in their role as an oncologist as well.

So I'm curious what led you and your fellowship program to developing this kind of a curriculum to try to combat burnout.

Sure. Prior to medical school, I completed a master's degree in philosophy of religion and ethics. And it allowed me the opportunity to think a lot about virtue ethics and also the moral foundation of medicine. And virtue ethics is really focused on human flourishing and really claims that the path to human flourishing is developing character and virtues that can lead to that.

And so I thought a lot about who I was becoming as a medical student, who I was becoming as a physician in medical school and then into residency. During my first year of fellowship, I was thinking a lot about the culture of medicine and how I was developing in the midst of that. And I really became aware that there was a clear lack of direction on how to help fellows develop into oncologists that would be able to thrive in their careers.

We didn't really talk about calling. We didn't talk about purpose. We didn't talk about who we were becoming. We were being trained as oncologists with the right answers about treatment. But as one of my favorite authors, C.S. Lewis, puts it, we were at risk of developing into oncologists without chests-- that is, without a deeper understanding of the meaning and purpose of what we did each day. It really kind of started with this bigger understanding that we were going through this big process, and we were becoming oncologists without really thinking about what that process was looking like and how that was happening.

Wow, I think that is-- that's fascinating. Well, in any case, since this led you to design the program, can you take me through the design of the Art of Oncology program that you designed? And what are you hoping to show as a result?

Sure so as I had mentioned, I was really thinking a lot about who we were becoming as oncologists. And so one of the first things that I thought about is, how can we foster a sense of meaning and purpose in our fellows. I thought that this was really a place where we are seeing a lot of burnout is that there is this lack of meaning and purpose among fellows and oncologists in general. And so we wanted to target that. So we landed on a curricular intervention that used narratives, really to promote a shared mental model of meaning and work, which all that really means is helping all of us have a discussion to understand where we are coming from, our experiences, and how we are being shaped in the midst of kind of caring for patients. And our hope in kind of starting from that point and developing a narrative model was really that we could help fellows understand where they sat in caring for patients, their calling in doing that, and then also their position as a part of a broader community that had a bigger vision for caring for patients as well.

So we decided that we would use personal and published stories, mostly about caring for cancer patients, to spark discussion, reflection, and then really a deeper understanding among fellows of this shared calling. And we had faculty or, often, patients come and share their story or one of the narratives in those sessions. We planned eight sessions throughout the year, which took place during the traditional didactic lecture times. And the narrative took place over the first 15 minutes or so. And then the point was really to foster this deeper discussion and reflection on meaning, identity formation, and moral development in medicine.

So a lot of this really was based, then, upon selecting the different essays and other pieces of literature that you were discussing. So how did you end up picking those?

That's a great question. And I think we wrestled with it a lot. I think initially, we, as a group, found those essays that were most meaningful to us. And we felt like they would really speak to the fellows. But as we thought about it more, we really wanted to collect them around a few themes. And as I've been talking about, I fundamentally believe that finding meaning in caring for suffering patients is essential to mitigating burnout. So this was kind of the primary theme that I focused on.

But we also, in the midst of the program, wanted to equip fellows with skills to foster their sense of purpose in medicine. So we had a session focused on cultivating virtues of resilience and self-care, as well as sessions on caring for dying patients. And we really understood that the experiences of most fellows were very hard, given the immense amount of suffering that they experience.

So our initial hope would be that really, this session and this program would be an avenue to redeem some of the suffering that the fellows were experiencing through their patients. We hoped that it would lead to a deepened sense of community or solidarity is the word I use in the paper, among our fellows, and that this sense of belonging in one's profession really becomes vital for the sustained success. And I was really hoping that this would be fostered in the program as well.

You had mentioned earlier about what you were hoping for. Although we knew that we wanted to target a reduction in burnout among fellows, we recognized that burnout is really a multifaceted concept. So we knew that a small pilot program would be unlikely to see a substantial improvement in burnout. But we wanted to really shoot our or our aim our intervention really at the roots of developing burnout over a career.

So how did you try to measure that? So I mean, first of all, I've got to say, this sounds amazing. And I could say it may have value just in and of itself, because it's such an interesting and cool concept. But as scientists and trying to study things, how would you measure this kind of improvement?

Yeah, so that is probably the fundamental challenge, to be honest. And I, first off, want to say, I 100% agree with you. I think it's a first principle of medicine that we need to, as a community, think deeply about how to care for patients well. And we need to help each other to thrive in medicine. So I don't know how you'd necessarily capture that on a scale.

There are well-developed burnout scales, the NBI being the most prominent. We worry a little bit about having our fellows go through extensive surveys in the curriculum. So we used a couple surrogates. So there are three one-item measures that we used at the beginning and then the end of the curriculum.

And then we really wanted to capture the experience of the program as well. So we had fellows fill out basically subjective surveys about their experience with the program. And then also, we captured their attendance in the program. Our aim was really to establish, first off, is this something that is possible to do, good fellowship programs do this. And then really, did fellows enjoy and participate in the program as well.

You mentioned about not wanting to put a bunch of surveys on top of people. And so one of the first things that occurred to me when I was reading this paper is, were you concerned when discussing adding this that fellowship curriculums are already quite busy and filled with lots of sessions and other duties and whether this might actually make their burdens worse by adding extra sessions and requirements?

Yeah, for sure. We didn't really know what to expect. And we didn't even know if the Fellows would show up and participate. There is fear within our culture of being vulnerable, of owning that the suffering of our patients is getting to us and that we need some help. And I was really afraid that fellows would feel like the sessions were cheesy or forced and that the fellows would be uncomfortable being honest in the sessions.

There is a perpetual concern about adding more into the lives of fellows that will lead to greater burnout. You know, it's the running joke about filling out a weekly 25-question burnout survey among our fellows. So we really wanted to design a program to limit the requirements. Fellows really just had to show up and participate. There is no required readings or homework.

And we limited a few didactic sessions that used to be in the place where the Heart of Oncology sessions were in order to make room in the schedule. And we tried hard to make the sessions adaptable to any environment so that it was really just having a narrative prompt, getting people who care for cancer patients together, and thinking deeply about some of these issues that was really at the heart of the program. So we tried to limit a lot of those extra requirements for the program.

Well, it sounds like you definitely thought about that and tried to make it as least burdensome as possible. And it sounds like you were able to do that. So tell me, what did you learn from this first year of the program?

Well, it was really fun at first. And so as a fellow myself, I was able to participate with the other fellows. And that was really wonderful. I had a great time with them and learned a lot about them and felt like it was really enriching for me.

We saw, really, that the fellows really enjoyed the curriculum as well. They really loved the opportunity to think more deeply about these issues and also to hear how their colleagues were wrestling with them and to dialogue about some of the issues that we often don't talk about. They felt it improved the sense of community among the fellows and helped with some of the daily challenges of dealing with the suffering of their patients.

They pointed to some practical skills that they took away from the sessions, including managing work-life balance, communicating bad news, and having a better understanding of the challenges faced by patients. Surprisingly, many of the sessions were really emotional for the fellows, where they were able to share their stories about losing patients or family members to cancer.

We didn't see a statistically significant improvement in burnout. And as I mentioned previously, this is a pilot intervention. So this is not wholly unexpected. As you mentioned prior as well, that with such positive comments from the fellows that the sessions were beneficial in and of themselves, and really that we would hope that there would be long-term benefit as well. I don't know if such programs to foster moral development would actually be expected to result in immediate improvements in burnout. So the goal was really to begin to cultivate the virtues that will have lasting impact over a career in medicine and not necessarily to impact the burnout that follows were experiencing in that moment.

So you are describing the first year in your paper here. So what are the next steps? And based on what you've learned, are you planning any changes?

Yeah, so Dr. Collichio and I sit on the ASH ASCO Milestones committee, which are working to develop some metrics to capture fellow well-being at each fellowship program. And so we are hopeful that these metrics begin to lay a foundation to expand the art of oncology programs and other fellowship programs. We've been in contact with other programs that are eager for such an intervention and to get it rolling. And so I welcome other fellowship programs to join in as well.

The ideal study design to test this intervention is a multi-institutional cluster randomized trial. But really, I think we're still at the nascent stages of the development of such interventions. So this will likely be something that will happen years from now. And again, I think we realize that while we want this intervention to really impact on burnout, we want the intervention to have something deeper in terms of developing the character of our fellows. And so rolling it out among fellowship programs is going to have benefit across the board.

So what changes are we making to the program? We're in the second year of the pilot. And we haven't had too many changes, apart from, again, limiting the amount of requirements that we have for the fellows. Last year, the fellows really loved having patients come and speak and share their stories and how they interacted with the health care community. So we increased the number of times that patients would be coming. And we started to have more of our senior oncologists come and share their journey in medicine, kind of a career perspective to the fellows, and allow them to really begin to build some mentoring relationships.

Well, Daniel, I think this sounds absolutely fantastic. I wish we had something like this when I was going through fellowship training. So Daniel, any closing thoughts before we wrap up?

I'd like to comment that programs like these are simply part of a larger whole. Much of the increase in burnout we are seeing in medicine, as I mentioned, is part of larger societal epidemic of the loss of meaning and purpose for individuals. I believe that the epidemic of burnout in medicine is not going to simply be reversed by programs, but rather by a deeper change in the culture.

As an oncology community, we need to recapture our calling of service to suffering patients. We need champions who can lead the way in this and serve as mentors for fellows on how to care for patients well and to model how to find joy in their careers despite the suffering and losses they experience. It is only by recapturing this deeper calling that we can inspire and train fellows to do the same. And I'm hopeful that programs like this one and other similar programs across the country to bring fellows together to think deeply about their calling, their personal calling, and then also their calling in the midst of the oncology community, will serve to do this as well.

So Daniel, thanks so much for joining me on the podcast today.

Once again, this is such a privilege. Thanks so much for having me.

And until next time, thank you for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JCO Oncology Practice podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper is available online at ascopubs.org backslash journal backslash JCO OP, posted in February 2020. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

Dr. Pennell and Dr. Lisa Lowenstein discuss decision coaching in the LDCT setting and how it provides an opportunity for patients to confirm their screening decision by ensuring they are truly informed.

Hello and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs, covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP.

Lung cancer is a huge public health issue. It's our number one cause of cancer-related mortality, and a big reason for that is the lack of a widespread screening tool which results in most of our patients ending up with advanced disease at diagnosis. Although, low-dose CT screening has been proven to reduce deaths from lung cancer for a number of years now, uptake among eligible patients in the United States is very low, well under 10%. Part of the problem may be a poor understanding of the risks and benefits of screening CT, despite broad recommendations for shared decision-making between providers and patients.

Why is uptake such a big problem, and can shared decision-making be improved to help increase screening rates? With me today to discuss this issue is Dr. Lisa Lowenstein, assistant professor in the Department of Health Services Research at the University of Texas M.D. Anderson Cancer Center. We'll be discussing her paper, Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose CT Setting, to be published in the February 2020 JCO OP. Welcome, Dr. Lowenstein, and thank you for joining me today.

Thank you. It's wonderful to be on.

So can we start out by telling our listeners a little bit about the landscape of screening for lung cancer today and the role that shared decision-making plays in this process?

Yes. I think we're in a very exciting time in terms of lung cancer screening, because this is the first time that we have a screening test for lung cancer which is the number one cause of cancer deaths among men and women in the United States. It's really notable that CMS included shared decision-making in their policies for lung cancer screening, because they recognize that, unlike breast cancer and colon cancer screening, we're changing the game a lot of bit here. So we're saying that only high-risk individuals should be screened. So it's not all-comers, and I think telling people about the potential benefits and harms is beneficial. So they go in being a little bit more informed about what the next steps will be, and it is a complex process, and overall, it's still in its infancy.

Yeah. I think a lot of people found it interesting that, in order to reimburse for lung cancer screening, that CMS required this documented shared decision-making visit which on the surface seems like a very reasonable thing. But do you think that's really helping, or is it hurting?

Lung cancer screening is really in its infancy, and it's a complicated process. So we're not just talking about you just show up, and you show up for a scan. Right? We're not where breast cancer screening is. We don't have mobile scans out there. It's taken decades for those programs to get where they are, and I think shared decision-making is just adding one more step and just emphasizing that it's really a program that you're committing to.

And the other aspect is that we really want to highlight that it's not lung cancer screening is enough to prevent lung cancer. Right? It's just detecting it, if you have it. But the best way you can reduce your lung cancer risk is by not smoking, and I think by inserting the counseling and shared decision-making visit, we're reiterating that message to our high-risk smokers and former smokers. Primary care providers, or any providers, aren't even talking about lung cancer screening.

Two, not a lot of facilities may be listed in the American College of Radiology Lung Cancer Screening registry, but their volumes are very low, and they may not actually have the proper equipment or machines to conduct the lung cancer screening. Third is that, if there is to be something to be found on the scan, we don't have processes in place to deal with all the abnormal findings. So I think those are all the things that providers and networks are trying to figure out, and they're trying to figure out like the cost benefit from the reimbursement issue. Because CMS reimburses this scan for a very low cost, and it's lower than what's reimbursed for breast cancer screening.

That's interesting, and in your paper, you mention that, as of right now, something around 6% of eligible patients are getting screened for lung cancer. Which is disappointing, because the studies have been out for a while now. You mention about some of the institutional issues and awareness and providers. Are there any other reasons out there that are limiting this? Because this is something that should be saving lots of lives, and so far, it just seems like it's not making much impact.

I think so, and I think it's misguided in some sense. The reimbursement is not-- you don't have to submit a reimbursement for the counseling and the lung cancer screening. A screening facility can still be reimbursed for the scan without the 1 to 1 ratio of a counseling in shared decision-making billing code, if that make sense.

That's interesting. I didn't know that.

Yeah. So the reimbursement is definitely not going on 1 to 1. I just think, it's a complicated process, and if you were doing a study in Texas and we're serving as many screening facilities as they can in Texas, and I can tell you, a number of them are not doing a high volume of scans. And a lot of primary care providers are trying to find screening facilities that are doing low-dose CT, and it's really hard to navigate the American College of Radiology Lung Cancer screening facility to find a facility. It's about 15 to 20 clinics or something like that.

Wow.

So we tried to look for it on a number of occasions, and it takes us multiple tries every single time.

Well, it's obviously a complex issue, and there's more than one reason for the low uptake. What was the specific issue that led you to do this particular study, and do you think that improving shared decision-making can improve uptake on lung cancer screening?

I think the main issue that we were trying to address here is that, one, we recognize that primary care providers may not be the best-suited individuals to provide the counseling shared decision-making visit. Instead, they may just want to do more of a referral process, like what they're doing in the Cleveland Clinic. Right? Where they say, somebody's potentially eligible, so I'm going to send you to a one-stop shop type of setting. And our radiologists who are leading our lung cancer screening program really wanted to start building this and test it out as an alternative delivery model for the counseling shared decision-making visit which wasn't proposed by CMS or the task force recommendations.

So can you take us through your study design?

Sure. So it was really a pre/post kind of study, really with a quality improvement mindset, as well as using some elements of implementation science, so we can make it relevant more generalizable in our findings. But we first had our period of where they just did what they normally do, where the patients show up. They go and have their scan. They have their normal intake process, and that's it for the lung cancer screening. Then, in our post, we embedded a tablet interactive decision aid, decision coaching module.

So what happens is the patient has the iPad in hand, and they have some patient-facing education talking about the benefits and harms. It's very fast and quick. Patient can get through it and two to three minutes, five minutes if they're not tech savvy. And then we have an advanced practice provider sort of talk about what do they know about the benefits of lung cancer screening? What did they know about the harms, and what are their primary reasons for wanting to be screened, just to kind of confirm their issue, confirm their decision to be screened.

And so what did you end up finding with the intervention?

What they found is that, one, with the decision coaching aspect of it, the advanced practice providers can deliver all the key elements that are required for the counseling and shared decision-making to defer CMS reimbursement. So I think that's really important, in the sense that so much of what we already see in the literature, providers talk a lot about the benefits of screening, but they don't note any potential harms. And it's really important to notice that screening is not without its downsides, and that with an abnormal finding, there is inherent risk. It's not like you're just getting a picture taken. There are steps that need to be followed afterwards.

And the other thing is that what we really like and what our clinical operations people appreciated is the fact that this embedding entire new process did not increase the throughput time for the time that the patient checks in to the time that that patient checks out. Because every institution is paying a lot of attention in money, as to what is throughput time and making sure that it's not too long. And from a patient's anecdotal evidence, the patients appreciated that additional process, because it broke up the time between the waiting periods in between each step.

Yeah. I think that's an incredibly important point that you point out, that they didn't really increase the visit time, but how did that work? The intervention took place during a time that they'd normally be waiting or doing something else?

That's basically what it is, because we did time-motion studies in the pre and in the post. So we followed patients from the time they checked into the time they checked out, and we cataloged what they were doing. And what we saw when we looked at that data in more granular level is that the time was shifted from waiting periods to active time.

That's great. That's really important that you were able to show that. I thought it was interesting that you commented in your paper about the different elements of the shared decision-making visit. That in fact, what we might think of as the primary reason for doing it, which was the element of reducing mortality or their chance of dying of lung cancer, was actually the least important part of the shared decision-making visit. Why do you think that was?

I don't know if it was the least important part. It's just that we had some slides dedicated to it for the decision coaching, but there are so many more harms to talk about, and it's also an artifact of the context to where this intervention took place. So we took it, we were dealing with patients who had already been scheduled to be screened. So we were just confirming their decision, and I think the advanced practice providers knew that. So they might have glossed over the benefit, because otherwise, the patients wouldn't be there, if they didn't value the screen.

Mm-hmm. I guess that makes sense. They knew why they were there. Is there a next planned follow-up study for this?

Good, I'm glad you asked that. So using this data, we're testing this more centralized model and using it in a different setting. So now, we're taking this into a quit line setting. So we have a Cancer Prevention Research Institute of Texas, or CPRIT, grant that's looking at the decision coaching being delivered by tobacco treatment specialists via phone.

So a primary care provider identifies patients with upcoming appointments that might be eligible based upon age and being a current smoker. And then they get contacted with our quit line folks, here at Anderson, and we deliver the counseling and share decision-making visit, in addition to the cessation, and we give a report back to the BCP. And well, we're hoping that increases individuals to get screened and also have proper follow up, if there is something abnormal on the scan.

So I'm curious if you have any other suggestions outside of your program of ways we might improve the uptake of lung cancer screening in the US.

Oh, I think we could do a number of things. So I think we have to think about each step of the pathway. Right? So one, we have to increase awareness of it. So that's through social media, social marketing, that kind of stuff for both patients and providers and caregivers.

Then, two, we need multiple avenues, where we talk about lung cancer screening, like how we do with breast cancer and colon cancer. Like at church, at your beauty parlor, at your grocery store, and have those kind of public health interventions to get out the information. And three, we really need to train up our health care workforce and help programs. Where it's possible to either have the PCP do it in a robust manner or have a more linked program, where they can refer to a centralized program. Where the counseling and shared decision-making visit can be delivered by their pulmonology or in the radiology scan, and the patient can get scanned that day.

So I think there's a lot of different questions and different delivery models that can be asked, and this is a great area to be working in right now. Because with the release of the Nelson study, it's even more exciting to show that lung cancer screening can be very beneficial, and with using the lung rads, the false positives are much lower. So I'm pretty excited, and I think there's so much opportunity, and we can learn so much from what we're doing in breast cancer and colorectal cancer screening.

No, I completely agree with you. I think it's very exciting that the Nelson study was finally just published, and so hopefully, this will overcome any residual skepticism about the benefits of lung cancer screening. And obviously, continuing to improve on the screening tools themselves, maybe using some kind of companion diagnostic, maybe blood or breath-related, that might improve the-- or using artificial intelligence to better tell benign from malignant nodules. Ways that you can reduce the false positive rates would be very helpful. Well, Dr. Lowenstein, thank you so much for joining me on the podcast today.

Thank you. It's a pleasure.

Until next time, thank you all for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts, Google Play, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode.

JCO OP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper will be available online at ascopubs.org/journal/op, in February, 2020. This is Dr. Nate Pennell for JCO Oncology Practice signing off.

Dr. Nathan Pennell, Dr. Muhammed Beg and Ms. Erin Williams discuss improving the time-to-activation of new clinical trials at an NCI-Designated Comprehensive Cancer Center.

Read the article: https://ascopubs.org/doi/full/10.1200/OP.19.00325

TRANSCRIPT

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DR. PENNELL: Welcome to the latest Journal of Oncology Practice podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, I'd like to talk about clinical trials, specifically the complex process that goes into opening a clinical trial and the surprising amount of time and individual steps that go into what might otherwise seem like a straightforward process. And while we all agree that trials are critically important for patient care and making scientific advances, as a clinical investigator, I can tell you that they can be quite a challenge to open and sometimes take a surprising amount of time and resources, which can be frustrating.

With me today to discuss this topic are Dr. Shaalan Beg, associate professor of medicine in the division of hematology and oncology at the University of Texas Southwestern Cancer Center, and Ms. Erin Williams, associate director of clinical research operations at the Simmons Comprehensive Cancer Center. We'll be discussing their paper, "Improving the Time to Activation of New Clinical Trials at an NCI-Designated Comprehensive Cancer Center," to be published in the November 2019 JOP.

Welcome, Shaalan and Erin, and thank you for joining me on the podcast.

DR. BEG: Thanks for having us.

DR. PENNELL: So can we start off by talking a little bit about what's involved in the clinical trial opening process and why this ends up being such an important issue that leads to projects, like what you describe in your paper?

DR. BEG: Yes. It's a pretty complicated process. And I think I say it a lot, like, how a bill becomes a law. So how does a trial protocol become an open clinical trial available to our patients? So when you have a document which embodies the principles for the clinical trial or the clinical trial protocol, you have a consent form that will be a patient-facing document that the patient sees, which summarizes, in layperson's terms, what the procedures will be for the study. And then these documents have to go through multiple steps of approval within individual institutions.

For example, the institution review board will look at the document in terms of risk management or risk assessment for the institution. Scientific committee will review the scientific integrity and see whether it suits the patients that that specific center is taking care of. And then, in parallel, you have a group of experts who want to see if that trial is something which they can feasibly execute. So hypothetically speaking, if a trial needs treadmill tests, do we have a treadmill to actually do that? So really the rudimentary, sometimes, feasibility questions.

And then, as the studies are becoming more complicated, some of these studies have biomarkers which we want to identify patients for, and we need to test patients before we can find the right patients for the clinical trial. So that entire process is becoming more and more complicated.

DR. PENNELL: That all sounds like it makes perfect sense, but I know a lot of our listeners might be surprised to learn that this entire process from beginning to end can take a long time-- sometimes six months or longer. What are the consequences to an institution of taking a long time to activate a trial?

MS. WILLIAMS: So this is Erin. Well, the consequences can mean our access to clinical trials, right? So it can also mean access for patients to the clinical trials. So both of those things. If we take too long to open the study and a lot of other centers around the country or around the world have a study open-- and specifically, there are a lot of trials that are open internationally, and sometimes it's easier to open trials internationally more quickly-- then our patients lose access to those trials as the spots for enrollment fill up and the study goes closer and closer to its enrollment target.

But in addition, sponsors, industry sponsors, pharmaceutical companies that are bringing trials to their cooperative groups in which we participate-- these are NCI-funded large-cluster groups for phase III clinical trials, we participate with those as well-- they're looking at how long it takes us, as an institution, to activate a new study. And if we start to take longer than most other institutions, they may not favor us for a particular trial to offer that trial to us.

DR. PENNELL: This is such an important process, and I think this is really going to resonate with lots of people who work at centers that open clinical trials. So why don't you take us through the process? So what exactly did you do there?

MS. WILLIAMS: So this is Erin again. We convened a group of stakeholders, along with a leader from our institution's Lean Six Sigma program, to really map out the process. So we convene about four or five hours of a day for everyone to come in. And it didn't just include cancer center stakeholders, but it included stakeholders from our sponsored programs administration office at the institution, our institutional review board, human research protections office, our hospital review committee. We really wanted to gather together all those people who touch the process in some way throughout the course of the time to activation.

And so really with Patrice's help, who is our Lean Six Sigma expert, she really kind of started the process out, and we did kind of what your traditional Lean Six Sigma mapping might look like-- use sticky notes and words on sticky notes, mapping out the process on the long board, and then ultimately creating what the map looks like. And I think what it did was allowed everyone who was in the room to really take a look at the process and how sequential everything came out to look.

One of the biggest impacts that we identified and that we highlighted in the paper is what you really saw was this gap between our scientific review committee submission and the IRB review, and then everything else in the process, because a lot of steps hung on IRB approval and didn't want to move forward, including hospital review, contract execution, things like that, until the IRB had given their stamp of approval, which of course is the review board for patient safety.

So what we tried to do is, immediately, you could kind of see this visible gap in-between the steps, and that really showed us that potentially aligning that scientific committee review with the IRB review and allowing that IRB approval to happen more quickly might trigger some of the other steps.

DR. PENNELL: One of the things that I found really interesting when you were talking about the various steps in the process was when you chose to start the clock, because I know that there is a lot of attention paid to how long it takes to open trials. And, you know, in my experience, I have heard that there are institutions that somewhat game their numbers by not starting their clock to opening until they've actually gotten a lot of steps already done before they do, say, a regulatory submission. And then it looks as though they're opening the trials quite quickly, but they may have already had the protocol for many months ahead of time, working on things ahead of this.

And you guys chose to start from the time you actually receive the regulatory packet and the protocol to start, which makes sense. I mean, that's really when, I think, you, as an investigator, would think the clock would start. But did you ever get any pushback from your leadership or others to starting that early?

DR. BEG: No. I think it's a matter of being consistent with how we report our numbers. Similar to you, we are an NCI-designated center. We report these to our advisory boards and to the NCI in regular intervals.

I think whenever we're measuring numbers and we set metrics for any target, we run the risk of people trying to cut corners and gaming the system to make the number look good. I think that's pretty well-documented in any industry. And our time-to-trial activation has become this shared quality metric across the cancer center, across the institution. And we were worried that it may start being that way, that folks are trying to, "well, should we take out the weekends, those aren't really work days, or how about the time the sponsor has the packet, or--," you know?

And I think, as humans, we all have tendencies to try and come up with ways to make our numbers look better. But the advantage of publishing this to a journal like the JOP with transparency on how we're measuring it, and, you know, I think we had faith that our audience would recognize when our time is-- when our time clock is starting. And there wasn't any pushback.

MS. WILLIAMS: I'll just add to that. The reason why I think it's so important to be transparent with these numbers is because-- being in an administrative role and an operational in a clinical research office for a long time, investigators who are bringing a trial forward for us to activate, the calendar has started as soon as they bring me a trial that they want to open. And if I tell them that a study only took 60 days to open, and their recollection is nothing near what I'm telling them my metric is, then they're not really going to trust what I'm telling them overall. And I think it's important that I recognize, and that we recognize as an operation, that what really matters is that once we get the study, we're starting the process.

It just makes the numbers more useful to you, internally. It makes it more useful to the outside companies or organizations that you're working with. And, you know, even the non-value added time that's not in your control can sometimes-- you can intervene in that. You could potentially escalate things if you haven't heard from a company in a certain period of time. So I completely agree. That makes perfect sense.

DR. PENNELL: So, well, why don't we dig into your results? So what did you find through the mapping process?

DR. BEG: I think one of the issues was how we can move some of the steps that happened in parallel or that happened sequentially to try and make them work in parallel. And like Erin mentioned earlier, just mapping out the process and having the different offices represented on campus that are a couple blocks away from each other really think about how they-- when they start their clocks and why they wait for specific milestones to start a review process was very helpful.

So one of the steps was to really move from a sequential process of scientific review followed by an institution review board review into a process where we move that in parallel to each other. And different centers have grappled with this question in different ways. The way we decided to address this, we didn't want the IRB to be bogged down by a study that wasn't scientifically valid, that may have concerns, or is not novel enough. But we have internal data that our scientific review committee-- and this is published data-- that our scientific review committee very rarely changes the design or the structure of an industry-sponsored clinical trial, for example.

So we decided that we would come up with a process where the IRB will physically review the study at a time after the scientific committee has reviewed the study. If the study is disproved, then it falls off the IRB's docket. But if it's approved, then they will be ready to review it. And we were able to shrink that time from scientific review to IRB quite significantly by modifying that process.

We talked about institutional studies, so studies that our own investigators are developing. Those studies do tend to get more criticism at the scientific review committee. Our committees review them much more closely and have much more impact on those. And we decided to move them forward on a case-by-case basis. So it really required some restructuring.

MS. WILLIAMS: One of the other things that we outlined in the paper, one of the other outcomes, was that our hospital review committee agreed to review the study in parallel with the IRB and in the PRMC review process and just hold their approval until those approvals had been received. And that happened. And if you looked at the individual time to getting that hospital review committee approval immediately following the intervention, it went down significantly.

As with anything, it takes consent kind of massaging and working with those groups. And some of the offices and the infrastructure around clinical trial changed subsequent after we had our time to activation. And so with any of that change, processes start over, people start looking at things over again, and they decide, well, wait, why are we reviewing this in parallel? Or these other groups of people need to be reviewing this in more detail.

Having said that, as those processes have changed, what we've heard and what we've experienced with those stakeholders in the institution is that their eye is always on the activation timeline. And that if we report to them, hey, this time to review committee approval has kind of gone back up, it's creeped back, and we really need to look at this again, you can see their immediate response is, oh, absolutely, we understand, these are kind of some shifts that we made, but let's get together, let's look at it, we really are hoping to push it back down.

DR. PENNELL: Well, I think that's a great point to point out, that this is not a one-time thing. And whatever changes you institute, you can't just do it once and then expect it to be a permanent change if you don't follow up and ensure that it's still working.

DR. BEG: One of the other things which came up when we were looking at our numbers was to figure out how to staff different positions. And there are some steps of the activation process that are very nuanced, really require special expertise. And an example for that is the coverage analysis evaluation, where a third party independent of the investigator's team decides whether every procedure or blood test or scan gets billed to insurance or is that something that gets billed to the study. So is it a research procedure or is it a standard of care procedure? And in oncology, where philosophically we view research as embedded within standard of care, that can be a pretty tricky determination to make.

So the people who do this come in with a really unique set of expertise from their clinical-- that have clinical expertise and research expertise. And one of the things we noticed was for positions like those and for positions other than that, it's really important to have redundancies in those positions, so if there is staff turnover of any kind, that that process can keep moving forward. Because those are steps that-- it's hard for a consultant to come in and fill in and those people don't really just hang out on campus for us to be able to tap their time and to start processing those studies.

So other than looking at our processes, it did come down to staffing those positions and making sure that we create some redundancies in those positions so that we're not completely dependent on, for example, one person for a task like that.

DR. PENNELL: And that is such an obvious issue that I think maybe a lot of people may be shocked to hear that institution's administrations don't always agree that you need more than one person to do a task. But again, this is really resonating with me personally, because we went through this same issue. And there are so many important things that for some reason there's always just one person who can do it. And if they're out for whatever reason, or they leave and there's staff turnover, things just grind completely to a halt. And so I think that that's a wonderful illustration that hopefully will be convincing.

Did all of this work end up making a difference in your time to opening trials?

MS. WILLIAMS: It is making a difference. We are seeing improvements in certain steps of the process. We've definitely seen an improvement in our time to both scientific committee review approval, our time to IRB approval. Our coverage analysis timeline has been very steady. Our time to activation for our national cooperative group studies has been very stable at around 90 to 100 days, since instituting just kind of these simple-- well, not so simple-- but since instituting this whole process.

Where we still have challenges is in our budgeting and contracting process. However, again, since we've got that institutional buy-in, it was actually our sponsored programs administration office contract director who approached me about two or three months ago and said, you know what, we really need to talk about the workflows between covered analysis, budget negotiation, and contract, because I see things kind of being an issue for us, as far as getting expedited approval and execution of contracts.

So we had another about 2 and 1/2 hour meeting just about a month ago to sit down and go through that workflow and identified, again, a couple of key places where we can bring previously sequential steps into a parallel-step process.

And so once again, I think the take-home of the exercise that we performed is that we have institutional stakeholders who aren't necessarily just waiting to hear from us to figure out how we can do better, but are coming to us and identifying timelines and being able to work together to continue to make those happen.

DR. PENNELL: And it sounds like this has worked very well for your institution. But you point out in your manuscript that a lot of the processes are so unique to individual institutions that it's hard to make blanket recommendations that apply everywhere. So what can other sites who are also worried about their time to activation take from your process?

DR. BEG: I think one message is to know what your internal process is. And I think a lot of folks who are listening to this podcast will admit that at their centers there's no one document that really maps out the entire process. So for us, the process of mapping out the trial activation process was probably the most transformative bit, the rest sort of just fell into place.

DR. PENNELL: Shaalan and Erin, thank you so much for joining me on the podcast today.

DR. BEG: Thank you very much.

MS. WILLIAMS: Thank you.

DR. PENNELL: Until next time, thank you for listening to this Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JOP's podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper will be available online at ascopubs.org/journal/jop in November 2019.

This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

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Dr. Nate Pennell talks with Dr. Joel Segel about "Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients."

Article available online at Journal of Oncology Practice.

TRANSCRIPT

Support for Journal of Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at astrazeneca.us.com.

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Welcome to the latest Journal of Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor at the JOP.

Medical care can be very expensive in the United States. And a diagnosis of cancer can be a huge shock, both physically, mentally and financially. Medical expenses don't just impact financial lives, but may also impact treatment outcomes, as even patients who are cured of their cancer may be left with a significant amount of debt.

One of the primary goals of the Affordable Care Act-- so-called Obamacare-- was to increase the number of citizens covered by health insurance, so that these financial burdens would be lessened. And we know that as the result of the Affordable Care Act, overall insurance coverage did increase. But how well did this work for patients with cancer specifically? And what impact has it had on financial burdens?

With me today to discuss these issues is Dr. Joel Segel, assistant professor of health policy and administration at the Penn State University. We'll be discussing his paper, Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients, to be published in the October 2019 JOP. Welcome Dr. Segel. And thanks for joining me today.

Thank you for having me.

So can you start, for our audience, just by putting the general landscape into perspective for us. What are the financial burdens that cancer patients go through, especially those who are in lower incomes?

Sure. So there's certainly been a lot of evidence that cancer patients face, obviously, a number of medical care and health burdens, but also financial burdens. And in some cases, the financial burden can be pretty significant.

We also know that certain groups are probably disproportionately affected. So we know lower income, especially sort of racial and ethnic minorities, and especially some of the younger cancer patients can face significant financial burdens, but it also varies quite a bit. And so the evidence is certainly mixed in terms of how it's measured, how a financial burden is experienced by these different patients, but it can be as extreme that there is evidence that 2% to 3% can experience financial bankruptcy. So these can be pretty significant financial burdens.

And I guess the last thing would be there's probably two ways in which a patient can face a significant financial burden. So one is, and the one that we actually focus on most in our paper will be, the financial burden that results from medical care costs. We can also think about that, obviously, cancer can affect an individual's ability to work. So there can also be an additional financial burden if they're unable to work or they have to cut back on their hours, and that leads to a reduction in their income.

And is there evidence that patients' insurance status factors into their financial strain and burden?

Yes, there's certainly evidence that patients that have more comprehensive coverage, especially those that are higher income, that may help to mitigate much of the financial burden, whereas patients-- and that's one reason why younger patients sometimes have less comprehensive coverage. And they also may have less in savings and be less prepared to deal with some of the financial burdens.

And I think that makes perfect sense. And so what was in the Affordable Care Act that was designed to help patients deal with this?

The Affordable Care Act is an extensive law with a whole bunch of different features. I think there are several that are probably particularly relevant for cancer patients. So one is the one that's probably talked about a lot, which is the Medicaid Expansion. So initially, states were required to expand Medicaid. Due to a Supreme Court case, it became optional. So certain states decided to expand Medicaid, and that meant that they expanded who would be eligible. So primarily lower income adults, particularly ones without children, became eligible for Medicaid in certain states. So that's one piece.

I think the other one that's come up a lot, especially in a lot of the news stories, would be the restrictions on preexisting conditions. So certainly leading up to the Affordable Care Act, one major concern was that individuals, particularly-- cancer was one of the prominent examples would be if they had previously been diagnosed with cancer, they might have trouble either obtaining health insurance coverage or being renewed for health insurance coverage. So the Affordable Care Act made it so that regardless of what health care conditions an individual had, they were guaranteed renewability of the health insurance or the ability to purchase a health insurance plan.

And I think the last two general sections that might also affect cancer patients would be, one, they set up a number of state-based health insurance exchanges to allow individuals to purchase health insurance, and particularly for individuals who are buying individual plans and not through their employer, prior to the Affordable Care Act, especially for those with cancer, might have had difficulty purchasing a health insurance plan. So these state-based exchanges were an opportunity for individuals to purchase health insurance, and depending on their income with subsidies. So there were both subsidies for the premiums, or what an individual would pay each month for their health insurance plan, as well as cost-sharing subsidies. So for lower income individuals, they could become eligible for additional assistance to help cover some of their medical care costs.

And then, I guess, the last part would be that the Affordable Care Act placed limits on what an individual would have to pay out of pocket, both in terms of within a given year, and also, they got rid of some of the lifetime limits to health insurance.

OK. So it's obviously a complex law with a lot going on. But fundamentally, ultimately, the hope was that more people would be insured and that fewer people would suffer the consequences of having to pay for expensive medical care without having the insurance to help them with that.

So with that now put into perspective, take us through your study. How did you design this? And what were you hoping to look for?

So what we wanted to do was to take a look at, in particular, the non-elderly population who had been diagnosed with cancer. So what we did is we took a look at a large nationally representative data set, the Medical Expenditure Panel Survey, which follows a random sample of individuals across the United States for a period of two years. And within that, we then try to identify a non-elderly-- and by non-elderly, that'd be ages 18 to 64-- who had been previously diagnosed with cancer, or who, in the data, we could observe that they had some utilization for which there was a diagnosis of cancer.

And we then further restricted it, for much of our sample, to the lower income population. So that would be individuals who lived in a family that was at less than 400% of the federal poverty level. I guess to give a bit of a sense of that, that would be about $48,000 for an individual or $100,000 for a family of four currently. And we specifically chose that threshold, because that's the threshold by which individuals qualify for premium subsidies on the state-based exchange.

In particular, what we're going to look at is, first, we're going to look at coverage, so the number of months an individual spent either uninsured with Medicaid coverage or with private coverage. Among those with private coverage, we also took a look at whether they were enrolled in a high deductible health plan. We also looked at spending in terms of both their overall spending and also their out of pocket spending. And then, finally, to get a better sense of some of the financial burdens that families might face, we looked at both the change in what this family had to pay out of pocket for their health insurance premiums, so just the part that the family or individual pays as well as the fraction that a family pays for their health care costs, and that would be both the medical costs as well as the out of pocket premium.

And our last one, in addition to the fraction of income spent, would be whether they crossed a threshold of 20% of their family income spent on health care costs, which is a commonly used measure of high medical burden.

OK. So I think that makes sense focusing on that group. So what did you find?

So we look at a couple of different samples, both the lower income cancer population as well as the higher income cancer population. And we look at sort of how those outcomes changed from before the Affordable Care Act to after the Affordable Care Act. And in addition, we were going to make some comparisons to try to get a better sense of whether these changes looked different for different groups, so whether the higher income cancer group, how do they compare to the lower income cancer group, how the different cancer groups might compare to a population with a similar income level, but without cancer.

Similar to other studies, we see a significant improvement in health insurance coverage among the low income or the lower income sample with cancer. We find that that's driven largely by both an increase in Medicaid coverage as well as an increase in the high deductible health plans. So people seem to be enrolling in either Medicaid or private coverage, and that tends to be with some of the higher deductible health care plans. We see similar changes for individuals who what we'll call current cancer, and those are the ones who not only have been diagnosed with cancer, but show some utilization in the current year.

And then, I guess, in addition, what we find, we find something slightly different in the higher income cancer sample, and that's that they also experience an increase in the enrollment in high deductible health plans, but they also see a significant increase in their out of pocket premiums as well as the fraction of family income spent on health care. And so that's what we see in terms of just comparing pre and post. But we also do a number of comparison to some different groups to try to tease out sort of what might be driving, and sort of how similar the cancer population might look in terms of their improvements to some of the other population.

You mentioned that a lot of this had to do with the expansion of Medicaid, but of course, that that was rather sporadic because not every state expanded Medicaid. Did you look regionally at these numbers or is this basically nationwide?

So it's nationwide. In some of our adjusted analyses, we're able to control for region. But actually, one of the limitations of our study is that in the data that we have available, we can't identify an individual's state. So we don't know whether or not they're necessarily in an expansion state or a non-expansion state.

Yeah, because one of the first things that occurs to me is that if everyone had expanded, would the number be larger? And is there any evidence of the Affordable Care Act improving coverage and financial burdens specifically in states that didn't expand Medicaid? But I think that would be an interesting thing to look at maybe in the future.

Absolutely, and there's certainly some evidence to suggest that within cancer populations, generally, there does seem to be improved health insurance coverage, in particular, in some of the Medicaid Expansion states precisely for the reasons that, I think, you're mentioning.

One of the other things you looked at is you looked at a comparison group with a higher income level, what did you find in that group sure so one of the comparisons we make is that some changes in our outcomes between the lower income cancer sample and the higher income cancer sample what we see is maybe not surprisingly there's less of a change in health insurance coverage among the higher income cancer sample part of that is that they've had they had higher coverage rates to begin with. But what we also see is an increase in the out-of-pocket premium of about $800 per year for the higher income sample relative to the lower income sample. And we also see it relative to lower income sample that day they experience about a two to three percentage point increase in the fraction of their income spent on health care costs. What we find seems to be driving that is actually

more of a modest increase in the fraction spent among the higher income cancer sample along with sort of a very modest decrease in the lower income sample where are you going to go from here with these data what future studies do you have planned and what ideas can you pull from this to try to help reduce future financial burdens on cancer patients. So part of it is trying to get access to some of the restricted data where we would actually be able to identify what state people are and so we could get a much better sense of whether we're seeing some of these changes differentially in expansion states versus non-expansion states.

Also, with some additional restricted data, we'd able to get a better sense of how these patients might be transitioning across different types of health insurance plans once they're diagnosed with cancer. So right now, we've got a mix in terms of patients who are in active treatment and more recently diagnosed, along with patients who may have been diagnosed further back. I mean, unfortunately, in the data we currently had, we're not able to accurately distinguish exactly when they were diagnosed. But again, we'd be able to better tease out some of those differences between people who had maybe been diagnosed longer ago versus more recently.

So one of the things that everyone is worried about today, of course, is the rapidly rising cost of medical care, especially drugs in patients with cancer. That probably poses a challenge to doing this kind of research showing pre and post expenses when the actual cost of care is going up during the study period.

It's certainly an important thing to consider. Obviously, during this time period, the cost of, in particular, some of the cancer therapies has gone up significantly. We try to account for it, I guess, in a couple of different ways. One was going to be we're comparing some of the higher income and the lower income populations to get a sense of whether they differentially experience some of the financial burden. So to the extent that both lower income and higher income cancer patients are facing the same increase in drug prices, we would control for that to some extent.

I guess the other comparison we made was to compare, in particular, the lower income cancer sample to a lower income sample that did not have cancer. And actually, interestingly, what we find is we don't really find much of a significant difference between those two samples. So what that suggests is that the Affordable Care Act improves coverage and may help to mitigate some of the financial burden, but it does similarly for both cancer and non-cancer patients who are low income.

And that makes sense. As much as we pay attention to cancer because that's our field, it's only one of major health issues. Especially in a non-Medicare age population, I would think there'd be a lot of other competing risks. But still, it sounds like that is a good control over the overall rising costs of health care.

Well, Dr. Segel, thanks so much for joining me for the podcast today.

Thank you for having me.

Until next time, thank our listeners as well for listening to the Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode.

JOP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper will be available online at ascopubs.org/journal/jop in October 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Nate Pennell discusses "How to Know if a Somatic Tumor Mutation is Targetable" with Suanna Bruinooge, the director of research, strategy, and operations at ASCO's Center for Research and Analytics, or CENTRA, and Dr. Richard Schilsky, senior vice president and chief medical officer at ASCO.

Read the related article "Determining If a Somatic Tumor Mutation Is Targetable and Options for Accessing Targeted Therapies."

[DR. NATHAN PENNELL]

Welcome to the latest Journal of Oncology Practice Podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, I want to talk to you about an increasingly common scenario encountered in clinical practice. Molecular testing for biomarkers to help guide treatment of patients has now become a standard part of treatment for many types of cancer. For example, HER2 testing and breast cancer or EGFR mutation testing in lung cancer.

But testing is also increasing in other cancer types often using broad, multiplex assays surveying hundreds of genes. Clinicians are being presented with a report that may seem dauntingly complex and hard to interpret. And even when you have a drug recommended, that may be off-label for its use or even experimental, leaving patients and clinicians perplexed as to how to access them.

With me today to discuss these issues are Suanna Bruinooge, the director of research, strategy, and operations at ASCO's Center for Research and Analytics, or CENTRA, and Dr. Richard Schilsky, senior vice president and chief medical officer at ASCO.

We'll be discussing their paper, "How to Know if a Somatic Tumor Mutation is Targetable-- Options for Accessing Targeted Therapies" published in the August 2019 JOP. Welcome Suanna and Rich, and thanks for joining me today.

[DR. RICHARD SCHILSKY]

Thanks for having us, Nate.

[SUANNA BRUINOOGE]

Thanks.

[DR. NATHAN PENNELL]

So Rich, give me a little background on the problem that you were hoping to address with this paper. Why did ASCO feel it was important to provide a guidance to oncologists about interpreting testing reports and accessing these drugs?

[DR. RICHARD SCHILSKY]

Well, I think you actually framed the problem very well in your introduction. Obviously there's a lot of tumor genomic profiling that's going on these days, oftentimes for very good reason to identify actionable alterations that are known targets of effective anti-cancer therapies.

And what we've been seeing, of course, in more recent years is the more widespread use of genomic profiling, oftentimes for people who have advanced cancer, who no longer have any standard treatment options available. And the physician is looking to see whether or not there's something that might be considered actionable in the tumor genome that could provide a therapy option that wasn't considered.

We're also seeing that the testing itself has become much more expansive. So instead of testing for a few genes, many tests are now testing for hundreds of genes. And, of course, they can be many different alterations that could occur within any given gene. So the amount of information that's being provided to oncologists in these test reports is enormous and very difficult to interpret.
The nomenclature is difficult to understand. The biological relevance of the alterations is difficult to understand. And whether or not they really lead to a potential course of therapy is oftentimes difficult to figure out, because a lot of what turns up in the reports is difficult to understand and difficult to interpret.

So one of our goals in putting this short paper together was to try to provide resources to oncologists to help them navigate these test reports to help them have resources available to, in essence, look up the abnormalities that are being detected and try to figure out whether or not that's something that might be targetable with a particular drug. And then, of course, secondarily as you pointed out, to help walk them through the various strategies they can use to actually obtain the drug that seems like it might be a good choice for their patient.

[DR. NATHAN PENNELL]

So if I'm looking at one of these reports now and seeing these alterations, how do I decide if that truly is actionable or not? And how do we decide what level of actionability, whether this is something that's really a standard of care now or something that's much more lower level of evidence?

[DR. RICHARD SCHILSKY]

Yeah, it's a great question. So, I mean, there are actually some conventions regarding the level of evidence to assign to genomic alteration to determine its actionability. And in fact, ASCO working together with the College of American Pathologists and the Association of Molecular Pathology published a paper a couple of years ago, now, sort of assigning levels of evidence.

But the convention goes something like this-- if the alteration is the target of an FDA-approved drug, then that's a high level of evidence that the alteration is of clinical importance. It may or may not be of the same level of importance in a histology that is outside of the FDA-approved indication for the drug.

Best known example that is often described as BRAF mutations in patients with colorectal cancer, which do not respond nearly as well to BRAF inhibitors, as the same mutations respond when they occur in patients with melanoma. But nevertheless, a BRAF mutation occurring outside of the melanoma indication has still might be considered to be sort of level two evidence of potential actionability.
Then as you get further and further away from FDA-approved therapies or FDA-approved indications, then you get into lower levels of evidence. So you have, as you mentioned earlier, variants of unknown significance. These generally are alterations that are detected in the genome that truly are of unknown significance.
They have not been well-characterized. It's not clear what their biological relevance is with respect to being related to tumor initiation or progression. It's not clear whether they represent markers of response or resistance to therapy. They're just alterations where really more research is necessary to determine their actionability.

Nevertheless, I can tell you that we often find that many physicians think that it might be worthwhile to target APUS sort of just to give something a try. Then at the lowest level of actionability are the germline alterations. Now, even there, it's complicated because, of course, there are some germline alterations that actually direct you to use an FDA-approved drug, like germline BRCA mutations used to direct therapy with PARP inhibitors.

But generally speaking, germline alterations or alterations that have been well characterized and known to be functionally benign, there, the evidence for actionability would be considered to be very low.

[DR. NATHAN PENNELL]

I've certainly seen people treated with targeted drugs for variants of unknown significance and, otherwise, actionable genes, such as EGFR mutations but well outside the tyrosine kinase domain. And it really depends a lot on how well it's presented in these reports as to how easy it is to figure out what's actionable and what's not.

[DR. RICHARD SCHILSKY]

Well, that's right. And one of the reasons we included in the paper that quite expansive table of knowledge bases that are available is to help oncologists help participants who have elected a tumor board determine where to go to look up an alteration that might actually give them useful information as to, has it ever been reported before in human cancer?

If so, is it an alteration that is likely to be biological significance based upon the nature of the alteration and where it's located in the DNA? How close it is to other known ontogenic alterations and so on. So hopefully, readers of the article will find one or more of those knowledge bases' valuable resources, particularly in the context of a molecular tumor board discussion.

[DR. NATHAN PENNELL]

Absolutely. This is a fantastic resource. And I've got a couple of these bookmarked on my own desktop so that I can look things up, such as mycancergenome.org, for example. So I think our readers hopefully will check into that. So now that we have identified an actionable alteration, and we have a recommendation for a particular drug, what are our options for going about accessing these drugs for our patients?

[SUANNA BRUINOOGE]

Thanks, Nathan. This is a really good question. And I think we created a figure in the manuscript to really help clinicians and patients walk through what the options are laid out in front of them. And as you can see from the figure, it really does depend on the initial question being, does the targeted drug have FDA approval?
And as Dr. Schilsky mentioned earlier, it may depend on whether the indications specifically include the cancer type or histology that your patient has. But let's just say, then that case, it would be considered an on-label indication, and largely be reimbursed by insurers.

But let's say, the indication-- the cancer type is not specifically mentioned in the label. In that case, it would be considered an off-label indication. And so in that situation, there is a chance that the company or other researchers are already looking at whether the drug works for that same alteration and other cancer type. In other words, research on off-label indication.

And in these situations, as trials have been completed and results are published, they might be noted in either clinical pathways or drug compendia. Or it might be published in scientific journals, like the Journal of Clinical Oncology and Journal of Oncology Practice.
So in those situations where there is published data, and that supports the use in a different cancer type, then, you might be in a situation where Medicare or private payers might provide coverage for that off-label use. So in those situations, contacting the insurance companies is what we reference in the article to obtain authorization to prescribe the medication and get coverage.

In situations where there isn't published data, there might be clinical trials that are under way. And in those situations, obviously, the clinical trial-- you'd have to look at the eligibility criteria for the clinical trial. Is it something that's available at your clinic? If it's not available at your clinic, is it something that the patient could travel to obtain enrollment in the clinical trial?

So that's really on all along that left side of the figure related to whether the cancer type is mentioned on the drug label, whether there's published data. And the payer might cover it off-label, or if the patient would qualify for a clinical trial. If none of those are a possibility, then there still might be an occasion in which the patient would still be interested in accessing the therapy. And then you might want to look into financial assistance options for the patient. And in the manuscript, we talk about, there's recently been a compilation of patient assistance programs. And we include the website in our manuscript. And that does allow a clinician and a patient to look across multiple pharmaceutical companies to see if there might be patient assistance options available if it's already an FDA-approved approved drug.

[DR. NATHAN PENNELL]

Oh, that's great. So what about for patients who want to access drugs, but for whatever reason, don't have either an approval for off-label use, or there's no trial available? How would patients access drugs in that setting?

[SUANNA BRUINOOGE]

In that setting, you're probably thinking about a drug that's an investigational use if it does not have an FDA approval. And in this situation, there certainly may be circumstances in which a clinical trial isn't available. Or maybe your patient is not available at your site. Or maybe your patient doesn't qualify and meet the eligibility criteria or isn't able to travel for the clinical trial.

And in those situations, there may be options that you and your patient could explore through something called expanded access program. And there's really three options that are sort of broadly described as expanded access program. A company might offer a large or mid-sized expanded access program.

It's essentially like a clinical trial, although it may be collecting less data in the course of the clinical trial. It might be for a broader patient population who might not otherwise qualify for the clinical trial. And typically the company might conduct this as a broader access for patients who don't qualify for a clinical trial.

Or perhaps in the interim period between which a company submits its application to the FDA, and they're waiting to hear about the FDA review of the drugs. So these are often sort of in that interim time period before a drug might be approved.

The third type of expanded access program is an individual patient use. And this is something that is there's actually new resources that are available on a couple of different locations. There's an organization called the Reagan Udall Foundation. So that's Reagan as in the former president. And Udall-- U-D-A-L-L.

This is a foundation that supports the work of the FDA in a broad sense. And they have something that's called the Expanded Access Navigator Program that's available on their website. You are a patient Google Expanded Access Navigator. The Reagan Udall website will certainly become available in the listing.

And what this does is list all the companies that provide expanded access program. So this is a good starting point to see if a company might be offering either a large or midsize expanded access programs and also list the company context at the company so you can also figure out how to contact the company to find out if your patient qualifies.

If there isn't a program. Then fortunately, in oncology, we also have another option that clinicians can explore. The FDA Oncology Center of Excellence recently launched a program that's called Project Facilitate. And this provides both web-based resources, as well as a phone line that is available during business hours which are largely East Coast business hours.

And it's a resource for clinicians to contact related to individual patient access requests. And the FDA has staff who are very knowledgeable about the individual patient access pathway. They can help with contacting companies and sort of serve as an intermediary to help navigate those situations.

And the FDA role is actually in any of these three expanded access programs. The FDA plays a very important role in reviewing requests from clinicians. And they provide sort of a third-party review of the circumstances. And they're very quick to respond to inquiries in this regard and really do approve virtually all of the requests for access that they receive.

And so long as the company provides access to the drug, ultimately, the decision about whether to provide access to the drug is up to the company.

There is another avenue, which is described in our manuscript as well. Some states have also passed right-to-try laws. In these circumstances, these laws are at the state level. So not all states have passed them. But they provide a pathway that bypasses FDA review and assessment. They do not require that a company provide the investigational drug. So that circumstance is really still up to the individual company, whether they want to make the drug available outside of clinical trials.

[DR. NATHAN PENNELL]

I think a couple incredibly important things that I want to make sure everybody got out of this. One is that all of this relies on the pharmaceutical company actually being willing to provide these drugs. So even the right-to-try laws on the state and federal level don't require that the companies give access to the drugs to the patient. So both of those are necessary.

And second of all, that the FDA is incredibly helpful in providing access to these drugs. I've personally gone several times through compassionate use single patient's drug access through the FDA. And they've been tremendously helpful and never were in any way a barrier to getting access to the drug. They're fast and responsive.

And so I actually haven't personally heard much in terms of the use of the right-to-try laws to access drugs. I don't know if that's something that there was a lot of attention, of course, when the federal government passed the law. But I haven't heard much about it since then.

[DR. RICHARD SCHILSKY]

Nor have we. I don't think we're aware of any circumstances in oncology where patients have access to investigational drugs through the right-to-try pathway. That may be because the companies are reluctant to make drugs available. Or it may be because appropriate drugs just haven't been on the radar screen.
I think all of us, though, would agree that a much better way of providing access to drugs would be to do it in a way where you're actually collecting the information on the efficacy of the drugs and the toxicity of the drugs where you can learn about that process and help lead to an eventual approval. So what is ASCO doing that can help provide access to promising drugs, perhaps, an off-label setting for patients?

Many people know the TAPUR is an acronym that stands for Targeted Agents and Profiling Utilization Registry. So it's a quite a mouthful. And so we like to call it TAPUR. So TAPUR is a prospective multi-arm phase II basket trial, which is matching commercially available targeted drugs used to off-label against a genomic alteration in a patient's tumor.

So, in essence, we set up TAPUR to be able to learn from the off-label prescribing of targeted drugs to patients who have advanced cancers. And the study has been ongoing now since March of 2016. There are about 1,600 patients who have been enrolled at about 120 sites around the country.

We've started to report out both negative and positive results. And we think that negative and positive results are equally important in this setting, because, for example, if a doctor could prescribe a drug off-label, but there's no evidence that the drug actually is beneficial, then those patients are better served by being directed to other clinical trials.

So for example, last year, we reported that palbociclib is not effective in either pancreatic or biliary tract cancers that have a CDKN2A alteration. So the implication being, of course, that the next time a doctor sees that alteration showing up on a tumor genomic test report for a patient with one of those cancers, they probably should look for something other than palbociclib.

Now, alternatively, we've also begun to identify signals of activity that either have been already reported in more formal clinical trials. And we're just able to affirm that the therapy works in a more real world population or in some cases haven't really yet been identified.
So, for example, at this year's ASCO annual meeting, the 2019 meeting, we reported that pembrolizumab has activity in patients with breast cancer that have a high tumor mutational burden. And we think that's an exciting observation. Some of those patients actually had quite prolonged disease control and that the abstract has been presented.

The poster is available on the TAPUR website, tapur.org, for anyone who wants to look at the details. And there are some manuscripts of preparation. So TAPUR we hope over time we'll continue to report out both positive and negative results. They can't really help to guide the use of these well-sampled therapies. And, of course, it's also a mechanism, whereby the drugs can be provided to patients at no cost to them, because all the drugs in the study are being provided by the participating pharmaceutical companies.

[DR. NATHAN PENNELL]

Yeah, it really is a win-win situation. The patients get access to the drugs without having to worry about whether their insurance will cover the off-label use. And the companies learn whether their drugs may have expanded indications outside of where they're currently used.

Well, Suanna and Rich, thanks so much for joining me on the podcast today.

[DR. SCHILSKY AND MS. BRUINOOGE]

Thank you.

[DR. NATHAN PENNELL]

And until next time, thank you for listening to this Journal of Oncology Practice Podcast. I hope you enjoyed what you heard today. And if you did, don't forget to give us a rating or review on Apple podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JOP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper will be online at ascopubs.org/journal/jop in August 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell and Dr. Kircher discuss the push for increased price transparency among stakeholders in an effort to control the rising costs of healthcare. Read the related article on ascopubs.org.

TRANSCRIPT:

Welcome to the latest Journal of Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Americans are very familiar with comparison shopping for goods and services based on the price. I can buy anything from a car or a television to life insurance to hiring a contractor to remodel my home.

And I could expect that the price of that good or service is going to be easily available. It's going to be accurate. And then I can compare it to their competitors prices. So I can then make my decision based on that price and the quality of the goods or services.

But what if you wanted to shop around for your health care? How easily can we determine the true out-of-pocket costs for, say, a hip replacement or a screening colonoscopy? In truth, I bet aside from a purely cosmetic procedure, most people don't ever recall being told what the price is of a medical procedure before having it done.
So why is medicine different? And how does this impact the cost of health care? And what can we do to improve price transparency? With me today to discuss this issue is Dr. Sheetal Kircher, associate professor and GI medical oncologist at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Dr. Kircher is a member of the ASCO Health Equity Committee and was a recent ASCO Health Policy Fellow from 2018 to 2019.

We'll be discussing her paper, "The opaque results of federal price transparency rules and state-based alternatives", to be published in the August, 2019 JOP. Welcome Dr. Kircher, and thanks for joining me today.

Thanks for having me.

So first of all, can you briefly kind of review why aren't health care costs like other goods and services? And why isn't it easy to understand and compare between them?

There's a lot of reasons that health care costs are really just fundamentally different than really almost any other goods or services that I can think of. Taking your example of shopping for a TV, when you know which TV you want, you to go to multiple stores. You check to see if there's free online shipping. And you choose the lowest price.

Even if you don't know what TV you want, you can see what the cost is going to be. And this cost is going to be inclusive of tax, shipping. And you can even see what that cost will be if you had a coupon or promo code.

In addition to the cost of these TVs, we will see ratings, hundreds, thousands of people with commentaries on their experience with that exact product. So many times, you could even return it. So as we can see, health care is just really different. The stakes are higher.

So even when we use this word, cost, shopping around for health care, and things like that, already that kind of seems like a misnomer. For the individual case and the actual cost of a service, it's complicated. It's difficult to figure out because almost nobody pays what we think of as like the list price.

The literal list price for hospitals is called a charge master. A charge master is really just the list prices out the gate that a hospital comes up with and becomes a starting point for negotiation for payers. And then each plan will have a different contracted rate for that service.

And this is problematic, isn't it? Because the charge master is sort of the-- when people start, at least say with the federal regulations, that's the price that they're sort of trying to get people to put out there. But that's not necessarily all that helpful.

Exactly. And you know, in addition, because there's such variation in what the patient will actually pay at the end of the day after their insurance coverage kicks in, when you look at the hospital list of prices, it's difficult, even for myself with a medical degree, to understand what I'm looking at. For example, if I'm thinking of a single service, like a colonoscopy, there could be many components to a colonoscopy, such as the doctor fee, facility fee, pathologist, anesthesiologist. So even if you saw the word colonoscopy on one of these lists, it's impossible to really know if that's inclusive of all the components of that procedure.

So say a patient was able to actually get a hold of these contracted rates instead of the lowest prices. And then they were able to know all the components of that service. They would still need to understand the specific cost sharing details of their insurance plan, such as like how much the deductible is, what's their copay, what's their coinsurance. In my experience, and I think it's well-published in the literature, that most patients even struggle to just know what the definition of those things are, like your deductible, let alone what their actual amounts are.

You know, it does sound complicated. And obviously, I think a lot of doctors are familiar with the multiple different charges and whatnot. But at the same time, given the complexity of modern technology and whatnot it doesn't sound to me undoable for a particular hospital to bundle all of the costs of a single procedure together and to somehow link to what your insurance company should cover for that kind of thing. It does not seem to me like this is an undoable technological fix if someone wanted to do it.

I agree. There's been a lot of attempts, both at the state level and federal, to really address this issue. I mean, even taking a step back even further, institutions have tried to, at least for their patients, provide more accurate down at the patient level estimates of their costs. And as simple as it sounds, it is actually quite difficult. And the reasons are because a lot of people contracting from payers as well as insurance it still is very opaque, even in people that are highly skilled and trying to figure this out.
So if you are an actual patient, I mean, I think that the challenges just become even greater. But some states have taken some more kind of in the weeds active approach to improve price transparency in health care as a whole, including oncology. [INAUDIBLE] states have implemented or at least passed laws where they create something called an all-payer claims data set or APCDs.
What these are it's still a list of prices. I think it tackles some of these issues that we just talked about, because what these lists are, they account for the negotiated price, as opposed to the pre-negotiation charge master. So basically, it's the price after the coupon. You know, it's like the real price.

Most of these data sets, or at least many of them, have incorporated quality metrics. Now, I would have to say that the quality metrics between states is all over the map. Nobody has agreed on these quality metrics. But it's at least one more tool to help the patient in addition to cost to make decisions.
I think a kind of interesting point this all brought up as we were doing this work is almost like a bigger question of do patients want to comparison shop for their health care. So I mean, if my primary care doctor, who I trust and I know, and I've known for 15 years, recommends a procedure, so say a colonoscopy, I'm likely to choose the doctor and the facility that she recommends.

I don't even remember if you go to get a procedure, they usually don't even tell you ahead of time what the cost is and ask you if that's something you're interested in paying. Usually you just schedule it, and you do it. And you get a bill after the fact.
That would have to be a pretty big shift in the culture of how we approach paying for health care if we were going to start comparison shopping. You'd have to understand that you needed to do that to begin with. You'd have to know how to do it and how to compare these things. It's certainly not undoable. It's something, again, that we do for almost every single other thing that we buy, but it would require quite a major change.

Absolutely. And there's an even larger price transparency kind of movement going on. In relation to we were just saying about a patient-- say an oncology patient is starting chemotherapy. Federally, there's multiple different efforts that are trying to improve price transparency. So the oncology care model, one of the 13 kind of pillars of that care plan, one of them is delivering out-of-pocket costs before treatment starts.

Now, in oncology specifically, this is problematic and very challenging. You know, kind of trust me, we've tried. And we continue to try because when you think of the drugs we give oral chemotherapy, targeted agents, and then IV chemotherapy, we're not only dealing with totally different modes of treatment. We're talking about different payment structures of how cost sharing works.

So typically, IV chemotherapy is on our hospital outpatient benefits, while oral chemotherapy is covered by our prescription drugs. Now, both of those, in say Medicare for example, are completely different cost sharing structures. So the experience for a patient picking up their oral chemotherapy is at essentially a retail pharmacy or if it's perhaps a specialty pharmacy. But there's a cash register. And you're paying for it there.

The experience of paying for your IV chemotherapy is just like you described with the procedure, where you get it done. You get the bill at home. And just the experience alone is really different.
So federally, for this specific charge master display, so as of January 1st, all hospitals must publicly display their charge master. You know, like I said, these were never intended for consumer viewing. So they were first mandated to exist in the actually the Affordable Care Act. And the Trump Administration has really built upon this and said, why make patients ask for the charge master. How about we just require the hospitals to publicly display these? So that's where this kind of mandate came through.

It's interesting because as we went through this exercise in the publication, and the codes they use, the abbreviations, even with a medical degree, I had a hard time deciphering what they said.
Yeah, it does seem as though a lot of hospitals did not take this as a mandate to try to make this a transparent and useful thing. They said, well, the requirement is we're going to put it up. And here's our Excel spreadsheet or our PDF with all of the jargonese there. And you can do with it what you will.

Absolutely. And I wasn't surprised when we saw that even within four months of this being mandated, 88% of the hospitals we looked at in Chicago had it published. They were right on it. They had published it. And it was on their website. Because the ACA had already required that they have it. So really, they just took it out of the file folder and put it on the website without much thought that they were trying to make it helpful for patients.

A lot of disclaimer that a lot of, I think, hospitals overall did a really good job of putting kind of the fine print on there and saying that please speak to your doctor and facility to actually get the real cost. So I think the hospitals overall did a pretty good job of that.
As you and your authors point out, if someone actually did try to use that information to comparison shop, or what I would think perhaps would be more common, they would look it up just to see what the price is going to be forwardly placed they've been told they're supposed to go. They might see a $3,000 charge for their CT, which might have been completely covered by their insurance with no out-of-pocket expense to them at all and decide not to get it because they're afraid they're going to be charged $3,000.
Right. So in the hopes of having this transparent playing field, my major concern is even I, if I saw that amount of money, maybe that would make me pause a little bit actually. And I think the last thing we need to do, especially in these screening tests that there is no shortage of data saying that they improve survival. I want my patients to get them. There's enough barriers, I think, to getting someone a colonoscopy, that I would hate for that to be an unintended consequence of showing people the cost, especially in this inaccurate kind of forum.

So what can we do about this? What do you and your co-authors recommend to try to address cost transparency moving forward?
I think it's exciting that there is momentum here. I mean, I think price transparency, although has become a buzz word, it is going to continue to be an active issue at the state and federal levels. What makes this exciting to me is that it is bipartisan. So we all care about health care, to a different degree, and we all have different strategies.

But I do feel that this is a bigger discussion about transparency, not only here at the patient level, provider level, hospital level even. I really think I hope we're moving to a place where there is a bigger discussion of transparency at all levels. I'm talking even starting up at the manufacturer level.

But from a very practical patient level standpoint, we all encourage people to develop APCDs. There's interesting results that have been shown in some states that there is a good way to show people cost. And by doing so, programs, such as California's program, has actually shown that utilization of lower priced facilities has increased. And most importantly is that when patients are shown a cost and have some sort of way to impact or influence the amount of cost sharing that they will have based on their decision making, there is an opportunity perhaps for patients to choose lower cost facilities.

Now, even as I'm saying this out loud, my first concern and worry is making sure that outcomes are the same. And so I, first and foremost, care about complication rates for surgery and things of that nature. But there are state level programs that have shown that we can have both. It can be a dominant solution.
So I encourage states to especially have the flexibility to accommodate variations in state level health care markets, the states is really where these databases belong. And they should take it the next step further to make them interpretable, inclusive of all cost. And I encourage states and federally to work together to say if we're getting a colonoscopy, that includes services A, B, C, and D. So when patients are comparing, they're actually comparing apples to apples.

Evidence-based standardized quality metrics incorporated into these cost models will help us at least keep thinking about getting to this ultimate goal of value. And it's like hard not to plug when we're talking about cost and everything is this concept of value. And making sure that no matter what structure we choose to show people cost to have it impact their out-of-pocket cost sharing, those services as we have deemed in the evidence to be high value, the screening lung CT, the colonoscopy, really should be at a minimal cost sharing for patients, no matter what sort of structure that we have.

No, that makes perfect sense. One of the things that jumped out here, if you actually have data that using an APCD increase the number of patients moving to lower priced facilities from here, you mentioned from 68% up to 90%, the first thing that would occur to me is that that might actually end up driving down prices from competition, which is something that has never been a successful strategy in medical care for some reason.

Absolutely. The specific program I'm talking about from California is called CalPERS. And it's the government 1.3 million state employee programs. And really, the premise of that program is so interesting because it's the assumption that we can never really decrease the cost of care unless individual consumers are aware of the prices and have some sort of input into their cost sharing and decision making.
Oh, yeah. This is everybody is looking for ways to reduce costs. And when you see success like this, you'd think people would jump all over this. You'd think even hospitals and health systems would want to market that they have lower costs procedures to get more business. It's just very interesting that this is flying so under the radar.

Absolutely. And I do think, though, that there are more and more states actually jumping on board. So I'm hopeful in the next five, 10 years that as the real discussion of the value and value based care continue, this will really, I hope, will become more common.
And Dr. Kircher, thanks so much for joining me on the podcast.
Thank you for allowing me to discuss the paper.

Until next time, thank you for listening to this Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JOP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. And you can also find the full text of Dr. Kircher's paper online at ascopubs.org/journal/jop in August, 2019. This is Dr. Nathan Pennell for the Journal of Oncology Practice signing off.

Dr. Nathan Pennell and Dr. Jennifer Ligibel discuss weight management and physical activity programs for patients with cancer.

TRANSCRIPT:

Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. I'm sure everyone who listens to this podcast is aware that obesity and lack of physical activity are major health problems in the USA, and they contribute to multiple medical conditions such as heart disease, diabetes. But how much do patients and oncologists know about how obesity and lack of physical activity impact cancer incidence or treatment or outcomes? And how do physicians manage these issues in their practice?
With me today to discuss this issue is Dr. Jennifer Ligibel, associate professor at Harvard Medical School and medical oncologist at the Dana-Farber Cancer Institute, where she also serves as director of the Leonard P. Zakim Center for Integrative Therapies and Healthy Living. We'll be discussing her paper, "Oncologists' Attitudes and Practice of Addressing Diet, Physical Activity and Weight Management with Cancer Patients, Findings of an American Society of Clinical Oncology Survey of the Oncology Workforce." Welcome, Dr. Ligibel, and thanks for joining me today.
Thank you so much for having me.
So just to set the stage for our listeners, how big of a problem is obesity and physical inactivity among cancer patients? Is this something that is generally mirroring the larger problem we see in America, or is there anything different about our cancer patients?
Well, we know that obesity and inactivity are risk factors for developing a number of different malignancies. The International Agency for Research in Cancer and the World Cancer Research Fund have both analyzed observational data linking obesity, inactivity, poor dietary quality to the risk of developing malignancy, and have demonstrated really consistent evidence that there is at least 13 different malignancies where obesity, in particular, increases the risk of developing the malignancy. So if you think about the fact that obesity and inactivity are pretty prevalent in the United States, in general, and that these factors also increase the risk of developing malignancy, we find that an even higher proportion of cancer survivors are obese and inactive as compared to the general US population. We also know that treatment that patients get for some malignancies can contribute to weight gain, and also can contribute to inactivity. So you put all of these factors together, and a very large proportion of cancer survivors are at risk for obesity, inactivity, poor dietary quality, or all of those factors together.
I mean, the number that you and your co-authors mention is that almost 1/3 of cancer survivors are obese. That seems like a huge number. So clearly a major problem.
Yes, that's true. And that number has increased significantly over the last decade.
So I know that obesity contributes to cancer risk. But is there data that even treatment of cancer can be impacted by these issues?
Yes. So we know that obesity has an impact on treatment-related outcomes and, likely, on the risk of recurrence and mortality in many different diseases. Breast cancer has been the best studied, where we know that women who are obese when they're diagnosed with breast cancer actually have a 35% higher risk of dying from breast cancer compared to women who are of normal weight when they were diagnosed with breast cancer.
Similar data are emerging in other malignancies. Colorectal cancer, there has been a strong link with obesity and cancer outcomes. Prostate cancer, gynecologic cancers, there's emerging data as well. So we know that these factors can impact the risk of recurrence and mortality. But there's also evidence that suggests that people who have excess adiposity, have metabolic complications of obesity, are at higher risk of complications like poor wound healing after surgery. They're at higher risk of lymphedema and some malignancies. They may be at higher risk of things like peripheral neuropathy related to chemotherapy. So there are a lot of poor outcomes associated with body weight in cancer patients.
Now, I know even dosing of chemotherapy, I believe, obese patients are at risk for under-dosing because people are afraid to give them proper weight-based dosing. So lots of reasons to pay attention to this issue. Is there data, though, that changing that-- intervening with helping patients lose weight or patients at risk losing weight, or increasing their physical activity-- mitigates these risks?
That is a great question, and one that will hopefully be answered within the next few years through a number of large-scale, ongoing phase III trials that are looking at the impact of weight loss, increased physical activity, better dietary quality on cancer recurrence and mortality. We don't have data from randomized trials, at this point, looking at the impact of lifestyle change after diagnosis on outcomes. But we do have a lot of observational data that suggest that individuals who are physically active are at lower risk of recurrence in malignancies like breast cancer, colon, and prostate cancer. And we do also have a lot of information from randomized trials that are smaller in scale that demonstrate that losing weight, exercising more has an impact on shorter-term outcomes, like quality of life, cancer-related and treatment-related side effects like fatigue, neuropathy, joint pain. So we know there are benefits of lifestyle change after cancer diagnosis, but we're still awaiting these large-scale trials that will show us whether changing these behaviors actually reduces the risk of recurrence and mortality.
So already enough evidence that it's important that we address it, but hopefully, we'll have more convincing evidence soon. Can you take us through the ASCO survey? What was the background to doing the survey, and what did it try to assess?
So in 2014, ASCO launched an obesity initiative that really sought to educate the oncology workforce about the connections between obesity and related factors in both cancer risk and outcomes, and to provide tools and resources to help oncologists talk to their patients about physical activity, weight management during and after cancer treatment. There was also a part of the initiative that focused on research and advocacy.
We were interested, given that 2014 was a number of years ago, to look at what were the current attitudes of oncology providers toward these topics? What was their practice? Were they talking about weight? Were they talking about physical activity and diet with their patients?
And what did they perceive as barriers to really implementing behavior change after cancer diagnosis? And so we designed a survey that would be delivered to individuals that were currently seeing oncology patients. And they could be physicians, they could be nurse practitioners, they could be dietitians or anyone that was currently working with oncology patients and was an ASCO member. And then we asked them questions about their practice, about the attention that they paid to these topics, about what they felt got in the way. And then thinking more broadly about how important did oncology providers think that these topics were in the scope of their practice.
Why don't we just jump right into the results? So what were the results from the survey?
So first of all, we found that the people that filled out our survey were pretty typical for the general ASCO membership. So about 2/3 of the people that filled out the survey were based in the US. The other 1/3 were international. We did have a higher proportion of medical oncologists, partly because this was limited to people that were actively seeing patients. We had a nice balance of private practice and academic centers, and we had individuals that were treating all different kinds of cancer. So we were happy with the population that filled the survey out as being fairly representative of oncology providers in the US and more broadly.
We found, when we asked the providers what were their perspectives on issues related to obesity and cancer, that there was a very strong agreement that obesity impacts treatment outcomes in cancer patients. And in fact, more than 90% of the survey respondents strongly agreed or agreed with that statement, which we were very excited to see. There was also high agreement with addressing a patient's weight should be a standard part of cancer care. And most of their respondents felt that it was the responsibility of the treating physician to recommend healthy diet, regular activity, weight management for patients in whom that was relevant.
But there was much less agreement that the oncology workforce felt that they were prepared to be either delivering those interventions or that they had enough information or enough training to really feel comfortable in their skills to help patients start to make these changes. So I thought that was very important that there was high agreement that these things were important, but also a feeling of there needed to be other parts of the health care team that could help patients once these issues were identified in really helping them to make the changes that needed to after diagnosis.
We then asked providers about what they were doing now, and we found that the vast majority of providers that completed the survey indicated that they were asking patients about their physical activity patterns, about their diets. They were assessing patients' weights. And this was both during and after cancer treatment. There was a much lower proportion of survey respondents that were actually making referrals to dietitians, to weight management services for their patients. So although there was a lot of discussion and there was an assessment, there wasn't necessarily the next step, which was helping patients actually incorporate these changes through a referral to a skilled provider.
And then, the last piece was looking at barriers. And I think that this was something that we were actually a little bit surprised about some of the responses. The last part of the survey focused on looking at the respondents' perceptions of barriers. What did oncology providers feel like was getting in the way of patients changing their diets, exercising more, losing weight when it was relevant?
We found that, not surprisingly, lack of time for counseling was something that many providers noted, lack of available resources. So even if you identified that a patient wanted to lose weight or meet with a dietitian, there wasn't necessarily someone that was available. Lack of training or expertise on the part of the oncology provider was also noted. We also found that the majority of participants felt that patients' resistance to behavioral interventions was also a large barrier to helping people make these changes. And this really led us to think start thinking about, well, what is the patient's perception?
And I think that's something that we did not cover in this survey, but that is really critical. Because if we find that oncologists are talking about these topics and are trying to reinforce the importance, but patients aren't hearing that or aren't making these changes, then we're really not accomplishing what we want to. So I think from this survey, we now can see what oncologists feel is important and what they're doing in their practices. And we need to figure out, what are the patients hearing and what is the result of the advice that the providers are giving to patients?
Yeah, that really is an interesting and kind of a surprising piece. So the first part resonates with me. So I certainly address, you know, in my patients that are in follow-up and survivorship, exercise and trying to maintain a healthy weight. And I also feel that I'm not super comfortable with trying to intervene in that myself, but rather try to suggest that they look for SilverSneakers or some sort of local exercise gym or other opportunities or, perhaps, refer them to a dietitian.
But I don't know that I have a perception that the patients wouldn't welcome that advice or that they might be resistant. Is there any plan to try to get an assessment of cancer patients' attitudes on this?
So this is something that we are planning at this time. We are trying to develop a survey and partner with some patient advocacy groups to really better understand what the patients' perceptions of these topics are. There is not much currently in the literature, but there have been some assessments. There was a large study that was done in the UK that looked at patients with colorectal cancer and the attention that was paid on the part of their provider to exercise. And if patients remembered hearing about exercise, they were much more likely to do it.
So I think that something that we really need to better tease out is, what is the patients' receptivity to this type of information? And are the suggestions that oncologists are making enough to get patients, on their own, to seek out a program? Or do we really need to try to educate providers about effective ways of making referrals?
I think the reality is that we also need more programs that patients can be referred to. And something that I think is a real need within the oncology space is programs that help people lose weight that are able to help people become more active, and recognizing some of the limitations that many patients have as a result of their therapy. Things like lymphedema, things like neuropathy, that can be barriers. How can we manage those in oncology patients to help them successfully achieve these behavior changes?
And this is, I think, such a great topic because patients really care about interventions that they can do themselves to help their cancer care and their health. And there's so much out there, in terms of complementary therapies and whatnot. But we have real data on things like diet and exercise, and I think more attention being paid to this within cancer centers would really be welcomed by patients.
I think so too. You know, we, right now here at Dana-Farber, are leading a trial called the Breast Cancer Weight Loss Trial that's a phase III study looking at the impact of a weight loss intervention on recurrence in women who are overweight or obese when they're diagnosed with breast cancer. And when we started this study, we weren't sure what the uptake would be. It's a very different type of model. But we've enrolled now more than 2,000 patients in less than three years. So there's definitely a very, very significant interest in this topic amongst patients.
There's a similar trial going on in ovarian cancer that just enrolled 1,000 patients with a disease that's much less common than breast cancer over just a few years. So I think that the interest on the part of patients in this topic is large and we want to be able to provide them with evidence-based recommendations. There's a lot of stuff out there that's not so evidence-based, especially about diet, and I think that, as oncology providers, we really owe it to our patients to get them the best information that we have about things that they can do to help improve their outcomes and to make themselves feel better during and after their cancer treatment.
And we're very lucky to work at institutions like the Dana-Farber Cancer Institute or here at the Cleveland Clinic, where we've actually got a lot of resources devoted to these efforts. But what can people who work at smaller institutions, or really don't have a lot of infrastructure for this, where can they access data or suggestions on how they can counsel patients or help their patients address problems with obesity and lack of physical activity? Is this something that ASCO can help with?
So as part of the ASCO Obesity Initiative, we developed toolkits for oncology providers and for patients about the role of weight management and physical activity in cancer. And so those are available at cancer.net. They can be downloaded. You can give them to your patients to start a conversation about the importance of these topics in oncology care.
The American Cancer Society also has diet and exercise guidelines for cancer survivors that oncologists can use as a guideline. The American College of Sports Medicine also has a website where they have oncology-trained exercise professionals in different communities. So if a patient wants to work with a trainer that has an understanding of the complications of cancer treatment and the side effects that patients have, that's another good resource.
The other thing that is available in many communities is the Livestrong at the YMCA program, which is a free exercise program that's offered for cancer survivors. This is offered now in more than 700 YMCAs across the country. It's a 12-week program that includes both aerobic exercise and strength training. And this is a resource that I send a lot of patients to, and that is available to people not everywhere, but increasingly more places. So that's another good resource for oncologists and for patients across the US.
Well, that's fantastic. So good, I'm glad we got to plug that on the podcast. And Dr. Ligibel, thanks so much for talking to me today.
Thank you.
And I also want to thank all of our listeners out there who joined us for this podcast. The full text of the paper will be available online at ASCOpubs.org/journal/JOP in June 2019. This is Dr. Nate Pennell, for the Journal of Oncology Practice, signing off.

Dr. Pennell talks with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer."

Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Potentially avoidable hospital readmissions are a major target for reducing costs in the health care system. However, for cancer patients, the issue goes way beyond cost.

Many of our advanced cancer patients have a limited lifespan. And every unnecessary day they spend in the hospital is one less day they spend at home with their loved ones. The reasons behind cancer patient readmissions may differ from other types of patients. And so broad efforts to reduce hospital readmissions may not apply quite as well to this population unless we understand the specific reasons behind readmissions for our vulnerable population.

Today we're going to be talking about this topic with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer," which was published in the May 2019 JOP. Welcome, Conner, and thank you for joining me today.

Nate, it's truly an honor to be on the podcast. I appreciate your time and [INAUDIBLE].

So first of all, can you give us a little bit of background on why hospital readmissions are a topic that people are talking about? How big of a problem is this and what's the scope of the issue?

To start with, just hospital admissions period are a major topic within cancer care and all of medicine. If you go back to the health care cost and utilization project report since 2009, more than 4.5 million cancer related hospitalizations amongst adults. So that's hospitalizations.

Some percentage of these are potentially avoidable both in the general medicine literature and in the oncology literature. and both from a cost and value standpoint and from quality of cancer patients' lives, I think these are important issues to think about in terms of addressing.

And then when we looked, particularly in our study, we focused on readmissions by which we define having a panel of patients who already had admission once and then looking at subsequent admissions after that.

There is a fair amount of literature out there looking at causes of hospital readmissions as a target for improving value based care. What do you think is different about cancer patients that makes this something we need to study uniquely in them?

I think, in general, amongst a variety of different subspecialties, there's an importance in focusing on targeting each individual population to understand the nuances of that population, whether that's a literature on COPD or heart failure. And oncology in particular is still a wealth of drugs with a wealth of potential consequences and with a sub-population within oncology of advanced cancer patients who have defined limited lifespans.

There's a whole host of factors and different unique circumstances that could potentially affect their readmission profile a little bit different than other general medicine populations. And I think the greater understanding we have of each subset of patients within a number of disciplines is probably going to target our interventions to be more likely to be successful.

And I think that makes perfect sense. One of the other things you mentioned in the background section of your paper is that many of the studies looking at potentially avoidable readmissions have not incorporated patient reported outcomes. And why do you think that would be an important thing to include in the study?

I think looking across oncology care, the study by Dr. Schrag and Dr. [? Basch ?] and colleagues comes to mind. There's been an increasing interest in incorporating patient reported outcomes in order to better pair these with our other outcomes.

And I think that our hope with this was to gain a greater understanding of what kinds of symptoms and other things patients report and trying to identify if there is any correlation with admissions. And the same thing's being done across a number of different facets of oncology care.

Yeah. I'm not sure people outside of oncology understand that there's a significant percentage of our inpatients are admitted for symptom control specifically as opposed to general medicine problems like pneumonia or blood clots.

And so definitely in that case being able to assess their symptom burden makes perfect sense when you're trying to do the kind of study that you're doing. So speaking of your study, can you walk us through the design? How did you put this together?

So this was a longitudinal cohort study of consecutive patients that were admitted to the hospital. And patients were enrolled. And as part of their enrollment, their symptoms were assessed at the time of their enrollment.

So this was a one time symptom assessment within two to five days of their hospitalization when they completed a symptom burden questionnaire essentially. We took available data that we had.

And we had two coders go back, review the medical record with a focus on the discharge summary to try and understand the reason for hospital admission. And then we had a peer review system to try and identify which readmissions were potentially avoidable.

And we used some adaptive criteria, which has been utilized in some other studies in leukemia an GI cancer. And that process was essentially two physicians doing an initial coding review using these criteria. And then anything that was considered potentially avoidable by either of those physicians went to a panel that included two board certified oncologists.

Yeah. I'm curious about this. I know that there are published methods for how they do this. But can you give us an example? How do you determine if a patient had an a potentially avoidable readmission? What's an example of something they might find.

There's no question that it's a challenge. And it's rife with some subjectivity at times. In order to try and minimize that, we have defined criteria. For an example, one of those is premature hospital discharge, which in this study was defined as being readmitted within seven days of discharge with identical symptoms to the prior admission. And that's by a review of the hospital discharge summary.

OK. That makes perfect sense. And you would think that that would be a significant risk for patients since the length of stay is such a big target for hospitals to try to reduce costs. And also our patients typically want to go home.

You know, we have to sometimes convince them to stay when we think they need to stay. OK. So if they were readmitted within seven days with the same symptoms that's how you determine that. So tell us some of what you found.

Thanks, again. Major points from our paper are, first, similar to some other studies that try and look at potentially avoidable hospitalizations at large. More than 30% of the admissions were qualified as potentially avoidable readmissions, which I don't think is anything that has ever been described.

Again, that's fairly consistent with actually the general medicine and with some other oncology literature, but it speaks to the importance of the topic and the sizable possibility of interventions down the road. And the two major important risks that we identified in a multivariable model were marital status, and which we think is a proxy for social support and was protective against potentially avoidable readmissions, and higher physical symptom burden.

And those with higher physical symptom burden were more likely to have potentially avoidable readmissions. And finally, when we looked at the most common reasons as using our criteria for potentially avoidable readmissions, those were premature discharge from a prior hospitalization and also not having what's called a timely follow up, which was a seven day follow up. And so that speaks in our mind to the hazardous time period that is the discharge is fraught with a lot of possibilities of difficulty in terms of making that transition.

Yeah. I think that makes perfect sense. I know our institution in particular has instituted a mandatory call from the outpatient team to a patient the day after they're discharged to just check and see how they're doing. And then we try to get everybody an appointment within seven days although that's not always possible. Are there any other interventions that you think would come out of what you found that might help reduce potentially avoidable readmissions?

I think from the social support side of things, given that social support can be challenging, there is an idea that if we identify patients with that limited social support that that might be the patients that we target for patient navigation programs, more intensive social work involvement programs, or a specially designed care transition programs at hospital discharge as well as potentially patients who have a higher physical symptoms.

And the association with higher physical symptoms also makes perfect sense, although that's always a challenge to address appropriately. I know that there's a lot of focus certainly in solid tumors about integrating palliative medicine and [INAUDIBLE] of medicine support for patients with solid tumors to control that. Is that something that you think could be helpful in this setting as well to help reduce readmissions?

Absolutely, Nate. I think that the hope would be that this also raises a possibility of identifying a patient population that may already be plugged in with palliative care. But if they're not, this could help identify another group of patients that can benefit from integrated palliative care with the hope being that we can identify interventions that can reduce their hospitalization burden.

And where do you think we're going to go here in terms of research. So you've identified some nice potential associations. And there's some low hanging fruit in terms of arranging fast follow up. But what's the next steps in terms of trying to reduce potentially avoidable readmissions for our patients?

I think an integrative palliative care interventions for those with high physical symptom burden. And I think that targeted interventions such as more intensive social work involvement or care transition programs for those with limited social support would be potentially good intervention based studies to start with.

I also think that, as you mentioned, you raised good points about there's still a good bit of research to having a greater understanding within the world of oncology. What is the ideal follow up after discharge for each sub-population even within oncology? And there's probably a great deal more research into understanding that as well as more about the physical symptom burden of hospitalized patients in oncology.

I don't know what your opinion is. Do you think we'll ever be able to avoid almost or all potentially avoidable readmissions?

No. I don't think so. I think that it's a patient population that has a high symptom burden and has a high complexity of care. But I do think that any interventions to reduce the burden of hospitalizations could potentially have far reaching consequences.

I know. I agree with you. I mean there's no way we'll ever be able to avoid this completely. And we all have experience with patients who we can tell when we're getting ready to discharge them that they're at high risk of not successfully transitioning home and yet they want to try.

Perhaps they might be better off in a facility where they could have a higher level of care. But they really want to try to get home. And we want to give them the chance to succeed. And it's just not always successful. So giving them every resource that we can sounds like the right thing to do.

[INAUDIBLE] I agree with you totally. I think the other point to mention is just that the care transition time is a very fragile one. And other interventions to try and improve that transition period as well are something that would be of interest for us or other folks to explore around this topic.

Yeah. It sounds like that would be ripe for a quality of care study to look and see if really intensive interventions in that first few days or a week after discharge can reduce this. I know that we've moved forward with doing that, but I'm not sure if we have any data that it's effective. But it certainly makes sense that it would be helpful. Connor, thank you so much for talking with me today.

Thank you so much for having me.

And I also want to thank all the listeners out there who joined us for this podcast. The full text of Dr. Johnson's paper is available online at ASCOpubs.org/journal/JOP in the May 2019 issue of the JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell talks with Dr. Ray Page about efforts to address the opioid crisis impact onthe care of patients, and what role oncologists can play on this issue.

Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP.
The opioid crisis continues to be a major public health issue, with increasing attention at both the state and national level. Efforts to address this issue are highly relevant to oncologists, because we treat a unique population of cancer patients for which opioid prescriptions are an established standard of care.
So how will these efforts to address the opioid crisis impact the care of our patients? And what role can oncologists play on this issue?
Today, we're going to be talking about this topic with Dr. Ray Page medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Texas, who currently serves as chair of ASCO's Clinical Practice Committee, is on the ASCO Government Relations Committee, and is the current ASCO delegate to the AMA House of Delegates, about his new editorial titled, "Opioids and Cancer Pain, Patients' Needs and Access Challenges," which will be published in the April 2019 JOP.
Ray, thanks for joining me today.
Thank you.
So can you start out by giving our listeners a little background on the magnitude of the opioid problem in the US.
Sure, Nate. Let me just first say, the opioid epidemic is real and is startling. The CBC reported that in 2017 that over 72,000 in the United States died from drug overdoses. And this included over 47,000 people who involved in drug overdoses of opioids.
And most of us have heard from the media that the biggest increase in use is through that synthetic opioid fentanyl. And it's often laced with heroin. And the recent volumes that have confiscated at the US border are enough to kill ever single US citizen.
And the escalation of opioid abuse is really complex societal issue. And it includes contribution from all of those social determinants of health and mental illness. And when policymakers sometimes they like to look at a one size fits all kind of solution, which means they oftentimes want to largely focus on physician prescribing habits and just regulating patient access to opioids.
Is there evidence that this kind of solution of targeting opioid prescriptions is impacting opioid prescribing in cancer patients?
There is a negative impact there. But let me just say that cancer pain is very real and it's very frightening. And we know that cancer pain is historically undertreated. 8 out of 10 advanced cancer patients experience moderate to severe pain. And about 55% of cancer patients and 40% of cancer survivors experience chronic cancer related pain. So upwards of 43% of cancer patients and 10% of survivors use opioids to manage chronic cancer pain.
Because of the heightened media awareness about the opioid epidemic, cancer patients are really experiences a lot of fear firsthand. Many of my patients have expressed to me that they actually have a fear of dying from taking opioids. And there's also of addition. And then on the other hand, they also have a fear that they may not even be able to get their hands on pain medicines at all.
That actually is a really interesting topic that I hadn't thought of because I have the same problem with my patients worrying about taking opioids. You think that this being so much in the public eye is really influencing cancer patients' ideas about whether they should be taking opioids or not. They feel like they're at risk for addiction and contributing to the problem.
Our cancer patients I think do have those real concerns and they have fear over it. And we're actually seeing that about a 1/3 of cancer patients and survivors are actually having difficulty to getting access to their prescribed opioid medications. And that has continued to increase markedly since just a few years ago in 2016. And the vast US oncology practices are concerned that restrictions on opioid prescribing is going to ultimately result in undertreatment of cancer pain.
So it's these kind of dynamics what makes it difficult for physicians to treat pain, particularly cancer and cancer survivors. And while judicious prescribing is important, patients with cancer and cancer related pain, they need to have consistent access to pain control.
Well, I think we can all agree on that. Before we talk about how we can protect cancer patients' access to these drugs, can you talk a little bit about what is being done sort of at the state and national level to address the opioid crisis and sort of how that's impacting our cancer patients?
Yeah, absolutely. The opioid epidemic will continue to be a bipartisan priority for both state and federal governments with currently over 100 state bills that are out there that are identified. In a lot of upcoming state legislative sessions, there will be consideration of bills that are related to such things prescription fill limits and prescription drug monitoring programs and opioid prescribing guidelines.
And we're all expecting to see bills that are going to be related to the identification of outlier prescribers and bills that are promoting the utilization of opioid alternative therapies in the cases of both acute and chronic pain.
Just on the federal level, you know in 2016, President Obama, he signed the first major federal addiction law in 40 years. And that was the Comprehensive Addiction Recovery Act. And that bipartisan legislation authorized evidence-based prevention and treatment programs and recovery programs and law enforcement initiatives to help prevent overdose death and proper prescriptions.
And as you had asked, in 2017 when President Trump came into office, he announced that his administration was declaring an opioid crisis and made a national public health emergency under federal law. And as a result, the White House office of the national drug control policy directed numerous federal agencies to address the opioid problem. But that was largely within their current budgetary confinements. But I think actions by both administrations had positive impacts on the opioid problem primarily just by initiating activity in our government agencies.
So when the various laws and policies are passed, do they have built in protections for vulnerable populations that need access to opioids, like cancer patients?
Yeah, that's one thing that we've pushed a lot for. And in general, most of them do. And so President Trump signed a sweeping legislation in 2018 that was touted as the single largest bill to combat the drug crisis in our countries history. And there was a lot of efforts to do things like expanding access to treatment for substance abuse disorders and those kind of things.
But, for example, January 1st of this year, as part of that law, it included new opioid prescribing policies that will impact Part D beneficiaries and the prescribers. And this includes such things as real-time safety alerts on pharmacy dispensing of opioids and drug management and utilization tools and the improvement of communications between the pharmacists and the physicians.
But as you asked, one important note about this legislation that was passed is that residents of long-term care facilities and those that are in hospice care and patients receiving palliative care or end of life care, and patients being treated for active cancer related pain, they are exempt from a lot of these interventions.
Well, it's good that at least someone is considering our patients in this. But I know that certainly-- I believe ASCO has quite a bit of concern about maintaining access to patients. So what role is ASCO playing in this issue?
You know, Nate, ASCO is very sensitive to the needs, to address the opioid crisis and to support thoughtful and evidence-based interventions aimed at decreasing substance misuse and abuse and overdose death. However, ASCO really continues to advocate for appropriate access to pain medications for cancer patients, recognizing that that typical one size fits all solution risks oftentimes marginalizing our cancer patients and their needs.
And so in 2016, ASCO released an ASCO policy statement on opioid therapy which emphasizes the unique pain management needs of patients with cancer and especially those with advanced disease. And in this policy statement, ASCO points out a lot of core principles to balance public health concerns and cancer patients' needs.
Well, I really like the fact that ASCO is focusing not so much on specific individual needs, but rather making sure everyone recognizes that there is no one size fits all solution here and also you know acknowledging that there is a real problem with opioid misuse in the United States, but that our patients need to be considered carefully in this.
One of the things I liked about your editorial was focusing on how physicians might actually be able to learn about managing pain in cancer patients and not necessarily just focusing on the use of opioids. Can you talk a little bit about that?
Yes, sure. You know, just in general, as we all know, as oncologists, we rely heavily on the use of opioids. But we should never rely solely on the use of opioids. And we need to determine if opioids are indeed the right drug for particular type of cancer-related pain.
And so ASCO published recent clinical practice guidelines for chronic pain management in cancer survivors that gives advice on careful assessment of pain and its effects on function and of the possible risk associated with an opioid. And so I generally recommend that clinicians review some of these practice guidelines because many of these recommendations can help reduce opioid prescribing and actually consider other good, viable non-opioid alternatives, such as using pain specialists and other interventional procedures.
Yeah, I think everyone would benefit from being aware of the problem and making sure that they are using opioids appropriately. I guess I'm just a little concerned about how all this attention is impacting our patients and their access to drugs. We did a JOP podcast, oh, I think a year or so ago with Dr. Bruera, who is a palliative care specialist at MD Anderson, who published a study showing that palliative care physicians were actually prescribing significantly less morphine equivalents for cancer patients. And there was a lot of alternative treatments, such as tramadol, that were being used. And we had a nice discussion about how perhaps some of that was a good idea. But they're also putting sometimes patients at risk of being under treated.
Yeah, that dynamic is very complex, because I think we all realize that are certain types of pain that do get effectiveness with opioids to get appropriate pain relief. But the palliative doctors are usually very good and many oncologists also about entertaining those alternatives. And so oftentimes there are many kinds of cancer pain syndromes, both acute and chronic that can be managed with non-opioid alternatives.
We as oncologists, we realize that this is a really vulnerable patient population. And we'll continue to develop and utilize all the latest advances in the comprehensive management of cancer in accordance with published evidence-based physician developed guidelines. However, we also want to design the statutory and regulatory requirements do not unduly restrict access to opioids and acknowledge the need to exempt cancer-related pain in our opioid policies.
And I think that's absolutely critically important. And you know this is exactly the kind of function that societies like ASCO and the AMA really exist for, to protect our patients and the physicians who are prescribing these necessary medications to our patients.
Well, it's been my pleasure to share this publication with you. And I hope it will be an important educational tool for the oncologists to work on to deal the opioid access problem for our patients.
Thank you so much for joining me. I also want to thank all of our listeners out there who joined us for this podcast. The full text of the paper will be available online at ascopubs.org/Journal/JOP in April 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell talks with Dr. Genevieve Digby about the importance of timely care for cancer patients, and more specifically, lung cancer patients.

Hello, and welcome to the ASCO Journal of Oncology Practice Podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. On this month's podcast, we're going to be talking about a new study from the JOP Quality and Action series, titled Improving Timeliness of Oncology Assessment and Cancer Treatment Through Implementation of a Multidisciplinary Lung Cancer Clinic, published online in the JOP, January, 2019.
Joining me today on this podcast is the author, Dr. Genevieve Digby, assistant professor in the division of respirology at Queen's University School of Medicine, where she's also the clinical lead for the lung diagnostic assessment program. She has an active interest in quality improvement projects, which is what led to this paper that we're going to be discussing today. Dr. Digby, thank you for joining me.
Thank you so much for the invitation.
Obviously, everyone likes to be seen as quickly as possible when they're trying to get into the doctor, but can you give us just a little bit of background into what led you to do this particular quality project? Why is the timeliness of care more important for cancer patients or, specifically, lung cancer patients?
So great questions, Nate. Timely care is very important for patients, as you pointed out. In fact, the Institute of Medicine has timeliness as one of the six dimensions of quality. And for lung cancer patients this is particularly important, as we know that there's evidence to show that patients who have delays in their diagnosis or delays in treatment, that this is associated with progression of disease, and there's evidence to show that more advanced disease is associated with worse outcomes. And as we know from the lung cancer screening trials, earlier detection of disease is associated with better outcomes.
Not only is timeliness of care important for patients from the point of view of getting their treatment underway, but it also is important in terms of the anxiety and distress that patients have. So we know that the longer delays are associated with more distress, and lung cancer patients to begin with are some of the patients who have the highest levels of anxiety and distress amongst oncology patients. So for us, the study arose because of an identification locally that there were delays in our care processes in regards to transitioning patients from the diagnostic phase of the lung cancer pathway to the treatment phase and a desire to improve those care processes.
I think that that really resonates with me. I know at my institution we've been paying attention to the time to initiate treatment for a while, and it's not like going to see the dermatologist. When you're diagnosed with cancer, you really have a lot of anxiety, and you want to get in to get treatment as quickly as possible. And of course, as you've mentioned, especially for early stage lung cancer, there's pretty good data suggesting that the longer someone waits to make a diagnosis, the more likely they are to have their potentially earlier stage cancer turn into a later stage cancer with worse outcomes. So I applaud you for addressing this.
And in your particular project, you focused on the establishment of a multidisciplinary clinic. And this is something where I think a lot of the literature out there on looking at processes and time to treatment has focused on that. So is there data suggesting that multidisciplinary clinics specifically are a good intervention for improving timeliness of care?
So that's a good question. And the literature varies in terms of its robustness based on the type of cancer that we look at. So my group published a systematic review looking at multidisciplinary clinic models in lung cancer specifically. And we were surprised, actually, by the relative paucity of data in terms of what the optimal catalytic characteristics are, even just in terms of the number of studies that's actually evaluated a multidisciplinary clinic, per se.
In other cancer types, there is evidence that multidisciplinary clinics lead to better collaboration between specialists. There is some evidence, even in lung cancer, that perhaps there's better compliance with staging guidelines and guideline-based care when care is delivered in a multidisciplinary clinic. And there's also some evidence, though limited again, especially for lung cancer, surrounding the patient experience and patient satisfaction with their care when it's delivered in a multidisciplinary clinic model.
Yeah. Honestly, I don't think I've ever heard anyone argue that there's a downside to a multidisciplinary clinic. But I do appreciate studying measurable metrics that may demonstrate benefits because, of course, you have to get support for these sorts of things. So why don't you take me through your project's design, and what were the goals that you tried to achieve?
So this is a quality improvement study. We started by identifying what our overall goals and outcome measures were and how we would go about achieving those goals. For us, the focus was to improve our transitions from the point of care of receiving a diagnosis of lung cancer through to starting treatment with an oncologist. So this particular setup was due to the fact that in our center we have a separate thoracic surgery program where patients with suspected early stage disease directly go to a thoracic surgery program and those with more advanced disease or suspected non-operable disease are initially managed by a respirologist, and then are seen through with the appropriate thoracic oncology specialist subsequently.
So for us, we looked at our data, and we actually identified that that time from transition, where a patient receives a diagnosis of lung cancer, to when they're first assessed by an oncologist was upwards of about two weeks. The time then to go on and start their first treatment for cancer was in the range of 40 to 45 days. And we identified that there was room to improve and set a target of reducing both of these individual time frames by about 10 days.
We hypothesized that if it could improve timeliness to seeing an oncologist from about 14 days to closer to 4 days-- 3 to 4 days-- that we would similarly lead to maybe about a 10-day improvement in time to treatment on the other end. So our improvement plan was to launch this multidisciplinary clinic. And we used a quality improvement called plan, do, study, act cycles, or PDSA cycles, to help facilitate that and fine-tune our multidisciplinary clinic along the way to make it even more efficient.
That sounds great. It sounds like a very worthy project. So what did you find?
We found that by implementing a multidisciplinary clinic, even within a very short time of implementing it, that we were able to significantly reduce the time from a patient's lung cancer diagnosis to when they were first assessed by an oncologist. In fact, just with the implementation of the clinic, we led to about a 10-day improvement. We fine-tuned our processes to help create sustainability of the teams. Initially, there was still some variability. And we were able to maintain about a 10-day improvement overall over time.
What we found though, and what was really interesting, was that as we went about our change processes, we had ongoing improvement in time to treatment, so that time from lung cancer diagnosis to time to first treatment. With our initial clinic implementation, we had about a 10-day improvement in time to treatment as well. But as we noticed, as we fine-tuned our processes, that improvement actually increased such that we overall reduced time to treatment from about 40 days at baseline to 15 to 20 days by the end of our quality improvement initiative.
And that is incredible. I think, to me, was the most impressive thing is not so much that you, by moving up your evaluation by 10 days, you improved time to treat by 10 days, which makes perfect sense, but that somehow implementing this entire project, you greatly exceeded your expected improvement in time to treat. And so, did you look at what specific interventions might have led to that even better improvement than you expected?
So that's a great question. And as you said, what surprised us was the extent to which timeliness, in terms of receiving first treatment improved, even beyond just time to seeing an oncologist. And when we considered the data, some of the things that came out were likely the increase in collaboration that we were seeing amongst specialists, particularly medical and radiation oncologists in terms of being able to decide on a treatment plan a bit sooner and get that plan up and running.
In fact, when we looked at the data, the patients that had the greatest improvement in time to treatment were those with stage 2 and 3 lung cancer, and also including patients with stage 4 lung cancer. And those are often-- especially stage 2 and 3-- where patients are most likely to need a concurrent chemoradiation, where the treatment plans are often decided together amongst the radiation oncologist and the medical oncologist. And so having that ability to discuss the treatment plans and come up with a clear plan sooner is what we hypothesized is leading to be faster kind of treatment.
To evaluate this further, we actually also have recently completed a qualitative study, where we interviewed physicians, and including patients and caregivers, about the impact of a multidisciplinary clinic. And while I don't want to give away all the results yet before it's published, one of the themes that comes up certainly for the physicians and particularly oncologists is just the overall ability to collaborate and have real-time discussions with each other and with the patients about what their treatment plans would be, leading to a faster implementation of that plan.
Well there you go, listeners. You're getting a sneak peek of a future study going to be coming out of this group. But I think that makes perfect sense. So again, as a group that has, at least internally, been focusing on improving our time to getting patients to treatment, I think just having an emphasis on studying how long it takes to treat and that everyone understanding that it's a priority to try to make that as short as possible seems to just lead to improvements because everyone's aware that it's an important aspect of treatment. And things tend to show improvements without any real specific interventions taking place.
And then, of course, the multidisciplinary clinic. It makes perfect sense that multidisciplinary care would be better coordinated. So I think that that's a really nice validation of what you were trying to do. So how would other centers that maybe are starting to look at this, how would they take what you've done and apply it to their own programs?
So that's a great question. I think there's a few things to consider. Firstly, quality improvement processes can be instituted in any organization. And part of quality improvement is identifying what the main barriers are to achieving the timeliness of care goals that an individual center has and just implementing the PDSA cycles at their own institution to help achieve those targets because the barriers can be different between different organizations. So where possible, I think eliminating the silos that exist in our care models of the traditional model of seeing one person at a time and really trying to get people to work together, that can be challenging administratively. But once those barriers are overcome, it's actually more convenient for people to really work collaboratively to improve patient care as a whole.
That's great. And this really fits in nicely with both the US National Cancer Institute and ASCO, in particular, have really paid a lot of attention in recent years to teamwork and building team science to help improve outcomes. And I think that your study is a wonderful example of how that can lead to direct and measurable improvements in care.
Well, thank you. We certainly think that we've led to some improvement locally and hope that other centers can learn from what we've learned to help drive change.
Dr. Digby, thank you so much for talking with me today about your study. And I really want to thank you for sharing the results of your project because I think high quality quality improvement projects that are going on all over the world, really, but oftentimes don't get shared outside of the individual team or institution where they're doing them. And this is going to allow, hopefully, a lot of people to see how investments in teamwork and trying to improve on these metrics can lead to really important results for our patients.
I completely agree. It's important to share the knowledge that's learned, particularly with quality improvement. We're all working towards common goals for delivering better patient care, and it's great to be able to share those learned experiences with others.
And I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on January 7, 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Chino discusses the past, present, and future of prior authorization in cancer care with Dr. Michael Anne Kyle, a health policy expert with a research focus on utilization management and patient burdens from prior auth.

TRANSCRIPT 

Dr. Fumiko Chino: Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity.

On today's episode we'll be discussing prior authorization in cancer care. Prior auth has been a recent focus of healthcare policy and reform, given rising demands seen by both providers and patients. I'm excited to welcome an expert on prior authorization to the podcast today. Dr. Michael Anne Kyle is an Assistant Professor in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at UPenn. Her work focuses on defining and measuring patient administrative burden in cancer care delivery with a focus on prior authorization and how it impacts cancer care delivery, including patient wellbeing and outcomes. She holds a Ph.D. from the Harvard Business School, an MPH from the Harvard T.H. Chan School of Public Health, and a Master's in Nursing from the UPenn.

Our full disclosures are available in the transcript of this episode, and we've all already agreed to go by our first names for the podcast today.

Michael Anne, it's so great to speak with you today.

Dr. Michael Anne Kyle: It is so great to speak with you too, Fumiko. I'm really excited about this conversation and our shared interest in improving prior authorization.

Dr. Fumiko Chino: I love it that you've taken time out of your day to talk to me.

To start us off, can you tell us a little bit about yourself and your career? How did you transition from being a nurse into a health policy researcher? Did you always plan on a career in research or was there some specific event or transition that put you on this path?

Dr. Michael Anne Kyle: There was not. And so for anyone who's listening, who isn't sure what they want to do, I guess I have a good story to show that you actually don't need to know in advance. I started out as a critical care nurse and I still actually work as a critical care nurse. But as I think anyone who is a clinician who's listening to this knows, when you work in the healthcare system you just see so many things that could be different, that could be better. You notice the ways that the systems like really aren't set up for us to do our work or to take great care of our patients some of the time. And so that's really what sparked my interest in policy and in research. So I had really no background.

After working in a hospital, high acuity critical care, a lot of oncology, I spent several years working in community-based programs in New Jersey and this is before the Affordable Care Act. We were focused on access to medication, trying to get people more access to Medicaid, and did work around the initial rollout of the Affordable Care Act. And that experience where I spent a lot of time helping people enroll in social programs really gave me like some of the first insights into how much paperwork and how much time and how tedious it is to figure a lot of this out, even if you had someone helping you it's still challenging. And that sort of stayed in the back of my mind as I went to grad school. And really what got me interested in like all the non-medical side of patient care is just like my friends and my family talking to me about it. And I think it's something we all just experience in our lives, but there just wasn't a ton of research. And so I've really been motivated to try to put some, like, numbers and evidence beside all these experiences that we know very deeply.

Dr. Fumiko Chino: So what I'm hearing is that you learned yourself by doing the work, how difficult the work was to actually obtain services for your patients, and so you decided you needed to go upstream to try to address some of the policies that were fundamentally broken, causing these horrible situations for your patients.

Dr. Michael Anne Kyle: So well said. Yes.

Dr. Fumiko Chino: Now, I heard that you just moved from Boston to Philly. How's that transition going?

Dr. Michael Anne Kyle: It's great, it's great. Many of the same familiar faces and also exciting to meet new people, learn new things, try new restaurants. So yeah, overall I feel very lucky.

Dr. Fumiko Chino: Well, with that background, we need to dive into our actual topic, which is prior authorization. It's unlikely that anyone listening to this podcast has not encountered prior authorization in their practice or due to interactions with insurance for themselves or for their family members. Can you give me a quick overview about prior authorization? What it is, what it is not, how did we get here?

Dr. Michael Anne Kyle: Oh, so every healthcare system needs some sort of coverage policy. What services are we going to cover and at what cost? And there's many ways to do this. There are countries that sort of set this up nationally. Here in the US, we do not do that. We do it prescription by prescription, and that's how we end up with prior authorization. So basically, prior authorization is a request you submit to get approval for coverage for a drug or a service that you want to give your patient. And so you may need to submit, and again, I'm sure everyone listening knows this well, but it can range for something very quick like, "Yes, this person has like the genetic target for this drug. Check, they can have it," or it can be a more complex, protracted exchange. That is the sort of intellectual side of this. And I want to separate that from like the actual decision making from the other huge piece of prior authorization, which is how we operate it. And that is the bureaucracy and the fax machines and the time on hold, which has a separate bucket of problems. And so I just want to sort of carve out those two categories when I think about prior auth and what we need to do.

Dr. Fumiko Chino: One thing I always try to say is that even with prior authorization, even when it is working as functions, it is itself not a guarantee that a claim is even going to be approved. You can obtain prior authorization and then still face a denial for the actual claim, which is even more frustrating. And I think this kind of cumulative burden of suffering seems to me to be at an all-time peak. So can you give me a little bit of background about how the US healthcare system evolved to include prior authorization? Like why does this really even exist?

Dr. Michael Anne Kyle: Great question, and you'll get a different answer depending on who you ask. But overall, we need as a society to make a decision about the services that we are going to provide to one another. There's many different elements to that decision. One of the challenges in the United States is that we have little to no policy around cost. So when our healthcare can cost an unlimited amount, that makes it higher stakes and a trade-off is that there can be other restrictions on access. So we really don't have any constraints on cost in the U.S. other than administrative tools like prior authorization. And so that leads us to use it, I think, in ways it wasn't designed for, because there is a clinical use of prior authorization that's very appropriate, that we are doing complex things with patients that may or may not be a good fit, and we really want to figure out if this is the right match.

That is separate from healthcare is very expensive and unaffordable and we have no way to try and solve that problem except to try and put more restrictions in place, like making people go through a bunch of approvals and either discouraging them from going through that process or, you know, causing attrition through the process.

So I think one big element to how did we get here has to do with healthcare being very expensive and I think that dominates our minds. And I think there are other rationales for prior authorization that are very appropriate. But I think to your point, it's hard right now to see the times where it makes sense to go through this review process because so often you're experiencing prior authorization for treatments and medications where it just doesn't make any sense.

Dr. Fumiko Chino: One thing I've heard you speak before about is the Medicare Part D protected status that requires coverage for all or substantially all of drugs in the anti-cancer therapy treatment. Do you mind speaking a little bit about how that affects utilization management?

Dr. Michael Anne Kyle: Yes, great point. So one of like the most strictest restrictions you could put is exclusion - so you could just not cover a drug or a service. And we often don't think of that as a coverage restriction, but of course it is. But as you said, there are certain types of treatments and services where we have put in place policies to prevent exclusions because we thought these were important treatments and we didn't want them to be excluded from coverage. And in the Medicare program in Part D, which is the outpatient drug benefit, there are several categories of medications that are protected classes, and one of them is oncology drugs. So that means oncology drugs cannot be excluded from the Medicare Part D program unless there's a substitute. Like for example, if the drug goes generic, you could just cover the generic, but otherwise you have to cover everything. So that means that the only mechanism available to try and influence decision making and influence utilization is prior authorization. And that, I think, contributes to why we see such tremendously high rates of prior auth in oncology drugs in particular.

Dr. Fumiko Chino: So you're saying that a policy that was put in place in theory to help protect people with cancer may actually be placing disproportionate burden on them?

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Ironic.

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Virtually all patients and providers that I have talked to have felt like prior authorization has gotten worse in the last five years. Is this just a feeling or an emotion or does the data support that we're dealing with higher prior auth burdens more than ever before?

Dr. Michael Anne Kyle: Yes. So I think one reason prior authorization has come to the forefront of people's attention is because the prevalence is increasing. The reason for that seems largely to be driven by some larger changes in coverage, notably increase in managed care. So most of the Medicaid program is now in Medicaid managed care. In Medicare for older adults, Medicare Advantage is now a huge proportion of that program. So as managed care coverage becomes more prevalent, with that comes more utilization management tools. So then you face it more and more in your clinical practice and for your patients. So that's one major driver. And then the other thing is that as the cost of drugs goes up, so does the effort to contain costs.

Dr. Fumiko Chino: The downward pressure for cost management.

Dr. Michael Anne Kyle: Exactly.

Dr. Fumiko Chino: Now, you said managed care. And I just want to clarify for our audience, when you say manage Medicare or managed Medicaid, what do you mean?

Dr. Michael Anne Kyle: Thank you for reminding me to clarify. So in the sort of classic Medicaid or Medicare programs, or how insurance used to be when those programs first started in the 1960s, is, you know, you would like get your insurance card and you can just go around to anyone who takes that insurance. Managed care is just like a more active type of insurance where you'll have like a defined network - these are the doctors who are in your plan that you can go see, otherwise, you have to go out of network or these are the services that are covered, or these are the drugs that are covered. So managed care basically means the insurance company is taking a much more active role in the design of the benefit and so then that's why you'll see more utilization management.

Dr. Fumiko Chino: So instead of, for example, straight state Medicaid, which would be a state provided, federally funded plan, it's a private company who's actually providing those services through a contract through the state.

Dr. Michael Anne Kyle: Yeah.

Dr. Fumiko Chino: And similarly for Medicare Advantage plans, it's a private company who has decided to take the money from the federal government and then ends up providing your health care as someone who's over 65 who signed up for an MA plan.

Dr. Michael Anne Kyle: Yes. And there's two reasons that contracting ends up happening. One is that it's easier for budgeting purposes for the state, just kind of like issuing a contract. But the other thing is that states don't have the capacity to administer complex benefits. And so there aren't really like people to implement prior authorization or this type of complexity, like in the government itself. And so that's why we tend to see these kinds of practices more in insurance companies.

Dr. Fumiko Chino: Yeah, I was shocked. You know, one of the great wins of the, for example, Affordable Care Act was expansion of Medicaid, which seems great, you know, to provide health insurance to more people. But then along with that came the rise of the managed Medicaid programs, which is essentially, it sounds like states kind of got overwhelmed and could no longer manage their patients on Medicaid. Does that seem accurate?

Dr. Michael Anne Kyle: I think there's a couple of things. So one, this is the time period when I was still working in a lot of like, on the ground Medicaid public health work. So Medicaid expansion happens like still kind of in the aftermath of the Great Recession. So there had been tremendous layoffs in like, reductions in state capacity, while at the same time there was this huge expansion and like their scope of work. And so I think like a lot of the reason that managed care arose was that like they're just, you know, there had been these huge layoffs and there weren't people left in the Department of Health or in the Medicaid office. And so it was necessary to bring in external partners because the government had been understaffed.

Dr. Fumiko Chino: It's such a good point. I actually love this little bit of history you taught me because I'm always trying to tie the red thread to the red thread. Like this policy led to this either benefit or deficit. And I think, you know, stepping back one click further to say this was the environment in which these policies were enacted is so helpful when we put these things in context. It has like the benefit of talking with someone who's really a policy expert, that really helps me understand these things better.

Now, most of the data on prioritization has been really physician survey data. It shows that we hate it, it wastes our time, it increases staff allocation, it causes endless frustrations for us. Now, your work has mostly been focused on the burden on patients. Can you share what research has shown about this?

Dr. Michael Anne Kyle: I decided to focus on patients because there was just no evidence. And so there's not a ton, but there is some evidence about the experience of physicians, and everything you said is spot on. But my work finds that like you think that the pie is just what the physicians are dealing with or what the health system is dealing with, but actually like the pie is even bigger because there's this whole other chunk of work that patients are doing that we haven't really accounted for. Because of course you are spending your time after hours on hold, doing peer to peers, but at the same time, like letters are getting sent to the patient's house and they're trying to figure out what does this mean and they're also making phone calls, trying to understand what happened.

So I started this work with a national survey of adults 18 to 64 who are insured. This is just like people off the street, like not necessarily any particular health issues. And 1 in 4 people said they had delayed or foregone care in the past 12 months due to an administrative barrier. And one of those barriers was prior authorization that patients reported. And the structure of that question is the same as the way we ask questions about access barriers related to cost. And so the magnitude of barriers related to these administrative burdens is about the same as the barriers that people are reporting related to cost. And I think that's really important because we all have this sense that it's a hassle or a problem. I think it's only recently that we're understanding that it's not just frustrating, that it actually really does affect access. So that was like one step.

Then I have another piece of work building on that where I thought, okay, so patients are reporting that this is a problem and candidly that's sufficient because they're stressed and they don't feel well. But I looked at oral anti-cancer drugs and said, "Okay, like can we observe in data this phenomenon that patients are reporting that they're having issues with delayed and foregone care?" One of the challenges with claims data is you only see the claims that got billed. So we can't even see the people who got a prescription and never filled it. And I'm sure that you have many personal experiences of that with your patients and so do many of the people listening. But I'm not even able to see that in claims. So I just looked at people who were already taking a medication, already taking an oral anti-cancer medication. So we think, "Okay, they're consistently filling it so we know they're like on this regimen, and then their plan introduces a new prior auth policy on that drug and what happens to them?" And we find that people do experience delays in foregone care, that people with a new prior auth introduced on this drug they were taking have an average of a seven-day delay in their next fill after the prior auth, and that they have about seven times the odds of never filling that again. And this is for people, remember they're already taking this medication, which means they're connected to care, they have a doctor who's following them and there are policies saying in Medicare, and so this is in the Medicare population and there are Medicare policies which say, you know, you're supposed to just like roll people into coverage. If they already are on this medication and there's a prior auth, you're just supposed to continue and not impose a new prior auth on them. And that may be true, but in practice that policy isn't working because there's a delay of some kind.

We don't really know what's happening in that time. We just know there's a disruption. And whether it's because they have to do a prior auth anyway or they found out they didn't need a prior auth, the point is like there's an administrative barrier that's arising for people who are then not taking their imatinibs, not taking their erlotinibs, not taking their abiraterone. So like it's really concerning and that does not get us to health effects. One of the challenges in studying health effects is that the sample sizes get smaller and smaller and it's hard to attribute outcomes, especially for people with complex illnesses, to like one particular event or one particular cause. So that's something that sort of remains on my bucket list and hopefully on other researchers' bucket lists. But I think that you as a physician and the other people listening get a contextual sense that these are drugs that you really shouldn't be going off without, like a planned clinical reason.

Dr. Fumiko Chino: You know, the research that you just discussed was published last year in JCO, and I remember when I was talking to you about the study that you said something along the lines of you couldn't do an updated analysis now because this was a plan that didn't have a prior auth, that now needs a prior auth. And so you were looking at these transition points, whereas, by the end of the study period, basically every single plan had prior auths.

Dr. Michael Anne Kyle: Yes. So that study we looked at data from 2010 to 2020, I believe, or 2021. But most of these switches of like introducing new prior auths were happening in the first five years, usually before 2015, 2016. So I was trying to look at newer drugs like you said, but they're all coming onto the market with prior auth, and I can't study the new stuff because there's no variation to study. So thank you for mentioning that.

Dr. Fumiko Chino: So you can't document the harm of prior authorization because the best case scenario of no prior authorization doesn't exist.

Dr. Michael Anne Kyle: It's getting rarer and rarer for the oral cancer drugs, that's for sure.

Dr. Fumiko Chino: Now transitioning a little bit, there were many people, myself included, that were anticipating that prior authorization reform would make it into the lame duck session closing out 2024. Do you have any policy updates or insight into this?

Dr. Michael Anne Kyle: So I think the updated Improving Seniors' Timely Access to Care Act, I've been following that for a couple of years and I think the latest iteration is quite good. It really focuses on these, like, administrative improvements that I think are really an urgent priority because there's no reason that we need to be having all these hassles with paperwork in 2025. I just want to mention this bill includes actual phrasing like a facsimile does not count as electronic documentation. And I was thrilled to see that.

So what I like about this bill, and I hope it will survive and endure, is that it speaks to a bunch of priorities that I think are important. One, everything needs to be automated or everything needs to be electronic. We're still doing way too much fax, way too much paper. The bill doesn't mention whether the electronic requirement includes appeals, and it really should. If I was going to have one strong piece of feedback, it must, because I'm concerned that if we make the initial application process online, it'll just get denied and then appeals will be on paper and then we'll be back to square one. It also will really increase reporting and data access which will be helpful. One of the challenges in studying prior auth is that it's hard to get good data. Like I said, claims data, we only see things that were billed. We don't really have a great sense of payer policies. And this bill would require reporting from payers to say like what their prior authorization requirements are, denials, appeals, grievances and so on, which will be very helpful.

Although I want to highlight on this point, there's some new work on billing, which I don't think will come as a surprise to any of us that there are unfortunately inequities in the appeals process. And so this is work by Alex Hoagland and Michal Horny and colleagues and they looked at preventive services which are supposed to be covered under the Affordable Care Act. So you have some like objective sense of what the bill should look like. And they look at errors and then they look at appeals. And there are inequities by race, there are inequities by education and income in who is even appealing an erroneous bill and then how successful you are in appeal. And so while I think more transparency throughout this process is great, I remain concerned that like relying on patients and physicians to recognize and initiate appeals places disproportionate burden on our patients who can least afford it.

Dr. Fumiko Chino: I was personally very disappointed that the Improving Seniors' Timely Access to Care Act, which is the world's longest House and Senate bill title, wasn't part of the end of year spending package. I was really hoping we could pass it through the finish line, especially because it has a zero-cost dollar from the CBO, which was a major point of resistance before. And I know this is something that both our ASCO and ASTRO, our large societies for oncologists, have really been trying to rally support around consistently and it really does seem to have bipartisan support.

So outside of federal legislation that did not make it into the spending package, how do we fix this? You know, I was rereading your New England Journal of Medicine 2023 Perspectives, highlighting some potential consequences and barriers to prior authorization reform. Can you discuss this as well as whatever specific federal, state, institutional policies or even really provider level advocacy that you feel like could get us out of this mess?

Dr. Michael Anne Kyle: Sure. I still have hope for the Timely Access to Care Act because it's been kicking around for a few years and it keeps getting worked on, improved. So hopefully 2025 will be our year. The perspective that you're talking about refers to a CMS rule that at the time was open for comment but has since been passed and is scheduled to sort of go into service in 2026, 2027. And that incorporates a lot of the same elements as the Timely Access to Care Bill. So for example, it requires that these processes be electronic. Again, the question of appeals is a little bit vague, but making them electronic, requiring the reason for denials to be provided, providing paperwork to the patient and to the physician about the status of the application, and if it's denied or has a problem, why. There's a whole like IT element of this where there's a patient portal piece so that patients would also be able to log in and track the process themselves. On the one hand, I think that's nice for people who want to, you know, follow along. On the other hand, you know, if you don't feel well with cancer, ideally this should be getting addressed without you having to log in and check up on it. You could be like resting, recovering, enjoying your family. But overall, I think there's an understanding that we have to move away from this very analog process that we have now. So that I guess is going to come online starting in about 12 months. And then there's a bunch of work going on at the state level. Some states are requiring electronic PA, which I think is terrific.

Throughout these bills, there's also some time deadlines on these decisions. So I think having a turnaround time, whether it's like 72 hours or seven days, whatever it is, I think it's good to put those into place. I worry about an unintended consequence will be that if they can't meet the deadline, they would just deny it and you would go to appeals. And again, coming back to my fixation on like, what does the appeals process look like, but I think overall it would be very helpful to have some like, better definition and better clarity.

One thing I haven't seen in these, but I hope that policymakers and advocates will become interested in is I would really like to see some more standardization of these forms across payers. Obviously, the dream would be like standardization and actually like the parameters. But even if we can't get there at least like the paperwork could look the same because there's a lot of duplicated effort in filling out the forms and submitting these. This is really unnecessary, like it should all just look the same. And we keep reinventing the wheel which slows everybody down. And I think there's a huge policy opportunity there to promote standardization that if we have to do this, like at least it could be less painful.

Dr. Fumiko Chino: Absolutely. And I always try to highlight when I think about state level legislation, things like Gold Card Acts to my knowledge have not included any cancer services as part of what you could be gold carded for. At least not, again, not that I'm aware of at the various states where they have passed Gold Card legislation, which is a promising way of facilitating approvals. But so far, cancer patients are still kind of left out of that. Have there been any institutional policies that you've noticed seem like they help with prior authorization?

Dr. Michael Anne Kyle: No. And I think a lot about my research, like who my audience is and its organizational leaders and policymakers. And I would really like to see clinical organizations advocate for more standardization and more process improvement. I understand the emphasis on like we don't like prior auth and we want less, but I think there's an easier win in asking for this system to work better. And I'd love to see some of our health care organizations put their weight behind that.

Dr. Fumiko Chino: I have to say, since transitioning institutions to MD Anderson, I've actually been very pleasantly surprised within our radiation oncology department how streamlined the process is. And I think it's because we had a motivated faculty member who went deep into the prior authorization process and why the plans were being denied, got all of the constraints that would trigger an approval and basically built them into our planning process. So it's been really streamlined, but it was a lot of investment upfront to kind of get it to the point where it is now.

Well, I think we are wrapping up our time together. Do you have any last thoughts about prior authorization or have what we already said has it been disappointing enough?

Dr. Michael Anne Kyle: Well, let me finish on a positive note. I think what's exciting about this is that we've spent many decades on trying to improve the cost challenges in healthcare. We have the Affordable Care Act. I don't think we've yet put the same effort into non-financial costs. And so I think there is a lot of hard, hard stuff ahead. But I think there's also a lot of these challenges I think exist because no one has looked at them yet. Like how much prior authorization is like a strategic decision? And I ask this to everyone, how much is it of it is a strategic decision versus how much is like the manual is lying in someone's cubicle and hasn't been updated in years and if only someone with decision making authority looked at it, they would be like, "Oh, yeah, you can take prior auth off it"? You know, like, I just think that there's a huge opportunity to do better here because we haven't paid it enough attention. So I think we should be hopeful and I want to do better for our patients. Like I want to feel prouder of the healthcare system that I'm a part of.

Dr. Fumiko Chino: 100%. No, I love that. And that's a great hopeful end, which is that with data maybe we can start to work our way out of this. And so that's maybe a siren call for researchers coming online to think about galvanizing yourself to provide data as to what we can do to improve.

Well, thank you so much for such a robust conversation today about such an important topic. So many thanks to both Dr. Kyle and to our listeners for your time today.

For listeners that are interested in advocacy, I would encourage you to visit the ASCO ACT Network where you can send pre-drafted letters to your lawmakers on important legislative issues impacting cancer providers and their patients, things like prior authorization.

You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put Into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. I hope that you'll join us next month for our next episode. Until then, keep fighting the good fight for our patients.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Guest's Disclosures:

Dr. Michael Anne Kyle
No relationships to disclose.

Dr. Pennell talks with Dr. Sushil Beriwal about guideline variability and how care pathways might play a role even in situations where the best practice seems clear.

Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the Journal. The best available evidence for cancer treatment seems to change at just a staggering pace. And yet, as physicians, we're expected to keep up with these changes and always give the most evidence-based treatment, which is obviously an incredible ongoing challenge.
Guidelines from major organizations can play a role in helping us stay up to date. However, considerable variability exists, even in situations where the best practice seems to be clear. This creates an opportunity where things like care pathways might play a role.
Today, we're going to be talking about this topic and about a new paper titled "Lag time between evidence and guidelines-- can clinical pathways bridge the gap?" which will be published in the March 2019 JOP.
Joining me today for the podcast is the senior author of the paper Dr. Sushil Beriwal, professor of radiation oncology at the University of Pittsburgh and deputy director of radiation services at UPMC Hillman Cancer Center. Dr. Beriwal, thank you for joining me today.
It's my pleasure. Thanks for having me.
So why do you think there is so much variability in care, especially around things where a lot of people have broad agreement? So the example in your paper that you use is hypofractionated whole-breast radiation, which has been part of a major guideline since 2011. And yet, it seems as though many people don't use it.
So we do see variability in the cancer care. And hypofractionated radiation therapy is one of a good example. What is exactly? It's hard to pinpoint. But I think it's for multiple reasons. Could be a physician is used to practicing a certain why. They don't want to change the practice. They're not aware of the newer data and guidelines.
Or it could be the fact that they're concerned about increased side effects and toxicities with this newer approach. They may not have technology or resources to do it. And last, but not the least, sometimes the fee-for-service model may have a detrimental effect in accepting a shorter course of treatment.
Oh, I hadn't even thought of that, but that's a good point. So can you take me a little bit through your study? What was the problem that you were trying to solve?
As you know, there have been various studies which have come out in the last 5 or 10 years, looking at adoption of hypofractionation for breast cancer care, even though the randomized data suggests that hypofractionation is similar for cancer outcome and possible less side effects, [? with ?] the adoption rate based on the National Cancer Database analysis, or some keyword industries, or some state data, it's somewhere within 10% to 50%.
So there is wide variation and acceptance and adoption. And we were trying to figure out a way to make it more uniform so the patient get similar kind of care based on the best available evidence for that patient.
Is care pathways or clinical pathways something that you've had experience with working with before? And I guess, maybe just for our listeners, kind of explain to us what a clinical pathway is.
Clinical pathways are like additional [? aid ?] tool which basically guides the physician to decide about the care of the patient based on the stage, grade, and other factors associated with that patient. So we at UPMC Hillman Cancer Center started the clinical pathway in a very rudimentary form about 14, 15 years ago. It has come a long way from being a paper trail to an electronic format.
The way it works out is anybody who sees a patient in our network of 25 sites has to enter a decision to-- in the care pathway model created by this company called Via Oncology, which was initially part of UPMC, but this year, it was bought by somebody. Well, it was an outside company called [INAUDIBLE].
So say, for example, if I see a patient in my clinic, I go to care pathway website. And automatically, it will ask me for stage, grade, and what needs to be done. And then it gives me the option of what to do. So if the option for that patient is hypofractionated radiation therapy, that's what I have to choose.
I see. And how do you decide what goes into these care pathways? Is this determined by an outside group? Is this something that you get to determine within your own institution?
When we started, it was within our own institution. But now we have oncologists from all over the country who participate, who are part of the same care pathway module. We have chair and co-chair for each site. And we have committee members for each site.
So we meet every six months on a regular conference call. And whatever evidence has come out in the last six months, we try to incorporate that in our discussion and make changes accordingly. So initially, the agenda is discussed. The committee decides and discusses. It goes back and forth.
And once the committee agrees, then it's sent out to all the members for voting. And once everybody agrees in the voting, then it is implemented. And that becomes the care pathway for that disease and stage.
And so what were the results of your intervention?
So we went by a very stepwise manner. So initially, the 10-year data for hypofractionation from the UK group came out in 2013. So when that came out, we as a group decided to mandate hypofractionation for somebody who is 50 and above, like postmenopausal women with early-stage breast cancer. When you're trying to keep breast or just [INAUDIBLE] level to use.
And we found when we assessed the outcome that there was a very high acceptance rate of hypofractionation. But one of the concerns we found that the physician had in accepting hypofractionation was how best to do it, because those papers and the data did not define fully the best way to deliver the dose, how best to achieve dose homogeneity, what should be the [INAUDIBLE] and the hard dose.
So within our own network, we came up with a very good guideline of how best to achieve dose homogeneity to deliver this dose safely and make it better for the patient. Once we got success with that, then we took the next step of implementing this for younger women.
And since we already had the track record, we found that the resistance to the acceptance of hypofractionation was much-- there was much wider acceptance, because people knew how to do it from the previous experience. And the acceptance was much more wider and much more-- the numbers were close to 95% to 100%, which was very reassuring and which was very gratifying to see that patients across our network were getting similar kind of care.
No, actually, the numbers are staggering. I mean, in 2015, the number was only 4.2%. But by the second intervention, you said it was 96.5%. So were the doctors actually mandated to use this? Did they have the option of changing it if they wanted to?
So the way our system works is the only option we had was to do hypofractionation, but they can change it. But they need to have an evidence-based discussion of why they want to change it.
And see, I'm department director for the breast. So anybody who wants to do something different, then he will send an email to me, that he doesn't agree with the pathway recommendation. And these are the reasons why he wants to do it. If the evidence-based discussion is consistent, then we say, go ahead and do the conventional fractionation.
Well, it clearly was very effective. I'm curious if you saw pushback from the doctors in making this change? Did people have a problem with being directed towards this particular treatment?
Initially, I did. Initially, when we did it for the first time, there was a lot of communication back and forth. And people made different kind of arguments, like we only have 10 years' data. We don't have 20 years' data. And we don't know whether it is safe or not.
Or [? they could ?] quote previously have done studies which have shown poor outcome. But they were done with different techniques and different philosophy. So there were a lot of discussions back and forth. And to alleviate some of the concern, I did a [INAUDIBLE] conference in our network, where we mandated all of our physicians to participate and listen to the [INAUDIBLE] conference, where we defined how best to do hypofractionation in terms of dose homogeneity, in terms of heart and lung dose.
The most important factor was dose homogeneity. And once physicians understood that the dose homogeneity is the more important component than the fractionation, and they could see the results from the patient's perspective and from physician's perspective, the adoption became like a no-brainer.
The other thing that is remarkable to me about the pathways at the University of Pittsburgh and the people who use the Via Oncology Pathways, so my own institution at the Cleveland Clinic, we also come up with our own evidence-based care paths. And we try to educate people about them. But there isn't really a good way to track how well people adhere to them.
How important do you think having the web-based monitoring, where people actually have to track what they're doing, is to adherence to these care pathways?
Well, it definitely helps us, because there are two ways we monitor it. One is like the [INAUDIBLE] tool. Then anytime you go off pathway, it comes to the pathway director as an email for him to respond to the rationale behind our pathway and whether he or she agrees with it. And if he agrees with it, then it goes into the system as "On Pathway," even though the track was not on pathway.
And the second thing is you may say you're doing something, but you may not be doing it. So we have an audit system built in where we have one of our staff members audit the charts randomly across our network and match what has been done to the patient to what has been entered into the clinical pathway, to make sure they match.
If other centers wanted to start adopting clinical pathways in order to help improve the quality of their care, what are some of the take-home lessons you learned during this process that you can pass on to them?
I think it's important that you have the buy-in from the providers. So in our pathway, it's not like the total is 1% of [INAUDIBLE]. It's a committee, it's a member, and it's an open discussion. If you don't have the buy-in from the people, then it's hard to implement it. You need to explain to the patients it's not taking over their autonomy. The physicians still have the autonomy. It's just helping them guide better to have uniformity of care.
And having some-- there are system guidelines. And there are other guidance available. But they try to keep it very lighter in terms of options. The difference between the guidelines of the pathways is there's much more [INAUDIBLE].
Like, for example, we call it the philosophy of efficacy, toxicity, and the cost. All things being equal, the one which is most efficacious gets number one ranking. If it is equally efficacious, then the toxicity gets the high ranking. And if it is equally efficacious and toxic, then the cost gets the high ranking.
So the hypofractionation for the breast, it's similarly in approximation to efficacy to [INAUDIBLE] fraction. The toxicity is somewhat better with hypofractionation. And the cost is much better.
I think that's a critical point to illustrate, that the first and most important thing is that we make sure that it's just as effective and also at least as tolerable, if not better. We want to make sure people understand that the clinical pathways such as this are not designed just to save money but also to improve actual patient care. And what are the next steps? Where are going from here?
So just to take this concept to the next step, like we have recently adopted hypofractionation for prostate cancer. And we have implemented in our data our guidelines how best to do it. So our next step is to look at the adoption of hypofractionation for prostate cancer, which is like nine weeks treatment versus six weeks treatment, with the guidance of how best to do it.
And the next thing we'll be executing is whether we are able to successfully do that or not for prostate cancer too. I think this has given us a benchmark and a platform to take it to the next level for other disease sites, and to make sure that we are following the data and evidence to the best of what we can do.
Thank you for agreeing to talk to me today. I think this is going to be really of interest to the listeners of the podcast.
Thanks for having us. And it was a pleasure talking to you. And I hope that this can send the right message to the audience for them to take these steps in their own practices.
I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on December 7, 2018, and will be in the March 2019 JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice, signing off.

With the care of patients with cancer strewn across numerous settings, are electronic health records (EHRs) meeting the definition of interoperability according to the 21st Century Cures Act? Dr. Pennell speaks with author Wendy Rubinstein.

Read the related article "CancerLinQ: Cutting the Gordian Knot of Interoperability" on JCO OP.

Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Most oncologists in America today use an electronic medical record, or EMR. But for a number of reasons, few of us are able to access records for patients outside of our own practice, a concept that's known as interoperability.
Today we're going to be talking about a new editorial published as part of a series called "The State of Cancer Care in America." This editorial is titled "CancerLinQ-- Cutting the Gordian Knot of Interoperability," published in the January 2019 issue of the JOP. Joining me on this podcast is the author Dr. Wendy Rubinstein medical geneticist and Deputy Medical Director at CancerLinQ, LLC. Dr. Rubinstein, thank you for joining me today.
Thanks for having me.
So I know that this is not going to be a surprise to any of our listeners, but would you mind just kind of giving us a little background on the issue of EHR interoperability, and how did we end up with the scenario that we have today?
Well, sure. Of course, electronic health records systems weren't built with interoperability in mind. The overarching goal for hospitals was documentation to support billing, and it hasn't been a priority for hospitals to make it easy for their patients to interact with other health systems. But to be fair, people didn't talk much about interoperability 10 to 15 years ago. And I'm not even sure an official definition existed.
So now the 21st Century Cures Act provides a definition. So basically, electronic health information should be able to be securely exchanged with other health information technology. And there should be no special effort required by the user, especially and including patients. And the data exchange for the authorized use, it needs to be completely enabled under applicable laws, and any information blocking is prohibited.
So what this comes down to, basically, is that a patient should be able to have care at one medical office, and then go to a separate system across town, without having to fill out another paper form with their complete medical history, medication list, and review of systems all over again. So part of the article talks about, and you mentioned, the ASCO Oncology Practice Census. And in 2017, the practice census found that 40% of practices were unable to accept any patient information from other practices.
And you might think that the problem is getting better with attention to it, but actually, it's getting worse. In the 2016 practice census, 34% of oncology practices said that their EHR was interoperable with hospitals in their region. But in 2017, only 10% were interoperable with regional hospitals. So in oncology, this is especially important because cancer patients typically have their care strewn across multiple specialists, surgery, radiation oncology, medical oncology, and more. So with their care being decentralized and being complex, how can we really subject our patients to recounting their entire history every time they come to a new specialist?
And we're relying on them to be savvy about their cancer history and to be accurate about it. And this is often the worst time of their life. So without quite saying it to them, we're basically letting them know that we don't communicate with our other doctors. And I have to say, sometimes my own medical profession embarrasses me.
Yeah, it's interesting. I mean, it's a couple of different issues, the first being of just simple interoperability and having access to your patients' records when they're not within your system. The traditional way of doing this is you've typed up a letter or a note from what you've done, and then you mail it to the other physicians who are either the primary care doctor or the person who referred to you the patient. And strangely enough, that's still mostly how this happens.
I have a sophisticated electronic medical record that puts together a sophisticated note filled with all kinds of important information, which gets printed out and put it in an envelope and mailed to someone, rather than sending that electronically and having it available whenever they need it. They have to somehow come up with a way to scan that into their system so that they can read it. So it's really remarkable that we're still in that system. And I now have limited interoperability with other people through my own EMR, and it's just astonishing how much easier it is to keep track of people with that. Once you start to get a taste of the potential of that, it's really hard to go back and not be able to access patient's records anymore.
Everyone I think is a little bit aware of this issue and becoming increasingly aware of this issue. What are the barriers out there to making EHRs interoperable? It just seems like such an obvious thing to do, and yet it somehow is a difficult process.
To attempt to maybe take something complex and bring it to some basic issues, I can call out a couple of issues. One is extreme customization, and the other is that we need a common language that can speak across different implementations of electronic health records. So with extreme customization, and this is how I would characterize it. So customization is very effective at locking up health information and preventing it from being exchanged. And for any EHR vendor, offering a way for clinicians to customize their reports, their documentation, it really is a great way to satisfy them.
And in fact in my own experience, my cancer genetics practice became very efficient by creating templates for notes and letters about genetic testing and managing patients at high risk of cancer. But if you think about it, when I recorded a diagnosis of colon cancer in a letter to the patient or the clinician, it wasn't mapped to any standard vocabulary or code. It can't be shared other than as a TXT file.
When you talked about bringing in scanned documents, yes, you can look at them, but they're not machine computable. In fact, if you like to know how many ways you can say total neutrophil count in an electronic health record, CancerLinQ was in the unfortunate position of figuring this out. So in the first 30 oncology practices that CancerLinQ received data from, there were 76 distinct ways to say total neutrophil count, like white blood cell count or WBC. And that means that there were more than two names per organization on average, even within an organization. There's no agreement on what to call this.
So it's certainly true. We, as human beings, we can all semantically process different terms for total neutrophil count, but a computer can't. It can't do that, unless we provide a mapping or we create it. So this basically locks up the data and reduces its value. So to extract the value, we apply natural language processing and human observation using interfaces. But that's expensive, and the problem is it doesn't help at the source. You still have the EHR, it's not really aggregated together yet, and in the day to day workings, you're not really doing anything to solve the problem.
So the other problem which is very much related is we need a lingua franca. We need a common language to make the proper use of the data that we have in EHRs. And so on a higher level, ASCO and CancerLinQ have convened a volunteer stakeholder group, and this represents diverse perspectives in oncology, different specialties coming to the table. And the purpose is to create a core set of data elements from oncology called mCODE.
So mCODE stands for Minimal Common Oncology Data Elements. And ASCO is aligned with other medical organizations, as well, and the Biden Cancer Initiative, so that together we can inform oncology EHR vendor design. We can inform their decisions and, hopefully, prompt interoperability to improve cancer care.
One of the things that's-- of course, you now work with CancerLinQ. Can you tell us just a little bit about CancerLinQ and how CancerLinQ can work to overcome some of these issues?
Sure, I'd love to. So CancerLinQ is a major initiative at ASCO. And the goal was to create a learning health system for oncology. So first and foremost, CancerLinQ is a quality measurement and reporting system. We have over 100 health care organizations. These are large and small, they're community and academic, that are participating in CancerLinQ.
And so far, we've established data flows with 47 organizations, and we've integrated data for over a million patients with cancer. And that reflects their comprehensive longitudinal record of health. So by doing this, the reason to do this is we're enabling practicing oncologists to measure, and report, and improve the quality in patient care.
So when you look at, for example, the 2017 ASCO Oncology Practice Census, about 25% to 30% of practices, they called out quality measurement and reporting activities as a top burden for them. In order for them to do this, they have to actually do manual extraction from electronic health records, if you can wrap your mind around that. You have to pay to do that. So the CancerLinQ platform reduces the reporting burden by displaying the quality measures for MIPS, MACRA reporting and also supports ASCO's QOPI certification.
And what this means is that clinicians can actually see the time window they have left to take specific actions to meet the quality benchmarks. The other part of CancerLinQ is that we provide statistically de-identified data sets from the cohort to researchers and to FDA. And in that way, we're trying to accelerate discovery and scientific improvements to cancer care.
Yeah, it's a fantastic initiative, and I'm glad to see that it seems to be growing and doing well. The next question would be, how can CancerLinQ, aside from individual practices being able to use the data for quality metrics and, of course, the anonymized pool data for research, how is this working to overcome problems of interoperability?
So CancerLinQ is somewhat unique in that we've integrated data from practices, so far using seven different electronic health records. So we don't limit, we feel we can't limit the data aggregation to a single EHR type because the overall goal is to learn from all patients. But there are some common problems that we share with other big data providers. So any entity that's performing data aggregation, they're also coming up against the same problem we have, as needing a common language for oncology, such as mCODE.
And as I mentioned, ASCO is looking to engage everyone who has this common problem to solve it together. One barrier I can't resist talking about as a geneticist is the way genomic data is handled. The one disturbing practice is that really the way DNA sequencing data exists is it's completely structured in machine computable when it comes off the sequencer. I mean, almost by definition.
And then the results get reported by paper, and even if there is an electronic file sent to the practitioner with the report, there's nowhere in the electronic health record to store the genetic test data in its rich detail. So the report might get scanned or copied someplace, and it'll get attended somewhere where you can go visualize it. If it's scanned in, it loses all of its structure, and then it requires optical character recognition and very messed up tables to try to make sense.
So if you think about it, like what we want to do with that data, how can we automatically run clinical quality measures for colon cancer without having a place for KRAS gene test results? That's already in all the quality measures. If an oncology practice is running Molecular Tumor Board, how can they do that with reading off of this piece of paper? They need the files to really run that activity. And the same thing is true for identifying patients who are eligible for a clinical trial, increasingly based on a molecular variant result.
So we can do that to some extent. We can do all these things, but we really can't scale precision oncology with these kinds of limitations. So I think a common theme across CancerLinQ and other entities that are trying to aggregate data and especially to combine it with the rich phenotypic data in electronic health records, the molecular diagnostics laboratory should routinely make these results available to the ordering clinicians as structured data files. It may be difficult for them to maintain it themselves. The electronic health record really should have a place for this, which with mCODE, that will definitely be a part of mCODE.
Where do we go from here? How do we get from where we are today to the world where all this information is easily shareable across EHRs?
The technical challenges there, but really it's about collaboration and having a will to solve this across the entire ecosystem. So we have created an organization called the Oncology Leadership Council. So CancerLinQ's Oncology Leadership Council includes corporate nonprofit and government collaborators and, for example, the American Society for Radiation Oncology, National Cancer Institute, FDA, the Cancer Informatics for Cancer Centers, Ci4CC, AstraZeneca, College American Pathologists, American College of Medical Genetics and Genomics, and many others.
Now ASCO doesn't think that this is something that we could or should solve alone. This really means helping the entire oncology community to improve care by solving the problem at the source. And that means capture all of the important oncology data as structured, computable information. And we have to do this without imposing any more documentation burdens on physicians. And frankly, we shouldn't really be hiring an army of data entry clerks to do this either.
I like to think about call to action. What can people do, given the situation? So I would like the listeners to know that the Office for the National Coordinator for Health IT is right now soliciting comments on what they call the strategy on reducing regulatory and administrative burden relating to the use of health IT and EHRs. So ASCO is currently preparing comments, and you'll have a chance to review and provide feedback. And I also wanted to let listeners know that you can also participate in the writing of comments, which is going on by the American Medical Informatics Association, AMIA. The comments are due soon, on January 28, 2019, but input would be very valuable.
I'd also like to mention that CancerLinQ is concerned about information blocking. And as I mentioned before, information blocking is prohibited by ONC. And lastly, I can't resist inviting people, that if you're interested in joining CancerLinQ, please contact us.
Excellent. I think that was a good idea to put that message out there. And I will also put the plug in that joining CancerLinQ is actually free of cost to get this wonderful resource.
You bet.
Dr. Rubinstein, thank you so much for talking with me today.
Thank you, it's a great opportunity and a real pleasure.
And I also want to thank our listeners out there who joined us for this podcast. The full text of Dr. Rubinstein's paper, "CancerLinQ-- Cutting the Gordian Knot of Interoperability," is available online now at ASCOpubs.org, backslash journal, backslash JOP in the January 2019 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Thomas Knight talks to Dr. Pennell about a major issue in cancer care: financial toxicity.

Read the related article.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. The rising costs of medical care is on everyone's mind these days. But while policymakers or physicians tend to discuss this more of as a societal or economic problem, the real consequences of the high costs of cancer care are ultimately being felt by our patients.
But how do we measure the financial burdens of cancer care? And how does this impact our patients' lives and ultimately their outcomes from treatment? Today, we're going to be talking about a new paper titled, Financial Toxicity in Adults With Cancer Adverse Outcomes in Noncompliance, published in the November 2018 JOP.
Joining me for this podcast is Dr. Greg Knight, medical oncologist at the Levine Cancer Institute in Charlotte, North Carolina. Greg, thanks so much for joining me today.
Thank you so much for having me.
So I thought this was a really interesting paper. Can we just start with a little bit of terminology? So what do you mean when you're talking about financial toxicity? I've heard people use this term bandied about. I think it's a term that oncologists are used to dealing with. And obviously, we know that health care is expensive. But this implies that there is a harmful element to this.
Yeah, sure. The term financial toxicity is still a relatively new term. We first started to use it probably around 2013. Dr. Zafar at Duke published a paper first looking at this in terms of the costs and the harm to patients. And the idea behind it is we want to be able to quantify what we're doing in terms of harm to the patient with the costs of treatment.
As oncologists, one of the things that we're really good at is grading toxicities. So we worry about nausea. We worry about neuropathy. We worry about hair loss. But one of the things that we weren't very good at was also looking at the harm we were doing to patients with the costs of our treatment.
And when I refer to cost of treatment, this term actually encompasses a lot, in terms of not just what we usually think of, which is offices, it's medications, hospitalizations, all those bills that they get from us, but there's other costs that go along with having a cancer diagnosis. Those are things like transportation, clothing, lost wages, child care. All of these things are impacting our patients. And we need to quantify this because it does have implications on their treatment and how they're going to do.
Well, that makes perfect sense. And I think that's something relatable to everyone who's treating cancer patients today. Can you give us a little bit of an idea of the magnitude of this issue in the United States? Is there existing data before your particular study came out?
There were some both small scale papers and some large database looking papers. And the general consensus was, at the time when we started this study was about 1/3 of patients are going to have severe or catastrophic financial difficulties associated with their treatment.
Wow. That's a huge number. So why don't you tell me a little bit about your study and what was the intention of the study and how did you go about it.
One of the things we really wanted to do with this study, which was part of a much larger study we had at the University of North Carolina, was we wanted to evaluate both prevalence of this financial toxicity. Because again, there had been some database studies. There had been some smaller scale studies. But we wanted to get actual patient reported data on the prevalence of this financial toxicity and in a wide variety of cancers.
But we also really wanted to look and see other things. How did it impact health services? Basically what are targets that we could intervene on to try to improve this? And so really with this study, what we did was we went into the clinics of all of the oncology clinics at UNC, and we embedded researchers in there and approached pretty much any patient that came to the clinic. Wildly successful actually, we had over 52% of our approached individuals actually enrolled in our study. And then within two weeks of that enrollment, we had interviews conducted by our staff using basically a computer assisted telephone interview.
Now as I said, this was part of a much larger project. And what we were trying to do was basically get this comprehensive database of both clinical and interview data. And then we paired that with biologic specimens and tumor tissue. However, our piece of it was we were really trying to delve down on this financial question and then look at quality of life and how it impacted their care.
Are their existing instruments that look at financial toxicity? Or is this built into existing PRO surveys?
At the time when we started this, there actually was not. Dr. De Souza at the University of Chicago actually developed the cost measure, basically posted that after we had started with us. Having said that, and I love the cost measure. I think it's a fantastic. It's a nine question survey basically looking at grading financial toxicity.
One of the things that we really were hoping to do with our primitive attempts at this was to find maybe one question things we can do in a busy clinic to try to identify high risk populations. And so with this one what we used was actually a statement from the PSUA team, which was, you have to pay for more medical care than you can afford. And then patients were asked to respond to the statement basically strongly agree, agree, uncertain, disagree, or strongly disagree. And we dichotomized them as basically exhibiting financial toxicity if you strongly or agreed with that statement, or not exhibiting financial toxicity with any other response.
That sounds like a pretty clear and straightforward question. Was there like a free form portion where they could talk about, did this affect their ability to take their medicines, or go to doctor visits, things like that?
There was. And we actually did a couple of different things. So we both did standardized questionnaires, so we did things like the fact GP, which is looking at multiple facets of patient well-being. We also looked at other health related quality of life issues. We also had developed our own access to health care questionnaire, which was looking at certain things like, were you having problems getting to your appointments? Are you being able to pay for your medications?
We did several questions about paying for lab tests, paying for office visits. And then also, we really wanted to make sure that we knew if the reason you were missing these things was because of cost, or if there were other reasons. Because obviously, we don't want to attribute this all to cost if that's not what's causing the harm.
OK, yeah. So it sounds like a lot of information gathered. So what did you find?
In our study, we had almost 2,000 participants. And we had over a quarter, so 26% agreed or strongly agreed that they had to pay more for medical care than they could afford, which is in line with other studies.
I would have thought it might have been higher than that. But it sounds like this is a nice validation that your survey was a pretty accurate instrument, even with such a simple question.
Unfortunately, what we found is that when you take this population, the population that tells us that they are having financial toxicity by our definition, what we were finding was much higher rates of noncompliance. And that was a very scary thing when you're talking about cancer patients. Our patients who had reported financial toxicity were much more likely to report needing but unable to afford prescriptions, over-the-counter medications. They were also reporting noncompliance due to cost concerns for medical care like doctor's visits, medical tests, mental health care. All these things for the majority of patients undergoing active chemo is a really scary thing.
And there's been some really good research in this area recently. There was a recent study where they were looking at imatinib and CML, and it found that individuals who had copayments greater than $53 a month were 70% more likely to discontinue within six months. So it's real world implications of this concept.
Absolutely. And were there any other factors that were associated with financial toxicity, things that you might be able to use to screen or predict for this?
In terms of the predictor, we basically validated what it had been thought of before, which is that there were certain factors that seem to be more predictive for exhibiting financial toxicity. The ones that we really know of are age less than 65 years, being non-white race, less education. All of those things had been previously described. It was nice to see with a large population model that we could validate those findings that would have been found in smaller studies. But it does seem that those patients are at much higher risk for financial difficulties.
Yeah, and the less than 65 is interesting to me. So I assume that that's probably related to Medicare coverage, that that somehow makes it less of a financial burden.
That's what it looks like. And I think that, obviously, Medicare is a nice protection for a lot of our patients over the age of 65, in that they don't see a lot of some of the costs our younger patients, especially our underinsured patients see. However, there was a recent study where individuals with cancer that were insured by Medicare alone were incurring mean out-of-pocket costs that were 1/4 of their household income. So I would say even though they have probably less bills for a lot of those patients, they're on fixed income. There is not other income coming in. So a lot of the folks over the age of 65 are still having financial toxicity even with the better insurance coverage.
Did you look at insurance coverage in this? Was that a variable in the analysis?
It was not. It was one of those things that when you go back and you wish you would have done it at the time. We felt like we had covered every single base. And it actually was a thing where we thought we were going to be able to pull that data from a database. But ultimately, we were unable to do it. It's now built into every model going forward. But we unfortunately did not have that data.
So you did a great job of identifying these patients and all the consequences of the financial toxicity. So what are we to take from this? Presumably, the idea would be to try to figure out a way to intervene on these patients. So what can we do?
Yeah, I think that, I mean, obviously, the first step is to identify the problem. And I think that that's always an issue. There's been multiple surveys of oncologists who feel it feels very wrong to discuss costs with patients. I think that we get very wrapped up in the science. And we have the latest and greatest drug that we just know is going to work. But obviously, drugs are getting more expensive plus all the treatment time and coming to and from the hospital, and basically outpatient versus inpatient chemotherapy. All these things need to be thought of when you're thinking about your treatment plans.
Having said that, once identified, if you're screening your patients for this, there are specific areas it seems like we can intervene. In our study, what we found was there were pretty interveneable reasons people were saying that they were having problems with their care. They include things like not having transportation, a lack of insurance, the inability to pay for travel. They can't take time off work. They don't have child care.
These are things that are specific issues that they're having, that with foundational support, with local and community support, you can usually intervene on. But you really do need to identify them. I know our group and the group out in Washington has done some research in the use of trained financial navigators to help patients. And that group in Washington has shown fantastic results saving a lot of money annually for these patients.
And in our group, we've also done things like treatment plans based on where you live. So can we get you treatment close to home? And if not, how can we get ride share? How can we get gas cards? Can we do things to help you?
And then also, I mean, again, there are actually a decent amount of foundational money out there if you're looking for it. There are groups out there that are there to help. But again, like I said, a lot of times, we just miss the problem.
Yeah. I mean, I know that I feel vastly unqualified to discuss costs of care with my patients. Oftentimes, I really don't even have a good idea of how much things cost. But it sounds like there ought to be a way to screen patients right up front beyond simply what their level of insurance is to see if they might benefit from these extra services. And then it's important for cancer centers to have these kind of interventions to be able to help provide with transport and identify patients who would benefit from that foundational help.
So I don't know how broadly available those kinds of services. I know we have them there. And your cancer center is actually run by our old boss, who used to run our cancer center, Dr. Raghavan. So I'm not surprised that you might have those as well. Is this something that is broadly available in oncology offices throughout the country?
It's not. I mean, honestly, it is not. And one of the things that I'm kind of one of my big pushes in terms of the research is that I think that everyone has their own issue that they're very passionate about. And I think that we could survey patients until the cows come home about different issues and try to identify patients at risk. And so one of things we've really tried to do is a couple of things.
Number one is to identify specific questions, especially in this case and some of our other studies, one or two question surveys where we can identify patients that are at very high risk for having these difficulties and identify that subset of population. And then one of the things that we're actually also working on in association with a couple other foundations and a couple of national organizations is we are actually hoping at some point to be able to start to roll out telemedicine, tele financial counseling basically and internet and other programs.
There's a pilot going on in Boston right now. There's another program we're going to be rolling out here in January, where we are trying to intervene on the problem even just from financial planning standpoint. There's a large amount of patients who it doesn't matter where you are in terms of your financial situation, financial planning is incredibly important. You could have a lot of money in the bank and good insurance, and then you get hit with a cancer diagnosis. And you're trying to figure out what you're going to do with your assets, versus a lot of our patients, which are you now can't work. And there's no money coming in. How are the bills going to be paid? How are you going to basic budget?
Again, I think this is going to resonate with everyone who treats cancer, no matter where you are. Because a big segment of our patients really struggle with this. And while it might not be immediately visible, if you dig down a little bit, it's not hard to find. Well, Greg, thanks so much for talking to me today.
Thank you.
And I also want to thank all our listeners out there who joined us for this podcast. The full text of the paper is available online now at ASCOpubs.org/journal/jop in the November 2018 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell and Dr. Schapira discuss the risks and benefits of online communities and provide recommendations for improving communication between clinicians and patients about the use of online resources.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic and Consultant Editor for the JOP. So it won't be news to any of the listeners of this podcast that living with cancer and dealing with the sequelae of cancer treatment is a terribly stressful proposition and that cancer patients and their caregivers benefit from support services and survivorship programs. Most of us, however, think of providing these support services for cancer patients in terms of in-person interventions, but increasingly, people are looking online for these kinds of support.
I suppose that's probably true for many other aspects of our lives as well. Online communities have been forming in an effort to improve access to support for cancer survivors. But how much do we really know about these communities, and what evidence is there that they are genuinely helpful?
Joining me today to talk about this fascinating topic is Dr. Lidia Schapira, Associate Professor of Medicine at the Stanford University Medical Center and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute. Dr. Schapira is also the Editor in Chief of ASCO's patient information website, cancer.net, and is a fellow of ASCO. Today we'll be discussing her paper titled Online Communities as Sources of Peer Support for People Living With Cancer-- A Commentary.
Lidia, thanks so much for joining me today.
Thank you so much for the invitation.
So first, this is obviously too big a topic for this podcast, but explain a little bit about why cancer support services in survivorship is important for cancer survivors. And I guess more importantly, where is there an unmet need, that people might need to seek that somewhere else, such as online?
Sure. So we think of support as something that is delivered in person. And certainly in traditional medical settings, we offer support, I hope, through empathic communication, through referrals to social services, through programs. We are very much aware that going through cancer alone is much harder and that support is both important just strategically to get through it but also emotionally.
I think that increasingly we also realize that people are seeking support in other ways that are not traditional and have been less well studied, and that's where the online services and supports really are playing a very important, an increasingly important, role for many patients and caregivers as well.
This is coming up actually a lot among patients of mine, especially younger patients. So can you just tell us a little bit, when we talk about an online community, what exactly is that?
So there are two words and each one is really important here. Community means, really, a group, so it's not just a one time exchange, but belonging to something, a sense of belonging to a group. And the group shares a common interest. In this case it's something related to cancer.
And online refers to where this group, or this community, meets. It could be through instant messaging. It could be through other new media or platforms. It could be through email. It could be through a website. And that is going to change as technologies change.
What we're basically saying as a way of meeting people not in person but meeting over time and through a shared expressed common interest.
And there's lots of different examples of kinds of online communities that you described in your paper. Can you tell us a little bit about them? I know that there's some that are a little bit more formal and structured and others that are really kind of left up to the patients to moderate themselves.
Exactly. And to somebody who is not a digital native, like myself, this has been a real interesting process of discovery. We tend to think, perhaps incorrectly, that online means improvised, and it's anything but improvised. A good online community that is mature, that keeps the interest of its members over time, requires some management, requires some decision, requires some effort on the part of the people who are starting the community. And so we learned that there are different types. There are different media.
Some have actually some formal facilitation with social workers and really function similarly to the way an in-person support group functions. And some are much more informal, people sort of coming together. So there are some online communities that are sort of offered through large advocacy organizations like the American Cancer Society or CancerCare. And there are others that are not, and those typically occur in spaces like Twitter or Facebook.
And now there are even some privately sponsored online communities such as Smart Patients. And we reference Smart Patients because their headquarters are in Mountain View, California, and we got to do a visit and really learn a lot about them just, again, to get a better understanding of what's available for our patients.
Well it's nice that there's so many different options. How do patients even find these? Do you know?
I think patients just find information in ways that come naturally to them. There are lots of groups for young cancer patients and survivors that have fun names, Stupid Cancer and so on, that are terrific. And there are some that are more formal through other societies. Facebook and Twitter are probably places that people go to, and they're just basically looking for others with a shared diagnosis. And so it's hard for me to answer that. It depends a little bit on how familiar people are searching for things and then what pops up when they are actually looking for something.
And one of the things that, as an experienced oncologist, I always worry about is how safe they are. I think what first comes to mind is, oh my goodness, people may be misinformed, or they may have exaggerated ideas about one treatment or so on just by asking these questions without really doing some formal research. But it's amazing actually how much good information is also transmitted through these very informal groups, some of which are absolutely not monitored. But people just really push each other to learn and to look for information in addition to giving each other support.
When we started this, the driving question that I had-- and my co-author was then a chief resident at Stanford and is now an oncology fellow. The question we had was really, are people looking for information about cancer and cancer treatment, or are people really looking to connect with each other and help each other through a difficult experience? And what we found actually is that it's both, and it was very difficult to tease out where the good information becomes also a source of support.
I would say that this sounds wonderful, and taking it at face value is probably fine. But because we are academics, we always look for data. And so is there actual data? Are there studies on the benefits and risks of patients participating in these online communities?
Unfortunately, I would say there is little rigorous data. We looked for it, and we were hoping to be able to find sufficient numbers of well-designed randomized controlled trials or other good trial designs where we could actually study this. And one of the things we are interested in is, of course, is it safe? And also, if it is helpful, in what way is it helpful?
I mean, do people cope better? Do people feel that they're better able to handle their illness, in other words? Could we find measures of self-efficacy or coping or information or something that was measurable? And we found many studies done but, unfortunately, few that were of high quality and few that were high quality and relevant to cancer. So what we found was actually not sufficient to come up with either a sound recommendation or to go a little deeper and do a systematic review or some more rigorous review of evidence.
Yeah, it's interesting. You cite in your paper a few studies that have shown some improvement, at least in things like self-efficacy and decreasing anxiety or at least perceived improvements in these, and then some that are worse and many that really don't seem to show a significant difference. Is that something that you think can change? Are there plans to do more rigorous research?
Our group has actually been very interested in trying to find the proper design for a study. And we've brought together social scientists, mental health scientists, and oncologists, and people who really understand the technologies, and we're trying to figure out how one could possibly study it. We think it needs to be done, and I'd be delighted to collaborate with others who are looking into this.
I mean, we know social media can help patients find each other or find, perhaps, centers where they're doing research. Certainly, patients with rare diseases find that it's a very useful way of connecting with others. But what we were really interested also in trying to identify how much-- what is the dose of social media? What is the best venue? Is there a way of matching a patient to group so that he or she may find what they're looking for, and when is this benefit transmitted?
Our hunch is that it's probably early on in the cancer experience that people derive the greatest benefit from feeling connected and that what actually happens is that they feel some validation. They feel better able to handle it. They actually learn how to ask better questions. But it would be wonderful if we could actually find a way of studying it. As you may well imagine, it's hard to study something that people are already doing, so finding the proper study design and population is what I think is keeping us still from being able to answer these questions.
Sure. So when you see a patient who's, let's say, just gone through surgery for breast cancer and is just embarking on her long adjuvant therapy, how do you talk to them about these resources online? How do you-- or really to all of us oncologists out there, how do we guide our patients to wade into this brave new world in a responsible and helpful way?
So for me the first step was to just recommend in my after visit summary that patients visit cancer.net as a way of getting informed. That to me was already sort of an important step. And the next step, and I'm still thinking through this, is to try to have this conversation with as many patients as I can, those were receptive to this. And as I ask them, do you feel supported, do you need a referral, I should also say, there are some online groups. Some of the times I do. It's still not part of my routine, but I bet you in a couple of years it will be.
No, that makes sense. I actually for a while was handing out to people a little card which had some responsible, what I thought were good websites, but mostly, again, for information as opposed to actual communities where they could meet other patients. So that's definitely worth some thought.
Well, Lidia, thank you so much for agreeing to speak with me today. I'm sure our listeners got a lot out of this.
Thank you so much for the opportunity, Nate.
And I also want to thank our listeners out there who joined us today for this podcast. The full text of the paper is available at asacopubs.org/journal/jop, published online in September 2018. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell and Dr. Nancy Lin discuss whether prior authorizations reduce overall health expenditures.

Read the related article "Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States" on JOP.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, we're going to talk about a topic that I think is going to resonate with just about every clinical oncologist in America-- prior authorizations.
Although these have been around for longer than I've been practicing, it really seemed to me over the last couple of years that more and more claims have been denied by insurance companies, more requirements for prior authorizations, and often for things that really didn't seem like they used to need prior authorizations, such as inexpensive medications. And now, based on data from the 2017 ASCO Oncology Practice Survey, we have some hard data that isn't just my imagination. This is a real phenomenon that is putting stress on an already stressed health system.
Joining me today to talk about this topic is Dr. Nancy Lin, associate professor of medicine at Harvard Medical School and director of the Metastatic Breast Cancer Program at the Dana-Farber Cancer Institute in Boston. She's going to discuss her and her co-author's editorial titled "The Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States." For 2018, the JOP is publishing a series of papers on the state of cancer care in America, and this is part of that series. Welcome, Nancy. Thanks for joining me.
Thank you.
I know probably most people listening to this are familiar with prior authorizations. But can you talk just a little bit about, what is the intended purpose of prior authorizations? And is this something that ever made sense before the current craziness?
Sure. Before I start, I would just like to acknowledge my co-authors on this editorial, Harvey Bichkoff, the CEO of Marin Cancer Care, and Dr. Michael Hassett, a medical oncologist at Dana-Farber. So together, we run the spectrum between academic oncologists, community practices, as well as Dr. Hassett has an interest in health policy-- so kind of running the gamut of interests here.
You know, I think we can all agree that the cost of cancer care continues to increase-- I don't think that's a controversy at all-- and that continuation along this trajectory is not sustainable in the long term. So insurers, whether they are public or private, are struggling to keep premiums down while keeping up with all the new advances in diagnostics and treatments, and many of these are quite expensive.
So, you think prior authorizations came out of this, which is that an attempt to try to maintain some cost containment in a way that, at least at the outset, the hope was that this would be in a fashion that would lead to the use of treatments in a medically indicated fashion and reduce the use of non-indicated treatments.
That sort of makes sense, doesn't it? If people are doing things that don't have a lot of data behind them or are using the most trendy, expensive test or medication, it might actually make sense to have some control to make sure that they're following some reasonable practice or guideline.
Yeah, I don't think that what is most upsetting oncologists, or oncology nurses, or front-line staff is denial of unproven or unuseful treatments. I think it's really the many and what seems to be increasing hoops that one needs to jump through in order to get testing or treatments that are really the right thing to do for patients that are really well within the standard of care.
So while the PA system might have started with good intentions, I think as it is often currently constituted-- I don't want to lump all the systems together in one. But I think it contributes in a way to sort of a siege mentality. So I think if you talk to any practicing oncologist, you will hear stories of the kinds of struggles they have had getting very standard treatments approved in a timely fashion. And while in the short term, most of us make these heroic efforts to get things approved, I think that process really as set up is really counterproductive in terms of the long-term health of our health care system.
So at the institution I work with at Dana-Farber, we tried to actually do a project where we quantified some of these kind of gestalt feelings. And so what we did is we actually looked at all prior authorizations for outpatient medications originating from the breast medical oncology practice over a six-month period of time. And we focused only on outpatient medication. So we're not talking about scan authorizations or IV chemotherapy but just outpatient oral medications, whether antineoplastic or not.
And we found that we had to process over 300 PAs over a six-month period of time and that 97% of the PAs that were requested were approved on the very first try. We went back, and we coded whether the medications were being prescribed in accordance to NCCN guidelines. And yes, most of the time they were.
And strikingly, we actually found that 15% of our PA requests were for generic medicines, like tamoxifen, aromatase inhibitors. These are medicines where there's just absolutely no debate about the efficacy or importance of the treatments. They've been around forever-- maybe not forever, but for many, many years. They're available in generic form. They're inexpensive.
And then seemingly random treatments, no matter how much we appealed, we couldn't get through the PA process. And this includes a scopolamine patch for refractory chemotherapy-induced nausea or Lupron for the purpose of ovarian suppression. And I think that when clinicians deal with this on a daily basis, they see that almost 98% of their prior auths go through the first time, that you get these sort of bizarre requests for all sorts of paperwork for tamoxifen, for goodness sakes. It really gives a sense of being besieged by paperwork and process and not really being able to see a clear benefit of the PA system. And I think that really is what contributes to this burnout and the sense that the prior authorization process is broken.
And it's not just your colleagues in Boston. I know, certainly, I've had that sensation here. But now we have some national data suggesting this is a problem being felt everywhere. I know that the most recent ASCO practice census, and maybe you could give us a little background on what that is, seems to show that this is a burden everywhere.
ASCO actually conducted an oncology practice survey. So they've surveyed about 395 practices in 2017. This actually represented about almost 60% of the US hematology-oncology workforce. So was is a pretty big survey. There were 7,200-or-so respondents.
And what was found, the key point was that payer pressures were actually the most important pressure that was felt by practices. And this was felt across all types of practices-- academic, physician-owned, rural, urban-- and that prior authorizations were actually the most commonly cited pain point, and they were cited by 78% of the respondents. So this is really something that people are feeling, truly, on a daily basis.
And this is not limited just to oncology. There was a related survey by the American Medical Association. This covered not only medical oncology but primary care and other specialties and, basically, found very similar findings. Prior authorizations are a huge burden on practices. In fact, in the AMA survey, 90% of practices reported delays in care because of PAs. Almost 80% abandoned treatment plans at least some of the time because the PA is too burdensome. So these are things that have direct effects on patients.
Oh, absolutely. And I think what was striking to me about the practice censuses, you may think this has always been a major issue, but this is a real change in the most recent year's survey. It was, I think, the third or fourth top concern of practices until this survey where, suddenly, it's now far and away the top burden on practices. And there is also some data I see here looking at quantifying the amount of time that it's taking staff and money, that practices are having to invest in trying to work around this pretty significant burden.
There are some studies that suggest that US practices spend nearly four times as much money interacting with payers than do practices, for example, in Canada, which has obviously a very different health care model. In some studies, the costs have been estimated somewhere in the $80,000 to $90,000 per 1.0 full-time FTE physician per year just to deal with prior authorization. And in the ASCO survey, the 2017 survey, the [? hema ?] practices that were surveyed reported a requirement for an average of 6.1 FTE staff to manage prior authorization. So that's a huge burden.
And I think what's important is that, more importantly than sort of the-- obviously, there's a bottom line to practices. You have to pay for these FTE. But the reality is that leaves practices to have to make decisions about how they're going to allocate their money, right? So how much are you going to support a social worker, a program nurse, a practice coordinator? How much are you going to support all of the staff required for PAs?
And what proportion of the front-line physician staff, nurse practitioner staff, PA staff will be spent during office hours-- because, often, that's when one needs to do these-- interacting with payers versus providing direct patient care? So I think that this doesn't all happen in a vacuum, and that's also very important. And when you spend money in one place, you're making trade-offs in other places.
Oh, absolutely. It's something that no one can ignore now. Do you know, is their actual data showing that all of these denials and prior auths, does that actually save money in health care?
You know, there's not a lot of information specifically looking at oncology. That's really looking at the global picture. Because if you think about it, if you don't pay for an antiemetic, you might save money on the antiemetic, but the person may end up in the hospital with need for IV fluids. And so I haven't seen very large kind of studies that are comprehensive in that way to look at the full cost of cancer care with and without various types of prior authorization processes.
That has been done in some other disease types. And in those disease types, there have been sort of mixed data as far as whether there are differences in the overall costs, for example, in the mental health area where requirements by insurers to switch from one antidepressant to another may then lead to a, for example, psychiatric hospitalization.
So there, there's been a little bit more study for that. And it does seem, at least in some studies, that the overall cost of care may go up. That's not been seen in all studies. I'm not aware of really well-done studies in oncology-- they may be out there, I'm just not aware of them-- looking at the sort of overall picture, which, I think, is what we worry about.
And we also worry about the other part-- is that what we can't really measure is what happens to the vulnerable patient who goes to a practice that just isn't as well resourced, and we just can't get or the practice just can't get something through that's really medically indicated, and the patient has a adverse oncology outcome as a result.
And that's not really something that we, at least to date, have been able to really appropriately measure in terms of what potential impacts might be of not only prior authorizations but all the sort of different types of barriers that are present to affect care of vulnerable populations.
To some extent, you have to conclude that it must be saving at least the insurance companies some money since it seems like they're doing it more and more. And that almost has to be driven by a certain percentage of claims that are people just sort of drop it because they don't want to go through all of the time that it takes to do that. That certainly doesn't seem like a very good system for patient care.
I know, certainly, when I'm called to do a peer-to-peer, I always have a moment where I sort of put my head in my hands and wonder how badly I really want to do this. But obviously, if it matters, you have to push it through. And as you pointed out, when you finally get to the peer-to-peer, almost always they approve reasonable requests based on the exact same information they had when you submitted it the first time. It's not like you had to give some special, secret information to the reviewer to get it approved.
That's exactly right. And I think the arbitrariness of the program or the process is part of what oncologists are responding to, those sort of lack of transparency, the sense that one could easily talk to a computer and just punch in the key for the response and get the same results. I mean, I think there is this anecdotal sense of that. And how much of that is true it's hard to know without a definitive study. But I think that is a sense that people have out in the front lines, and that's part of the frustration.
Yeah. Well, so you state unequivocally that the system is broken. And I'm going to go out on a limb and say that I think you may be on to something. So what can we do? Or what are some possible solutions to this?
So, I mean, I think we can all agree that a shared goal is to deliver timely, high-quality care to patients with cancer. And I really emphasize both the timely part and the high-quality part because they really go hand in hand. And so whatever we do to try to constrain costs, we really want to make sure that we're not affecting the timeliness and the quality of the care that we provide to patients with cancer.
We make a number of recommendations in our editorial. But I think one key point is that we believe there is a role for some cost-containment strategies from payers. I mean, we recognize the need for it. But we think that payer-based coverage guidelines, prior authorizations, whatever sort of mechanism is there really should be the exception rather than the rule. And when they are in place, they should reflect the best and most up-to-date evidence. We shouldn't be arguing for something that was approved three years ago.
And I don't know that it's really the goal or the role of insurers to micromanage every aspect of a patient's cancer care. And so I think some possibilities, like insurers have these really large [? beta ?] databases, so trying to understand and focus on which expensive medications are frequently not used according to guidelines, having two-way conversations with oncology and patient advocacy organizations in areas of controversy to try to come up to some consensus of where these somewhat more soft indications might be covered, demonstration projects to look at alternatives to prior authorizations.
And I think all of these would be welcomed by the oncology community. I don't think the oncology community is unaware or doesn't care about this big elephant in the room, which is the high cost, right? But I think the pushback is really just the implementation in a way that just doesn't feel like it-- it feels like it's actually getting us away from timely, high-quality care. I think that's where the dissatisfaction comes from.
And when prior authorizations, or pathways, or whatever cost-containment tool was implemented, I think listening to the oncology community is really important. So are there processes that can be simplified so that you can achieve similar results with less pain? Are there ways to make the processes or forms more uniform?
So between the myriad of insurers that every provider deals with on a daily basis, every form is different. Every check box is different. Everything is different. It's a pathway. If there are pathways, you don't want to be navigating 20 different pathways, and the person on one insurance gets one chemotherapy in the third line. Maybe another on the other insurance gets this. I mean, it's just this is-- you don't want that to be how we practice medicine.
And when PAs are denied, I think we want to have a streamlined appeal process. I mean, we want to ensure that the person on the other end is qualified as a peer reviewer-- which, I think, there is a sense that that's not always the case-- and also empowered to use their clinical judgment.
So even when there is a clearly qualified peer reviewer, sometimes they just don't have the latitude to make clinical judgments. They're constrained in internal ways. And so I think that also gives the sense that the patient isn't the priority. And I think we just can't forget, right, the patient is the priority.
Yeah, I mean, I think giving everyone the benefit of the doubt here, I think everyone's goal is to deliver the best value care, the best quality of care to the patients, and to try to keep in mind the incredible problem of the rising costs of care. And the insurance companies have been placed in a difficult position where they really have had to take something into their own hands, which means we need to get everyone to the table to try to solve this. All right, well, thanks so much for joining us.
Thank you for inviting me.
And I also want to thank all of you out there who joined us for the podcast. The full text of the paper is available at ascopubs.org/journal/jop, published online in August 2018. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Jim Cleary talks with Dr. Pennell about this new resource-stratified guideline, which provides guidance to clinicians and policymakers on implementing palliative care in resource-constrained settings.

Welcome back, everyone, to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Now over the last decade or so, there has been a major change in our approach to the care of advanced cancer patients with the recognition of the importance of palliative care. There have been a number of trials now showing that integrating palliative care into cancer patients' care can make a major impact on their quality of life and possibly even their survival. And as a result, the involvement of palliative medicine has become part of treatment guidelines.
However, much like cutting edge biomarker testing or expensive drugs, specialist-driven palliative care also takes a fair amount of resources that are not available everywhere. So joining me today to talk about this is Dr. Jim Cleary, who just moved from the University of Wisconsin Carbone Cancer Center, where he started the palliative care program in 1996 and for the last seven years, has led the Pain and Policy Studies Group, a WHO collaborating center for pain policy and palliative care.
He's now been recruited to the Indiana University School of Medicine in Indianapolis, where he'll be the professor of medicine and Walther's senior chair in support of oncology and director of the supportive oncology program at the IU Simon Cancer Center. He's going to focus on building a program focusing on global supportive care and palliative care, which makes him the perfect person today for us to talk to about the recommendations of an expert panel that's going to be published this month in the JOP titled, Palliative Care in the Global Setting ASCO Resource-Stratified Practice Guideline Summary.
Jim, thanks so much for joining us.
Why, thank you very much for having me-- a real honor.
So can you start out a little bit by telling us about the progression of the role of palliative care in oncology, and what has led to the impetus for forming the panel that you were a part of?
So if we look back historically to the introduction of palliative care throughout medicine, it's actually been primarily in cancer care. If we go back to the original WHO guidelines in the 80s, it was all focused on cancer patients. And it's interesting if one looks at the very definition of palliative care from the word go, they said all the principles of palliative care can be applied upstream, earlier in the course of patients' illnesses from the-- even from the 80s.
But as we look at it historically, and particularly in the US, with the introduction of the Hospice Benefit, palliative care really became brink of death care. So that you didn't get hospice or pallative care involved until someone was actively dying. So we were missing out on that very principle of-- let's address all the issues, the skills that palliative care provides early on. Let's address these earlier on in the course of people's illness, particularly when it comes to people with advanced disease.
And it doesn't just have to be advanced disease to be including the skill set. So people who are getting chemotherapy, some may support it or call it supportive oncology, but really, it's the same principle-- supportive oncology, palliative care. It's total person care of patients with cancer and dealing with cancer.
So as we look at those, the studies have been coming out saying it improves quality of life. You mentioned the survival benefit that's been suggested or hypothesized. And while that may be there, for me, that's not the primary reason for doing this. It's the right thing to be doing-- to be addressing quality of life. And even trying to get us to move beyond what seems to be that magic mark of survival-- length of survival or time of survival may not be the only important thing.
Quality of life is becoming increasingly important as we address many of these issues. ASCO has recognized this, and in 2016, they actually published a paper-- again, a guideline-- the integration of palliative care into standard oncology care. And that was released in 2016, and it was based on what we would call research that was done in maximal resource institutions, largely in the high income countries. The United States, Canada, Western Europe, Australia-- those sorts of countries.
What the situation is in the world is that probably 80% of the cancers are now being diagnosed in low and middle income countries. And in those countries, most people are actually being diagnosed with advanced disease. And this comes from the paucity of person power in terms of diagnosis, the lack of surgeons, the remoteness that these people-- where they live. They're really presenting in different ways.
So as ASCO looked at this, and they've done this as well with cervical cancer, they said, let's get a guideline that is resource-stratified. So let's look at the issues that low and middle income countries face in getting this integration of palliative care and supportive oncology across the board. And that's what we aim to do in this setting.
No, that sounds like a very important intervention. I have a soft spot in my heart for this topic. Because when I was a fellow at Mass General Hospital, that was when Jennifer Temel was running her initial trial of head of care that led to this possible survival benefit, which was just suggested retrospectively, or at least post hoc, in that analysis, but I remember when this was greeted with a lot of skepticism-- that palliative care was that important in cancer care. And of course, now people broadly accept how important it is. So I'm great to see that this is going to be extended outside of just academic centers in the United States.
So one of the questions I have for you before we kind of delve into your paper, and this is a conversation I've had with Dr. Temel, as well. Most of the data is not just in maximized resource centers and countries, but also seems to focus on specialists trained in palliative medicine. Do we understand the aspects of palliative medicine, and what leads to quality of life benefits, enough to be able to extract those different pieces out and then extend them out beyond palliative care trained physicians?
I don't think we do yet. And we need to do more research on this. And I know that Jennifer currently has a query study that is looking at the role of telemedicine. At about the same time that Jennifer was doing the study in Boston, we actually did a similar study out of the University of Wisconsin, which looked at an internet intervention through CHESS-- Comprehensive Health Enhancement Support System-- and the service was integrating palliative care information, internet support for both patient and caregiver. And we actually found a survival benefit that mirrored this-- the Temel effect-- for people who use the internet system. So I don't think we have a very good start understanding at all.
I think Charles von Gunten has equally identified that there is this difference between primary, secondary, and tertiary palliative care. And primary palliative care is what all clinicians should be able to do. In Charles' papers that he's written on this, he's talked about oncologists should have a secondary level of palliative care knowledge and experience and be able to do this. And then really you need the tertiary level, or the specialty team, involved in palliative care for the difficult cases.
I'm not convinced, still to this day, that I need to see every cancer patient with advanced disease. What we need to do in palliative care teams is actually fill in the holes when the current treating oncology team is not able to provide them. And if you have an oncologist who is excellently trained in symptom management, communication-- together with good nurses and social workers, pastoral care, spiritual care, who can come in and help with this-- the role of the palliative care physician may actually go on the palliative care team. Maybe a little moot in most settings, but really, it's filling in the holes and coming in and making sure that patients are getting the appropriate level of care.
That appropriate level of care really does become tough in resource poor-- resource challenged settings. And that's probably true even in the United States, as well as in low and middle income countries. If the only health care center within 100 miles is actually with a primary health worker with minimal training, how do you get appropriate oncology care, let alone an appropriate palliative care integrated into that?
And I think one of the challenges that some of our panelists from low and middle income countries had was, well, how do you actually define good cancer care in our country? And that continues to be a country many people-- and I'll come back to remind listeners that hepatocellular cancer is actually one of the most common cancers in the world. And many of these people who have, and end up dying of, hepatocellular cancer never actually see an oncologist.
Now I agree that that makes sense in so many places-- just even in our own country here, patients struggle to reach specialist oncology care. And so I think the idea of Jennifer's, of trying to be able to do palliative medicine consults with telemedicine, is certainly an interesting potential solution for that.
So let's just dig into the panel's recommendations here, shall we? The guidelines are divided into different sections. And each section is very nicely broken down into what you term as basic, limited, enhanced, and maximal sections, depending on the available resources. So maybe we could go through them one at a time, and you can talk a little bit about them. So I think the first section is called, "Palliative Care Models." Can you talk a little bit about that?
So what we were doing with the palliative care model with the [? gain, ?] if you think about some of these basic, limited, enhanced, and maximal, we were saying, hey, basic is the primary health care center which I mentioned. It may be a community health worker, or a clinical officer as they are commonly called. It may not be a physician. There may be a nurse, but they may not even be a nurse in some of those settings. So the recommendation is that we should be training and addressing these people to actually even start thinking about palliative care needs in this setting.
So it's saying throughout the whole system, we need to be building in palliative care needs. Particularly in advanced cancer, one of the issues that comes up significantly, and is under Item 7, is ensuring that we have access to opioids for pain relief. And this becomes very difficult if you're talking about a rural community-- no one with a physician license or a nurse license. How do we actually get appropriate pain relief to these people, who may never see an oncologist, as they're dealing with advanced cancer needs?
So we've gone through and actually looking at the strength of evidence saying, yes, this has to be integrated throughout the whole health care system. And there are evidence from different models as we look at places like Kenya and Malawi as they've introduced palliative care throughout these settings. It's quite possible. Uganda actually has nurses out in many of the districts in Uganda, who are now licensed because of their special training, to actually dispense morphine. And that's a real change.
We go to other countries, which have a shortage of physicians interested in palliative care and doing this, and there are physician groups who actually say, there's no way nurses are ever going to be able to do that. Professional protectivism, if you want to look at it-- boundary protecting. No right answers, but I think these need to be considered. And we need to think outside the box with the models of care that we're providing to ensure the appropriate people are getting them.
I visited a hospital in Zambia-- the Children's Hospital in Lusaka-- where each child with leukemia had a small bottle of morphine on the top of their locker, which the parents were administering to the children for appropriate pain relief because of their leukemia. Really quite incredible to watch this going on in a resource poor setting, and this was entrusted to the parents to do with appropriate education. Because they're the ones who are most concerned and available to do this sort of work.
I've actually been to hospitals in other parts of Africa where the drug cupboard has actually been empty and the lock broken, and it takes 15 to 20 minutes to go to central pharmacy to actually get some morphine. So when someone is complaining of pain, that's not a good situation. So we need to make sure that all of these things actually fall into place and develop good care models. And that's really what recommendation number one does.
Recommendation number two goes to look and talks about timing. And this comes up as a critical-- when should you get palliative care needs addressed? And as I said with the primary, secondary, and tertiary, really, they should be addressed from the point of diagnosis, if not even before diagnosis if you suspect someone has advanced disease. And so you're really saying, hey, let's consider this from the word go with everyone in the course of the illness-- a palliative care team, not just the needs of the patient. But a team, in the basic and limited settings, should probably get involved with overwhelming symptoms, particularly metastatic disease.
And if a decision not to go for life prolonging therapy is made, that's when I think we need to be engaging teams at that stage. And really, it's coming in with the maximal. And if you've got the appropriate resources, it's saying everyone. And this comes from the 2016 guidelines as well. We should have this integration early in the diagnosis and ideally within eight weeks of diagnosis. The palliative care team should actually be involved at that stage.
Oh, that makes perfect sense. I certainly remember when this idea of early palliative care started coming out. And it's so much easier for the patients when they are plugged in and connected with the palliative medicine team earlier in their disease, rather than trying to call them in late. And it's much more jarring and disturbing to them, and they don't get nearly as much of the benefit of the care, I think, at that point.
And often pain control is a way I get involved early on. Other symptom management-- how can we help you through chemotherapy? Some of the issues go on. It does actually open up opportunities. Yes, I can maybe spend some more time there than the oncologist. Many nurse practitioners-- advanced practice nurses-- are actually doing this on their own. But it's coming in and helping the oncologist. It's building up that team. And as the disease transitions, that jarring nature of all this-- this guy who's now coming to meet you because I've run out of options. No, you're part of the team from the word go and will continue to stay involved.
Yeah, absolutely. I think that has been my experience, that that makes the best sense. So the third section of the guideline addresses the workforce knowledge and skills. And how does that vary from the various resource levels.
So this comes up, the resource levels and if you even go back to the WHO definitions of palliative care, we use the term interdisciplinary. It's very hard to be interdisciplinary when you're a single person. Although I often joke that Dame Cecily Saunders, who started the modern hospice movement, was trained as a nurse, a social worker, and a physician. So she could have a multidisciplinary team all by herself.
So it's the basic level. If you're a single clinical officer, that may be very difficult. A single nurse-- that interdisciplinary team is really something that may be hard to come by. But having those basic skills is something that we need to teach.
But as we move up into the limited or district level facilities, working on building teams together, and teams in some cultures-- and particularly with the nurse-physician relationship not being as strong as I think we see in most places in the United States, Europe, and Australia and New Zealand-- often these are real issues of hierarchy between the physicians and nurses. But we need to be ensuring that they do function as a team to maintain and provide the best level of care.
So that's one of the things that we're looking at, recognizing that we are a team that does this. And that team continues to grow, particularly, we hope, with regional facilities or the enhanced level with the introduction of a counselor into that level. Again, if you look at the resource poor areas when you start talking counselors, one statistic I've heard is that there are three psychiatrists for the Horn of Africa, which is Ethiopia, Somalia, and those areas. And you think of only three. So the ability to train-- or having trained counselors around-- is something that is not common.
So it's really integrating across the board, particularly as we move up to higher levels-- regional facilities and then to maximal, national cancer centers-- making sure that we have appropriately trained social workers and counselors available to join this team.
So addressing all of the members of the team-- you know, the nursing roles, the spiritual care, the counseling-- and then just the recognition that in some places it may end up being the caregiver, or the physician, or whoever they are dealing with, that has to assume many of these roles, I think, is a nice recognition. Ideally, you'd love to have a large interdisciplinary team. But it's having the available resource, rather than who does it, that is important.
Exactly right, and in many cases, it may actually be the nurse who is doing most of this work. And we even find that in our own situations here, it's often the nurses giving chemotherapy who may be doing a lot of the counseling with patients while they're administering the chemotherapy. I even make the comment to our own folks in in-patients, it may actually be the person who's working on housekeeping who is actually doing a lot of interaction and hearing of the needs of the patient, just because they feel comfortable talking to them, whereas they don't share that with others. So we don't exclude any member of this team across the board.
That's really interesting. I don't know if you read Bloom County, the comic strip, but there is a storyline over the last couple of years of a sick child in the hospital. And it's the maintenance man who ends up providing most of the support to the child in this family and it's a really touching storyline. It reminds me of that a little bit.
So I hope that's not because we weren't providing it, which is often something that can happen. But I think it reflects some of the comfort that people do have in dealing with like people. White coat syndrome, I think, applies as much to adults as it does to children. We need to look at those issues, that talking to that man-- that person in the white coat who stands at the end of the bed with 15 other people. That's not really a situation where you can share your inner thoughts and feelings.
No, I think that's true. And then you touched on this a little bit earlier, but the seventh and certainly a very critical component of this, is the availability of opioids to help deal with pain. I guess it hadn't really occurred to me that this was a major problem, because drugs like morphine should be relatively inexpensive. But this is I'm guessing a major issue throughout the world.
So 80% of the world's population lack access to appropriate pain control. And it's even made worse by the current dilemmas that we're facing, the unbalanced situation that we have in the United States with the current heroin and fentanyl crises. And I say that, because I think we've moved somewhat beyond most of the deaths being caused by prescription opioids. There's increasing evidence that people in the United States are getting first access through heroin and illicit fentanyl.
So that these people are lacking access to the basic essential pain medicines, both postoperatively and as they deal with advanced cancer. And so we're even seeing some of that now reported in the United States, that people are actually being denied access to opioids, because of shortages in this country, as they deal with cancer.
So it's a critical issue. We need to make sure these are all available. We saw even back in the 90s-- we saw some pharmaceutical companies in China saying, you guys don't need an immediate release morphine. Just use sustained release morphine. The reality is that immediate release morphine, even a morphine solution, together with injectable morphine, is something that should be available at the most basic settings for pain control of cancer patients. And then we can move up oral morphine together with sustained release, if you need to, in different forms.
The costs can change. We see some countries in the world with fentanyl patches as the primary medicine used. But the cost of these is dramatically much greater than, in fact, it is for immediate release morphine. People say that levels are steadier, it's better pain control, and things with fentanyl patches, but the evidence doesn't necessarily support that overall.
And so we will come back to the gold standard being very much based on oral morphine and making sure that's available in different formulations. And I will stress while this guideline was for adults, one of the advantages of a morphine solution does allow you to titrate and dilute the morphine appropriately for children across the board. You can't do that necessarily with tablets.
So I think there are absolutely access to medicines-- and not just the opioids, but particularly the opioids-- is something that's being addressed with a number of levels and making sure that the current situation in the United States doesn't come back and not only rebound here for cancer patients, but really impact cancer patients around the world.
Yeah, that's certainly a major topic in the United States, and I'm sure that's true elsewhere, as well. Well, so that brings me to my next question, which is-- while these recommendations make wonderful sense, and in many ways it's kind of reassuring. Because in some places when I talk about palliative care, and they say, well, you know, we don't really have access to specialist palliative care, a lot of this can be done just about anywhere as long as there are recognized the aspects of palliative medicine that are available and necessary.
So what are the next steps to this? So the guideline is going to be published. How is ASCO going to work to try to make some of this more available?
So I think it reflects the impact of ASCO around the world. ASCO is-- while it's the American Society of Clinical Oncology, it actually has very, very real impact. We're starting to see research take place. So the African Palliative Care Association is already beginning to use a palliative care outcomes scale, together with King's College in London to bring about this. So it's actually-- we're seeing a push.
I think we're going to see some of the QOPI measures come out and be part of this international work. So for instance, as you mentioned, getting chemotherapy in the last two weeks of life is a negative QOPI indices. Getting people into hospice, we're seeing as a positive as we move forward.
So I think that we're going to see this overall from ASCO coming out and saying, this is absolutely critical. ASCO is a player on the international scene. Works with a number of international organizations-- the NCI, Global Health Institute, the NCCN, and others are looking at the-- the Breast Health, Global Initiative. So this is all moving forward together with the World Health Organization, the Union for International Cancer Control, UICC.
Many people are targeting this, and I think it's actually going to be the overall recognition of the importance of this. Many people have followed for years, saying we will do what ASCO does. ASCO is now saying, this is important. And I think we're going to see this change in low and middle income countries because of ASCO's leadership, and that's going to be critical.
Well, I certainly hope that's the case. Because this really does sound like an incredibly important initiative. So Jim, do you have any take home points you'd like to give to our listeners as we wrap up the podcast?
So take home points are to realize, within your own practice, that palliative care is important to integrate. But I think at this stage, it's an awareness of the importance of palliative care in cancer care around the world. We don't often think of that outside of our own settings. But it's absolutely important.
Become involved in advocacy as you move forward. And promote this, both regionally within the United States, and for those listeners who are listening outside of the United States, work with your oncology organizations to say, what are we doing with palliative care and cancer care across the board? And I think it's those sorts of things where we're actually going to be seeing those changes as we move forward.
Well, Jim, thank you so much for joining me today on this podcast. I'm sure our listeners are really going to appreciate this.
Thank you very much, Nate.
And I also want to thank the listeners who joined us for the podcast. The full text of the paper is available at ASCOpubs.org/journal/JOP published online in July of 2018. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Blase Polite discusses the latest State of Cancer Care in America report, and the opportunities and challenges confronting the cancer care community.

Read the related article "The State of Oncology Practice in America, 2018: Results of the ASCO Practice Census Survey" on JOP

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-us.com.

Welcome back everyone to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JOP. It's that time of year again, when ASCO releases their annual report titled The State of Cancer Care in America, which has a goal of increasing awareness among policymakers and the larger cancer community about opportunities and challenges in the delivery of cancer care for the United States. The 2017 version is being released this month, and is always one of the most popular manuscripts and, to be honest, one of the most popular podcasts we do here at the JOP.

Joining me today is Dr. Blase Polite, associate professor of medicine and deputy section chief for clinical operations, as well as the executive medical director for cancer accountable care at the University of Chicago. Dr. Polite is a past chair of both the ASCO cost of cancer task force and the government relations committee, as well as being a fellow of ASCO. Today we'll be discussing the State of Oncology Practice in America, 2017, Results of the American Society of Clinical Oncology Practice Census Survey. Dr. Polite, thanks for joining me.

Nathan, good morning. It's great to be on with you again.

So why don't we start out just by talking a little bit about the background and the purpose of this annual State of Cancer Care in America report. How does ASCO get this data, and really what's the intended purpose?

So we're very excited this year. There's actually been a change to the way we do things. So in addition to the standard survey that we send out the practices, we've also been able through the work of our excellent team at ASCO to use something called the physician compare website and database from the Center for Medicare and Medicaid Services, CMS, that allows us for the first time to really get a sense of the true number of oncologists practicing across the United States, where they're located, how big their practices are, et cetera. So now we have two sets of data, one that gives us a nice sense of the geography of the total census of care of practices, and then our more detailed in-depth look of our survey practices.

And you know, this is really one of the most important things for those of us who work at the ASCO level, because this gives us a true pulse of what's going on out there, what are the market trends, and really, most importantly, what is it that is bothering practices on a day to day basis that we at ASCO then can try to figure out from a policy standpoint, can we work to make things better?

So one of the things that the State of Cancer Care in America always does is look at sort of the demographics and the makeup of the different practices. And have there been any significant changes this year? And is this something that is part of a trend, or anything that surprised you?

Well, the one thing that we continue to see, and we've gone back to 2013 and we've looked at the numbers of the-- using the physician compare, where we really get a sense of all of the oncology practices out there, is we're starting to see more and more consolidation. And specifically what I mean by that is we continue to see more oncologists every year, but a fewer number of total practices. So again, we're beginning to see more practices consolidate into larger groups. Not surprising, given the economic pressures and everything else that we see. But that that's probably a more consistent trend that we're seeing over the years.

Well, that certainly makes sense, I think, with the payer issues. And that kind of brings us to our next part here. One of the main purposes of this is for oncology practices to be able to list their top sources of pressure and concerns. So can you talk a little bit about what the concerns of the oncology practices were for 2017?

Yeah. So we were able to look at concerns within the census, both at an overall level, and then we're able to look at it specifically by how we break up the practices, which are academic, hospital, or health system owned, and physician owned. And what shop really to the top this year and wasn't really even a contest, was payer pressures. So this is the one thing that people are screaming from the rooftops, 70% of practices were physician owned, and really over half of other practices are saying that payer pressures are the biggest thing.

And then when we do payer pressures, we ask practices specifically what do they mean by payer pressures. And again here you look at the three things. They all kind of follow the same thing. The number one is prior authorization. Number two is coverage denials and having to do appeals, and number three is these peer to peer requests from medical directors. So these are the things that are bothering every single practice out there, and is really rising to the top.

In fact, we also then ask, well tell us about the resources you put forward in order to deal with the prior authorization. And we find on average practices have six full time equivalents dedicated just to doing prior authorizations. And we have one practice that has over 100 people dedicated to doing that. I know at the University of Chicago we have a dedicated group of about 30 to 35 whose only job is to deal with prior authorizations. So this is one of those things that I think we all feel. It frustrates everybody, and it's clearly something that will become a major focus for ASCO to figure out how can we find a better system.

I know that certainly resonates with me, and I'm sure all of our listeners. This is not going to be a surprise to them. We also have a, I'm sure, a fairly large group that does this at the Cleveland Clinic, but even the prior auths and peer to peer requests that make it through that layer are incredibly disruptive. I find it hard to imagine how individual practices that can't afford to hire people are dealing with this. And I guess that probably feeds into this consolidation that you are seeing.

Yeah, absolutely. I mean, I think that's a major part of it. And so one of the things I want to highlight is we are beginning this year with trying to turn the State of Cancer Care in America into a living sort of document, and what I mean by that is instead of just the once a year publication, within the Journal of Oncology Practice we are now going to have a state of oncology care series, and that will be both invited commentaries specifically addressing the things that our members are telling us are a problem, as well as looking for original research that we think answers and helps provide actual data to support some of the things that concern us.

And so it won't be a surprise to anybody that one of the first things coming out of the gate is going to be the issue of prior authorization. And what we've done there is we've invited Mike Colosia, who used to run the oncology business Aetna, and Lee Newcomer, who was recently retired from United Health, both very good friends of ASCO, both very, very thoughtful, as well as we're going to have a commentary on the physician side to really go at this question of why do they do it? What are some of the alternatives to it?

Because I think what you find when you get into these discussions is nobody likes prior authorizations. Insurance companies do it because they feel that there are times where we are doing things that are not supported by the evidence, and it clearly has some money saving to them. But if you really push them, they don't like the fact that they have to hire a lot of people to do this, and they would like a better system as well.

Yeah, definitely kudos at ASCO for making an effort to trying to do something about this and not just report on it. This is clearly over the last several years becoming more and more of an issue. Everyone complains about it, but it's hard to know on an individual basis what you can do about it. So I'm looking forward to those papers.

So in past years, one of the major perhaps, you know, in some years, I know even the top concern was dealing with the electronic health record. And it seems like it's fallen down a little bit this year on the list. I don't know if that's because we're actually making progress with interoperability and people are becoming more comfortable with that, or if it's just that other issues are becoming more pressing.

Yeah, I'm sure it's a little bit of both. But there's no question that when we look back from 2015 to now 2017, each year we've seen an improvement. Back in 2015 electronic health records were about 45% of people listed that as their top concern. You know, this year that number looks more like 35%, 30%. And when we dig a little bit deeper into the electronic health record issue, and what we find is probably the satisfaction that people are getting is from the interoperability.

And specifically I think it's interoperability within a EHR system. Meaning, you know, for example, University of Chicago, we're on the Epic system, and in the last year I have finally been able to actually view records, notes, radiology reports, pathology reports, from any other center that is within the Epic system. I still can't view records from another system, which again, I think remains a source of frustration to everybody.

But just that improvement has been the one that I think it's been helpful to everybody, and it just saves so much time, especially these days as the original pathology report was amended 14 times as we get all of our next generation sequencing, et cetera, so the records that you get don't tend to have all that, just to be able to go and sort of pull that information has been helpful.

I think the other thing is there's a learning curve. And I think, as we've interacted with the electronic health record more, people have learned the tricks and some of the shortcuts and some of the ways to move it beyond just being an electronic version of the paper chart. Now interestingly, when you take a look within our different sort of systems, who rates electronic health records as a problem, the community practices actually are the most satisfied, and the academic doctors are the least satisfied.

That sort of rings very true to me, and I think part of that is more the learning curve issues. I think the community physicians who are in clinic on a more regular basis have really learned to start making electronic record their friend, but I think the academics who don't spend as much time in clinic have not taken the time, I think, to really learn how to optimize their use, and so remain a little bit frustrated by all the clicks and other things that are required, and I think some of them, if you took them in a dark room, would say, gee I would love to go back to paper records where I could just scribble things on the back of a sheet of paper and I'd be done.

But no, I think we're making improvement here. But again, this is another area that ASCO has been very, very conscious of, have been working very hard with the electronic health record vendors, so again, you will see a set of articles coming out in JOP looking from the vendor perspective, so we can get their sense of what they think they're doing well and what they're not doing well, and then from some of our experts, clinicians who really know the health informatics side of the world, people like Deb Pratt and Linda Wasserman, who really have delved into these issues and kind of given the perspective from the clinical side.

I'll say the other group that is very frustrated about what's going on with EHRs and there continues to be a lot of activity, is Congress. So as you know, ASCO, we spent a lot of time with the congressional committees, and they realize that in some ways they helped create this mess of lack of interoperability. You know, in 2008 with the Affordable Care Act, a lot of money was put in by Congress, taxpayer money, to really get practices on electronic records. But I think what they will admit is they wish they put more strings to that, and more requirements that they work together, you know, et cetera. And they didn't. And they're angry by a little bit of the foot dragging.

And so I think everybody would like us to get to a system, you know, as I say, very similar to what all of us experienced who have traveled around the world, that I have an ATM card and I can be in the middle of a rural village in China and put my card into an ATM machine, and somehow or another it finds my bank and gives me local currency. But the fact that I can't see the electronic health record of a facility across the street from me when I'm at the university just doesn't make sense and doesn't ring true to us that there are major barriers to that.

So we suspect it's more competitive pressure, and that it's going to require federal and congressional mandate to say we gave you taxpayer dollars to build this infrastructure, you certainly are making a good living off of it, now you have some responsibility to help the ecosystem out. So again, we will continue to push that pretty hard at our level.

I certainly recognize this frustration in my own practice, and I have the same experience using Epic that the Care Everywhere function, when I work with places that have a similar one, you can suddenly see the real potential of interoperability, and how really seamless it can be of transitioning care from place to place.

But then I see a second opinion of someone who goes to a hospital across the street and suddenly I've got a substandard paper record of a print out of 100 sheets that usually don't have the most recent updates of the pathology reports and the doctor's note, and you're suddenly back in the 20th century again. So I'm glad to hear that things are moving forward with that. I think we're experiencing-- the challenge of trying to fix something after the fact is always harder than it would have been to do it right the first time, but at least making efforts in that direction.

So we talked about EHR, we talked about payer pressures, are there any other significant sources of pressure that the practices were reporting that are worth discussing?

Yeah, I mean, I think the other one, and this is the one where we see much more for the private practices, so it's practice expense and drug prices. So we're beginning to see that rise more and more to the top. And again, goes back to our talk about consolidation, that as these drugs get very, very expensive, I think what all of our listeners hear, but maybe people who aren't involved in day to day don't understand is when you hear about these $100,000 price tags, et cetera, this also represents inventory that practices have to keep on hand, and have to manage, and as more and more payers are squeezing what they're paying for the drugs and the margin on drugs, it's becoming more and more of a liability for practices. So I think that is clearly something that the private practices are telling us.

The academic practices, the staffing issues, and I believe that the two are actually probably the same issue. Academics who don't see the books, and a lot of them don't have to deal with that don't realize the expense pressures, but where it's plain in is in hiring nurses and advanced practice providers, the dollars are squeezed. And we're all getting pressure because the dollars are squeezed, and so every hire has to be justified. So, you know, I think the academics are seeing it that way.

And then one final question that was on the survey, was they asked practices if they were ready for the Medicare merit based incentive payment program, or MIPS program. And about 58% of practices reported being ready, and a certain percentage said that they were at least partially ready. Do you think that sounds like good progress at this point?

This is one of those numbers that's in the eye of the beholder. I actually looked at those numbers and was quite impressed, and specifically, again, when we break that number down by practice type, what I'm most happy about is that our private practices, about 75%, 74%, 75%, reported being ready prepared for MIPS.

That actually was a group that I was probably the most worried about, given the complexities of trying to understand this. And again, I give strong kudos out to ASCO, as well as others who have been focusing on MACRA and MIPS like a laser beam from the second that the legislation was just a twinkle in the eye of the congressional committees, to its passage, to the writing of regulations, and we have spent pretty much every year at ASCO, and the best of ASCOs of doing town halls, going through these issues. Many of us have been going around the country to state societies and really emphasizing, and strong kudos go out to Steve Grubbs and the entire clinical practice affairs division at ASCO, who have put together some really wonderful tools to help practices extract things from the electronic record in order to be able to do MIPS.

So I'm actually very encouraged by what I see on the private side. On the academic side and the hospital owned side, I suspect that the number is actually underreported slightly, because again, if you're part of a large, multi-specialty group, you're not able under MACRA and MIPS to sort of single the oncology group out.

And so what tends to happen is most of this gets taken care of at a much higher or more distant level from you, and it's likely that the quality metrics that are reported have nothing to do with cancer. They're reporting on blood pressure control and immunization and hemoglobin A1C. So I think a lot of academics and hospital owned physician groups probably don't see the work that's being done, because it's being done for them. But the groups that have to do it because there is no plan B, the private groups, I think are doing a good job.

Certainly ASCO has done a great job of trying to educate everyone about this, and continues to do so. So if you're encouraged, I'm encouraged. So can you just give us maybe some take home points for 2017 State of Cancer Care for America, what you'd like our listeners to take home from this report?

In terms of take home, again, I think what we're hearing very loudly are the payer pressures and the issues that remain with the electronic health record. And so we hear that loud and clear. And those are issues that we're going to continue to work on. Again, I really want to encourage all of our listeners here to stay alert for anything that is branded as part of the State of Oncology Care in America, they're called SOCA. We will be branding those things within the JOP, so both, again, invited commentaries from thought leaders to help us.

And again, the way we're inviting them is really focused on I don't want a high level academic discussion, I want to hear about how you view the problem and what you see the solutions are. And again, we're going to get it from a diverse set of voices. So it's not just us complaining. I want you to hear from the payers. I want you to hear from the electronic health record companies, how they view the situation.

So I'm very excited about this series. And again, as we get original research in, we are constantly looking for original research that meets this sort of brand. And the way we've defined it from an editorial perspective is if I get an article in, and I think it addresses something that someone in a practice is thinking about on a weekly basis, whether it be the practice administrator or the position lead, or those of us who are out in the trenches, that's an article that we're going to brand as SOCA, that this is one you might want to pay attention to not just for academic interest, but this actually may help you think through what you're dealing on a daily basis. So I'm very, very excited by that.

And again, I think the other thing with this series is that people will find interesting is the use of a physician compare, so you really get a sense of what the oncology force looks like. And let me just kind of give people some of those statistics. So when we look overall, they're a little bit over 12,000 hematologist or hematology oncologists or plain out straight oncologists that are practicing in the United States. They basically put themselves into around 2,200, 2,300 practices around the country. So that's who we are as oncologists.

And one of the issues we didn't have a chance to touch on too much, but has concerned me from the very first time I got involved in this survey, is when you take a look at the mismatch between where the oncologists are and where the patients are, for example, about 7% of our oncologists, 9% of our practices are in zip codes that qualify as rural zip codes. But we know that about 20% of the population lives in rural areas.

So I continue to be concerned about the care for patients in rural areas, especially at consolidation and payer pressures mount. I think it's harder and harder for those small groups to be able to survive in these small areas, and I'm concerned about what that means for the patients and their access to really high quality oncology care. So that's another area that I think we really need to keep an eye on, and not forget. And so within the survey you'll see a really beautifully done map that shows where the practices are, where the survey practices are, and then you can see there are clearly parts of the country that there are blanks.

Yeah, no, that's definitely a major area of concern. As things get constricted by costs, we may need to think of other incentives to try to incentivize practices to continue opening offices close enough for patients to reach. Anything else that we didn't talk about?

The survey actually just went out again, so for those who are listening, talk to your practice administrator. Make sure it didn't go into the junk mail. I think we even give Amazon gift cards out this year to the first few hundred to respond or something along those lines. But really, again, what I emphasize, and I emphasize within our own group, is that this information is critical. This is how we get a pulse on what's really going on out there, and not only is it important to ASCO, but we feed this data to the executive branch.

So for example, on the rural issue, HRSA, who's responsible for a lot of the health shortage areas in the country. We feed them this data so that they know what's going on in the cancer and oncology workforce. And so there are a lot of groups who actually rely on the census, and this is how we build policy, and this is how we sort of think about where our priorities should be.

So we really do listen. This is not just a survey that we can just put out on paper and then forget about it. This really is something that a lot of people pay attention to, so the more data we get back, the richer the data we get back, the more we have things that we can act upon. So please, when you see that survey, please respond to it.

Yeah, and I think it's actually fairly impressive that for really an uncompensated survey that a majority of practices, or at least a majority of the workforce, end up getting included in that. So that represents a lot of work and a lot of recognition of the importance of this. So Dr. Polite, thanks so much for joining me today to talk about this. I know this is always a popular podcast, and I'm sure this one will be no exception.

Well Nathan, again, thank you. And I really want to give a plug out to the work that you do. These podcast series are absolutely fantastic. I encourage everybody out there, you know, I'm probably-- I guess I'm preaching to the podcast choir, but tell your friends out there to subscribe to the JOP podcast, because I think unlike a lot of the other podcasts that tend to go with articles that I think are a little bit more sterile, you just do a wonderful job of making them conversational and getting, I think, to the issues and the questions that people who are reading these articles are asking.

And it's just such a wonderful supplement to, again, I think the rich content within JOP, but really to get the folks who are involved in writing the articles, to give you a little bit behind the scenes and give you a little bit more depth. So thank you for what you do. I know you also are busy and have other things to do, but you do a tremendous job with it. So please tell your friends to go ahead and subscribe to the JOP podcast.

Well thank you for the kind words. We'll pull that out and maybe put it in our marketing for the JOP podcast. And I also want to make sure to thank the listeners out there who joined us for the podcast. You can read the full text of the paper at ASCOpubs.org/journal/jop, published online June 2018, and please keep your eye out over the coming year for all of the SOCA original and invited manuscripts that are going to be coming out. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Nathan Pennell and author Dr. Thomas W. LeBlanc discuss how open notes have become a routine part of the patient experience, and why physicians might want to elicit and address concerns that arise from notes.

Read the related article "Open Oncology Notes: A Qualitative Study of Oncology Patients' Experiences Reading Their Cancer Care Notes" on JOP

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-us.com.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic and consultant editor for the JOP. Now many clinicians have probably noticed over the last few years that both in oncology and in medicine, there is a movement that patients should have better access to their electronic medical records, and that often includes clinicians' notes.

This is a concept known as open notes, and in the modern world we live in, where information is readily available 24 hours a day and seven days a week, it makes perfect sense for medicine to follow suit. However, little is known about the real risks or benefits to cancer patients of this open note movement. Is it a positive thing that builds patient empowerment and improves trust, or are their potential negatives such as risk of misunderstandings and privacy concerns?

Joining me today to discuss this topic on behalf of his co-authors is Dr. Tom LeBlanc, Associate Professor at the Duke Cancer Institute, to discuss his paper titled Open Oncology Notes: A Qualitative Study of Oncology Patients' Experiences Reading Their Cancer Care Notes, published online on the JOP in February, 2018. Tom, thanks so much for joining me today.

Thanks so much for having me.

So can you tell me a little bit about this whole open notes concept?

Sure. So as you probably have seen, most of the modern electronic records that many large health systems are using, and even smaller community practices, come with things like patient portals. And increasingly we're seeing that practices are starting to turn these on and to turn them on in more significant ways.

So the traditional way was that patients could have a kind of one-way exchange of information where they could just read things like their laboratory results, or maybe X-ray reports and things like that. Now we have two-way communication. They can send messages back and forth to their clinicians. And some places, like Duke, for example, and many other centers like it, have even allowed patients to read parts of their electronic records, in this case, their progress notes.

And as you mentioned, this is part of more of a movement towards patient-centered care where the idea is that by increasing transparency, we would hope that people might be more engaged in their care.

It sounds like this was a real need to do a study like that. So why don't you take me through your study? How did you do this?

So basically, we went into the Oncology Treatment Center and tried to find patients who had already used this system. And so we decided that we would focus first on patients who had advanced cancer because we felt like that was the area where maybe we were most concerned that a patient might read or see something that they didn't know that might really make them upset or create anxiety or worry. So we started with that particular population.

And as part of the screening, when we were looking for advanced cancer and folks getting active treatment in the Oncology Treatment Center, we also looked for people who had an active MyChart patient portal account. And then we went and screened amongst those folks for those who had actually already read a note.

So if you imagine, these are kind of the super users of the patient portal. There are a lot of people who have signed up for the patient portal who have never logged in, for example. We didn't talk with those folks. There are many people who use it regularly to review labs, but didn't even know that you could read notes. We didn't talk to those folks. We really only talked with people who had actually used and accessed the notes.

And then we conducted a semi-structured qualitative interview. So we basically had a guide with a series of questions to help us better understand certain things that we were really interested in. Like for example, we wanted to know overall what people's experience was like reading these notes, but we also wanted to know about what things they might change. So we kind of ended it with a request for some kind of feedback and suggestions about their experiences. And we did that for 20 patients in the cancer center.

So what did you find in these interviews?

And actually, one other thing I should mention about that too is as part of these interviews, also, we opened up the patient portal and then had them read through a note along with us as part of the interview, and had them kind of out loud about what it was like to do that and what they were sort of thinking and gleaning from what they were reading. It was kind of an interesting thing where we learned some surprising findings.

Yeah, I imagine so.

To talk a little bit more about what we actually found, when you do these kind of qualitative studies, although the number of patients interviewed, of course, is small-- like I said, this was just 20 patients-- you end up actually with a lot of data. We audio recorded and then transcribed these, and then a group of us read through these interviews and coded them for what types of things we thought were going on when patients said x, y, or z, and then in the end, collapsed all of these different kinds of codes into some general themes about what we thought was going on in these interviews.

And the general themes were fourfold, basically. First, we found that reading notes increased comprehension overall. Second, that there seemed to be this kind of reduction in uncertainty or anxiety, and actually this enhancement of feeling in control. Third, we also heard a lot about increased trust, like in the cancer care team or trust in the oncologist that was seeing and managing that patient. But then lastly, we did find just like in some of those primary care studies, that for at least a minority of patients, there did seem to be some increased anxiety associated with reading these notes.

I mean, in some aspects, you said that they actually had less anxiety, and some that they had more. Is there anything you were able to pick out that would indicate one or the other of these being at higher risk? Or was it completely dependent on the individual patient?

Yeah, it was really interesting. The sense that I got from listening to these interviews and conducting some of them is it really seemed like the patients who were more anxious were kind of a different breed than the people who felt more in control and empowered by reading the notes. So if you listen to the interviews from the more anxious patients, some of them actually described almost this compulsion. Like they would get this alert on their phone, this push notification that says you have a new note that you can read now in your portal.

And they would know that it was going to make them more anxious because they had had the experience before. And yet they did not feel like they could avoid looking at it. They just felt this compulsion to open it and to read the note. And they knew they were going to feel bad about it, and maybe be forced to confront some things that they didn't want to confront about [? notes apps, ?] but they did it anyway because it was made available to them.

And some of these people actually said, I wished that I could turn that off, or I wish I didn't know about it because I don't really want to look at these things. But now it's there and I know it's there, and I just can't help but look.

And if you contrast that with some of the other patients, we heard a lot of things about how they felt so comforted and relieved that their oncologist wasn't keeping information from them. And all things that they had told the oncologist about, that person had documented. Like in the interval history, there was the story about how they were feeling and what was going on. And they felt that that often did really mirror the content of the discussion and the focus of that visit. So they felt like this is a team. I trust my oncologist, and they're not hiding anything from me. And that was an empowering thing.

One of the surprising things for me, though, that it's a little bit more nuanced and maybe doesn't come out as much in the paper as it could-- this is probably something that needs to be more of a focus of future studies-- is I got the distinct sense that many of these patients actually got a bit of a false sense of security from reading the notes. Like oh, I read all of these notes, and I Googled all the words. And so that means that I know everything about what's actually going on.

But then the way that they talked about their disease, knowing what stage their cancer was and what kind of treatment they were getting as well, as the investigator, I could tell that many of these patients really probably didn't actually understand their prognosis very well. And they thought that they did because they had been reading all the notes and working really hard to understand all of this.

So one concern that I do have is that it's not clear that increased transparency about the documentation really does actually lead to better understanding. People feel like they're more in control, they feel more trust, they feel like they know what's going on. But I don't know if they actually really have increased comprehension in a meaningful sort of way. And this is something that I think needs to be studied further.

It's very interesting when you think about this because of course, if every patient could just see the note, and the doctor, really, was just making it the way they normally would make it without thinking about a patient reading it, then maybe, in some ways, that would be more useful because the physicians probably knew that the patients were going to be reading their notes. And I wonder if that influences the tone of what they write. Did you do any interviewing of the actual doctors who documented the notes?

No. And you are absolutely right. This is actually the next thing that we're doing. So the next phase of the study is that we're interviewing some of these physicians. And it won't necessarily be paired up that it's the same doctors who are seeing these patients. But we really just want to interview some docs who have had experiences with their patients reading notes and get a better sense for how they feel about it.

I've certainly heard things anecdotally about it, and some physicians have said to me that their notes generate a lot of additional phone calls or inbox communications where patients can send a note directly to them to say, hey, you know that thing you wrote in your notes? That's not correct. I have not had that experience myself, so I don't really know what we're going to find, but that's the next phase of this work.

I mean, I know that because my patients can access my notes, I'm very conscious about some of the things that I say, to not be too speculative, or perhaps be a little more pessimistic in thinking about which way I might be leaning about a suspicious finding, and we're going to repeat a scan in a few months. And I understand now that if someone reads that, they could become quite anxious. So I'll be very curious to see what your results are when you start interviewing the docs.

Well, me, too. And one of the things related to this that I'm really curious about is whether any of these folks are actually restricting access to notes. Now this is something that's possible in some electronic record systems like the one that we use. And you can actually just type a dot phrase in a note that basically blocks the note from being made available to the patient. And I've seen at least one instance of this happen, but I don't actually know why a person would specifically do that, and if it's something that they do across their whole practice, or maybe only certain scenarios or certain patients. So I'm really curious about that.

This relates, too, t one of the other things that we found from this study, which is when we asked patients what they would change about the notes, it was really fascinating, although maybe not that surprising, to hear what they said. So for example, many patients complained that the notes were just really difficult to read because they were so repetitive.

And they noticed pretty quickly, they picked up on these patterns of our typical SOAP note structure in medicine that you kind of skip over all the junk in the middle, and that stuff mostly doesn't change. And it's really just the very beginning and the very end of the note that I care about. And now I just open this thing up and I zoom right to the bottom, and I read that piece because that's what matters.

And so patients said it really would be more helpful if these certain terms were explained, like if I could click a link when I'm reading the note and it would explain a medical word for me, or if the doctors wrote things in less complicated of a way. And it really opens up this difficult issue, I think, for discussion and debate, which is what's the purpose of the note and who is it for?

So when patients are now able to read these notes, which historically were really just for physician-to-physician documentation, and then increasingly to support a level of billing or to serve as a record for future inquiries if there were ever problems or medical legal issues, now the notes actually serve another purpose around communicating with the patient. And if so, should we be doing something differently?

And nobody knows the answer yet. But I certainly think we all have lots of ideas and could speculate about, maybe, how we could spend our time better when we're doing our clinical documentation, and how we might reinvent notes if we could start from scratch and weren't told A, B, C, D, and E has to be there to support your level of billing.

No, I don't think anyone would invent the current structure again if they didn't have to support the billing. That seems to be the primary reason for half the stuff that we write. And then at the very end, there's just the one summary of a few lines that actually is the meat that you're looking for.

And I think that's absolutely right. If the patients are going to be accessing this routinely-- and maybe this should be something that we should actually give to the patients or ask them to read, as opposed to just allowing them to peek in if they're interested-- that probably should be designed in a format that's designed to be accessible to them so they understand it.

Yeah, I really agree. And now that technology has advanced so much, even in just the last five years, thinking about how much more interactive medical records are how much more you can do now with these data, it makes you wonder if maybe something could even be done almost automatically with the clinical documentation that translates parts of it into a format that's more useful to patients, or even just pulls out pieces of it for them and avoids, maybe, some of the duplication issues and so on.

But I don't know. This is a whole new frontier, so it'll be exciting to see what happens. But certainly lots more work needs to be done in this area.

Yeah, and on that note, I mean you certainly mentioned your next idea of talking to the docs. But where do you think this is going to be going in the future in terms of research, or just the movement towards getting patients more involved?

Well, I would love for notes to serve a more active purpose in patients' care. So they still need to be there for us to communicate with each other. For a bunch of different consultants and physicians taking care of a person and their family, we need to be able to communicate with each other, and the chart is probably always going to be there for that purpose. We can't always just be emailing and paging and calling people on the phone, and there needs to be a persistent record. None of us can remember everything we need to remember about the many hundreds of patients we see.

But could we build upon that in a way that actually allows us to meet some of the unmet needs that exist in cancer care? So for example, we know that among patients with advanced cancer, all of the studies that have been done on this topic suggest that most actually don't understand their prognosis. And they might, for example, think that their disease is curable when really, their chemotherapy is actually being given with just palliative intent to help them feel a bit better or maybe live a bit longer, but really doesn't have a chance of curing their disease.

And despite the fact that we all talk with our patients about their prognosis and treatment goals, somehow many people walk away from those encounters fundamentally misunderstanding it. So could we actually use the electronic records and this idea of open access to notes to somehow enhance what people really understand about what's going on? Could we use it to transmit information about prognosis in a way that's more understandable, or information about the treatment that people are receiving, what the likely side effects are, when they really should call for help, what the goal of that treatment is.

So it would be like taking these kind of standard, boring old things, like handing people you know pamphlets or pasting in bland educational text about neuropathy from chemotherapy, and turning it into something that's more active, or more interactive, to thereby improve patients' understanding, and thereby improve their care and their participation in their care.

No, it sounds fantastic. It's a really cool paper. And when I first saw it, I was excited to be able to talk to you about it because I think people will be interested in hearing your thoughts.

And Tom, thanks so much for talking to me today.

Well, thanks so much for having me.

And I also want to thank all of you out there who joined us for the podcast. The full text of the paper is available at ascopubs.org backslash journal backslash jop. It was published online ahead of print, February 13, 2018 in the JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell and co-authors Drs. Abel and Frosch discuss their editorial on public expectations in a shifting therapeutic environment.

Read the related article.

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca-- dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-us.com.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. What do most people think today when they think about a cancer diagnosis, about cancer's prognosis and treatment? Even if they've never had cancer themselves, most people either know someone who has had cancer, or they've been exposed to stories about cancer through the media. How do patient's preconceived notions about cancer impact their understanding of their own cancer diagnosis and their willingness to get treatment?

Joining me today to talk about this topic are Doctors Zach Frosch, Instructor in Medicine at Harvard Medical School and an Oncology Hospitalist at the Dana-Farber Cancer Institute and Brigham and Women's Hospital, and Dr. Greg Abel, Associate Professor of Medicine and Director of the Older Adult Hematologic Malignancy Program at the Dana-Farber Cancer Institute. We're going to be discussing their paper titled "What does a cancer diagnosis mean-- public expectations in a shifting therapeutic environment."

Doctors Frosch and Abel, thanks so much for joining me today.

Absolutely.

Nice to be here.

So given that oncology seems to be having a little bit of a renaissance in the media these days, with popular books such as Emperor of all Maladies and When Breath Becomes Air, this is a very timely topic to put this paper out here. How did you come up with this idea?

So Dr. Frosch and I were working on a survey where we're aiming to understand what the public knows about drug shortages in oncology, and we thought that a good question to have as a covariant for that survey was what the public thinks about cancer, in general, because we thought it would affect their answers to questions about drug shortages and what they would want to know and what they do know.

And when we ended up getting the results from the survey, we started to think about the question about how was cancer perceived, and we realized that it really is an important question in its own right. I'm have a lot more experience at this point than Dr. Frosch does, who's starting out his oncology career, but from both viewpoints it's interesting to think about what patients perceive, or potential patients perceive, about cancer can affect the interactions with oncologists and the interactions with the medical system.

I think that makes perfect sense. When I read this, it really resonated with me, although I don't often think about this when I'm starting to talk to a newly diagnosed patient, but maybe I should. Can you guys give me some example of how patient's perception about cancer before their diagnosis might impact their decisions on how to approach their own diagnosis and treatment?

Absolutely. And so you mentioned even before diagnosis, and I think it's important to think about how it starts even before a patient knows they have cancer, potentially even before they suspect that they have cancer. Because when people are worried about a cancer diagnosis, we know that they can potentially avoid physician visits or screening procedures that might make an early diagnosis when they're still asymptomatic. Or even when they have symptoms themselves, is their worry going to make them avoid going to see the doctor to get the diagnosis? And then even once the diagnosis itself has been made, if they have an unrealistically negative impression of what a cancer diagnosis means, if they believe it to be rapidly fatal no matter what they do, then they may defer potentially beneficial treatment.

And so it's really important to understand what they know and what they think they know about a cancer diagnosis. Actually interestingly, conversely, if they have an unrealistically positive impression of what can come out of cancer treatment, then they may make unrealistically aggressive decisions about their cancer care as well. I'm sure you and many of the listeners are aware of Dr. Week's paper on advanced GI and lung cancer from a number of years ago about patients who thought that their metastatic cancer was terrible, and so how was that, then, impacted. So it's really key to understand what patient's past experiences and what they believe their cancer diagnosis or potential cancer diagnosis could mean.

And something that actually just occurred to me when I was thinking about this is perhaps not even just the patient's perception, but even other physician's who aren't oncologists perceptions about cancer. I specialize in lung cancer, and it is not uncommon for me to see patients who are informed by the doctor in the emergency room or their primary care doctor that they needed to start getting their affairs in order, that they needed to start thinking about hospice. And we've got a lot to offer these patients today.

I think that's a very good point. Definitely, a lot of primary care doctors and other physicians who are not tied into oncology often have different perspective. And I think another perspective that's important to keep in mind is family members. Often, the perspectives are really colored by what other cancers they've been exposed to.

So I treat a lot of patients with myelodysplastic syndrome, which is a chronic cancer that people live with for a long time. But they're seen at a cancer center, and many patients will think it's like the pancreatic cancer that their brother had, and that's their exposure. So sometimes the family members and what cancers they've personally been exposed to, so I think both of those things come into play.

So, of course, we have patient's personal experience in their families, but what are your thoughts on how the media handles the perception of cancer and how that influences? There's certainly a lot out there about it, but is it really helpful to patients when they are learning about their own diagnosis?

Well, as Dr. Frosch mentioned, I think there's often unrealistically positive expectation, and that can be a problem, because sometimes those expectations won't or can't be met. Often, when media portrays or talks about certain treatments, they are discussed in ways that aren't clear, that they're only OK or worthwhile for certain subsets of patients. And so I think it's difficult sometimes for people to understand that that treatment may not apply to them, and it can lead to disappointments in therapy when patients aren't able to get that. They also may think they're eligible for things that they can't have.

And I think it's important we also talk about the media, just divided into direct-to-consumer advertising and marketing, and then, also, journalism. So I think that some of the journalism that we've seen has been better in terms of presenting a balanced story and changing some of the metaphors we use. We notice even with the recent Cancer Moonshot that we talk about as a moonshot rather than a war on cancer and some of those things. But on the other hand, a lot of the advertising we see for different medications in cancer can sometimes be subtly manipulative in ways that can affect patient's perception.

You mentioned the war on cancer, and that's something that comes up a lot in the popular media, as opposed to more journalism. But do you think this is a helpful metaphor? Or is this something that perhaps we'd be better off without?

I think that it can help people understand their cancer diagnosis and their treatment, and it may work for some people. But I think it has a lot of negative consequences in terms of when patients feel that they're giving up and losing the war at the end of life, when really we have a lot to offer patients in terms of hospice and end-of-life treatment. And again, it loops into that unrealistically positive expectation that maybe they're going to pursue more aggressive therapy because that is the metaphor that they should fight to the end.

So more recently, journey metaphors have become increasingly common, and we mention this in the article. And I think that may be a more helpful metaphor for some patients who then when it comes time that there's no more therapy to be offered, as Dr. Abel mentioned not everyone is going to be eligible or benefit from every therapy, they may not feel like they're losing the war. They feel like they're reaching the end of the journey, which, for many patients, may be a more palatable metaphor to use.

Yeah, it's not a simple concept. You could certainly see why people may approach this as a fight, but it definitely has consequences, as you mentioned. So I'm curious, can you talk a little bit more about the survey that you did? What are Americans' perceptions about cancer? Is there actual much data out there about that? And how has that changed over time?

Absolutely. So back in 2007 was the last time that we're aware that this question was asked. And in a national sample, they asked people whether they agreed with, quote, "when I think of cancer, I think of death." And the majority of the population did at that time. They really had that strong association.

And of course, since then a lot's changed. There's been a lot of new drugs and a lot of new advances. And so nearly 10 years later, we asked a similar but slightly different question. We asked people who've had different exposure to cancer and cancer treatment, some may have had the personal experience of cancer and others may have had exposure through family, friends, and the media, based on your experience, with which of the following statements do you most agree, and we gave them three options.

We said most of the time cancer is curable. Most of the time cancer is a chronic disease like diabetes, which can be managed. Or most of the time cancer is a rapidly terminal disease. And we had a different split than they did 10 years ago. Fewer than 50% of our respondents felt like cancer was a rapidly terminal disease, and many people actually felt like it was a chronic disease which can be managed.

And I think that is increasingly what we're seeing with new treatments. It's something that can be kept under control, even if it can't be cured, and that many people can live with cancer. And that rather than having it this binary split as something that is either curable or rapidly fatal, there's this growing middle category that we've seen.

I actually love that particular analogy, and I use it a lot when I talk to my own patients about living with cancer, even if it's incurable. And so I'm glad to see that there's evidence that that message is getting out to patients. So what can we as oncologists and as oncologists in training do to better understand our patient's conceptions of cancer? And how should we or could we help shape those perceptions in a better way?

So as we mentioned, everyone has had different exposures and experiences, so it's actually very hard to predict what somebody is going to walk into your office with, what their past experiences are going to have been. We really feel that the key is to ask them, understand what their past experience has been, and really ask them what do they think a cancer diagnosis means. And they'll tell us, and that will allow us to better engage with them, provide better counseling that really meets them where they are, and allow them to have a more realistic perspective of what they can hope for and what they might truly need to worry about.

That sounds like that would be helpful later on when you are having difficult conversations, help you to understand what the patient's perception is. Because if you don't take the time to know what they're thinking, they may be thinking something, as we discussed earlier, that their cancer's curable when, in fact, it's not, or they have expectations that are unrealistic, and you didn't even really realize that. So do you have any take-home messages from our talk today and from your editorial?

I just wanted to say that we're very thankful for the Journal of Oncology Practice for publishing this work. This is a hard topic to address with rigor. We did do a survey. One of the things that I was thinking about, as Dr. Frosch was reading the question, is that we had spent a lot of time with these questions and making sure that potential respondents understood-- it's called cognitive debriefing with survey work-- what we were really getting at. When we asked them about most of the time what do they think, we really asked them a general question about their perception of cancer, not the cancers that they know about through their own experience.

So this kind of work is hard to do, and I think the message here is that perceptions of cancer seem to be changing. One of things that we didn't really speak about yet in this podcast is the idea that if potential patients are now believing that cancer is not rapidly fatal, or the majority don't believe that, that should help people get to treatment.

I think there's still a lot of people who ignore signs and symptoms because they're very nervous that it means that death is around the corner, whereas maybe we're getting more a positive part of this, that there's been more messages in the media that cancer can be managed. So even if you do have a sign or a symptom that you think is related to cancer, it's not necessarily meaning the end of your life is happening. So I think that's a positive piece of this, and we're just very thankful of that JOP was interested in this work and to share it with others.

Doctors Frosch and Abel, thank you so much for talking with me today.

It was my pleasure.

Thank you.

And I also want to thank our listeners out there who joined us for this podcast. The full text of this paper is available at ASCOpubs.org/journal/jop. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell and Dr. Neha Vapiwala discuss the role of radiation oncologists be in the future.

Related Article: Care Provider or Service Provider: What Should the Role of Radiation Oncologists Be in the Future?

Support for JCO Oncology Practice podcast is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at astrazeneca-us.com.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JOP. The treatment of patients with cancer is increasingly multidisciplinary, with medical oncologists working very closely with their colleagues in surgery and, of course, radiation oncology, among other disciplines, to deliver the best care possible.

However, should all of the members of the multidisciplinary team share equal responsibility for patient care? Or is it OK if some of them operate more as consultants who perform services on request and then hand the patients back to their team? I think this is a very important discussion to have, both from a patient care perspective but also from the standpoint of professional satisfaction from the physicians who are participating in these care teams.

Joining me today to talk about this fascinating topic is Dr. Neha Vapiwala, Associate Professor and Vice Chair of Education as well as the Radiation Oncology Assistant Dean of Students at the University of Pennsylvania. She's going to discuss her paper titled "Care Provider or Service Provider, What Should the Role of Radiation Oncologists Be in the Future?" Neha, thank you for joining me today.

Absolutely, thank you for inviting me.

So I really like this. And it really struck me as an important topic that not many people are talking about today. So why did you feel this was something you needed to address?

Well, first, again, I'd like to thank you for bringing attention to this and to JOP for acknowledging our work. It is an uncomfortable conversation to have, in the sense that it's shining a spotlight on ourselves, something that we don't often necessarily think to do, as we are so focused in our various arenas of patient care and groundbreaking research and teaching.

But at the same time, it's something that, at least in speaking to my colleagues who helped co-author this, it was clear. Having this multidisciplinary world in which cancer care clearly has not just evolved but thrived and not addressing the fact that different members of the team may have differing stakes and differing roles. And are they the right roles, and is everyone contributing maximally based on their training and their interests?

It just sort of raised the question of re-evaluating radiation oncologists and the ways in which their role has evolved over time, which is part of what we try to talk about in this piece. And then not just on the history, but then focus on also where we are headed or where we could be heading. And in particular, all of these conversations have to happen with everybody at the table, not just amongst radiation oncologists in isolation.

I don't know if you can actually answer this question, but is there any data out there of how radiation oncologists see themselves in this particular discussion? Do they see themselves more as service providers, perhaps more like a radiologist? Or do they consider themselves to be longitudinal caregivers who want to follow their patients and manage their issues?

No, I wish I did have data that I could call upon to give you cross-sectional view of 2018, where we're at as a profession. But absent to that kind of collected data, I can tell you that, in terms of anecdotally and also in speaking to many colleagues, I think how radiation oncologists view themselves and the pride that they take in working on teams and contributing, from tumor boards to palliative care services and everything in between, certainly in the research realm, I think there's how we view ourselves and then there's how others view us.

And I do think there is a realization amongst many radiation oncologists that, because we don't often have inpatient services, because we haven't necessarily the schedule or perceived schedule that others may have, particularly in the surgical and inpatient medical oncology side, that that could be construed as not being as engaged, and perhaps rightly so.

And so those perceptions and sort of the PR of it, if you will, the way the aesthetics of it look, can work against us. Particularly those of us that are inclined to be more involved and to contribute more, there is almost these limitations that are placed by the nature of some of what we do and what we are allowed to do from a credentialing standpoint.

OK, well there's that aspect. And, of course, there's also a financial aspect. You know, radiation oncology is extremely profitable for most centers that include that among their practitioners. And whether those centers would want you guys to have time blocked off to manage medical issues is a question some centers may want to ask.

Absolutely, it's a brilliant point that we didn't elaborate on other than to say that institutions, the cancer centers, and the other providers would all need to, of course, have buy in to such a change in the scope of practice.

But you are correct that the nature of the reimbursement, at least as it has been historically-- who knows what the future holds-- but, yes, the nature of the reimbursement within the technical work we do is such that it's been what everyone's happy for us to focus on. And so, therefore, perhaps the impetus and the drive to do more beyond that could be seen more as caring for the patient has been limited because we're able to meet the bar just through the technical work. Yeah, that's exactly right.

But I would say, in your paper, you made some compelling arguments about why it might be important for radiation oncologists to be involved from the very beginning and longitudinally. So give me some examples that you mentioned in your paper?

Sure, yes, absolutely. So one way to look at this would be just if you simply look through the research lens. Obviously, right now it happens to be very topical, the role of immunotherapy and systemic therapy combination with radiation and how the two can be synergistic, if not at least compatible, and take advantage of the therapeutic window.

And that's not a new concept, but certainly burgeoning now with the advent of newer and newer systemic therapy agents. And so I feel that the role of local treatment with radiation is, in a way, from a research angle, become more exciting, more than ever before.

And so just as it's critical for the radiation oncologist to be at the table in the design of the clinical trials and the protocols and the grant proposals that go in, similarly, the care of those patients-- and in this case, I guess, study patients-- but the care of those patients and the toxicities and the adverse events that have to be monitored, there's a need for radiation oncologists to be able to own every piece of that and, of course, to work with the study team to be equal contributors in that realm. And so that's sort of an easy example.

When you start to try to translate it to clinical care, there is a lot about radiation therapy and the cancer survivor that is, for very obvious reasons, not something that your average primary care physician is necessarily going to be familiar with or know to look out for. And frankly, I don't expect that folks that are oncologists that aren't practicing or familiar with radiation would necessarily know some of the stigmata to expect or not expect depending on the radiation the patient did or didn't have.

And that alone, in terms of the service or disservice we would do to our patients if we don't follow them, is just one example that we cite here, in that we have given up sometimes that follow-up care to others. And part of it is pragmatic. You know, you can't have patients following with everyone all the time.

But at the same time, I think not having any continuity of care is also not the answer. And there are pockets of the country in which the radiation oncologist really does the radiation, provides that service, and doesn't see the patient again.

And to me, that's a lost opportunity, both for the radiation oncologist to contribute, for the other oncologists to gain from the radiation knowledge. And then for the patient, it's a loss in my mind. That's at least what posit here, this paper, that it's appropriate in some settings for the rad onc to really lead the followup if that was a primary form of treatment.

Right, in this realm where we're expected to be more and more productive in order to justify our salaries and our jobs, I think there's an aspect to just your own professional satisfaction of being able to follow your patients and take care of them as issues come along, and not just feel that you're there to come up with a plan to deliver a treatment and then pass them back to someone else.

Well, exactly, in a transactional manner, exactly-- and the learning that happens, I say to my trainees all the time. And this is not just for the rad oncs that we train, but also our med onc fellows and our surgical oncology fellows who visit with us.

I think it's really eye opening to see that patient who got radiation five years ago, six years ago, and what he or she is dealing with and how our current treatments might mitigate those side effects because we're doing things differently. If you don't see that, you don't learn from it. So there's a self-serving sort of educational value as well that can ultimately benefit the patients.

And so that example, and then the other was really inspired by, I think, our colleagues in the UK and Canada and elsewhere. They've really sort of taken the lead in terms of having radiation oncologists participate in inpatient care to a greater degree than we might traditionally see here in the United States. And one example of that is certainly palliative care.

Where I practice at the University of Pennsylvania, we have a fellowship trained palliative care specialist who is also a board certified radiation oncologist. And his engagement with the team and what he does for the care of these patients is an absolute resource that we cannot fathom living without now that we have him.

But for the longest time, it was not the case. And we just solely were the consultants and sort of came in and weighed in and signed off. And I think it's not the same as having our own service. But it's certainly a huge step towards taking a much greater role so that the burden does not fall solely on our surgical and medical oncology teams that often admit the patient.

No, I think that's a wonderful start to the discussion here. And obviously, this is something that both ASCO and National Cancer Institute, they care a lot about the true teamwork aspect of multidisciplinary care. And we devoted a whole issue of the JOP in 2016 to this topic. So how can we do better than we're doing right now at incorporating radiation oncologists into the multidisciplinary care team, from the beginning all the way through palliative care?

Yeah, I mean, I think that how we can go about this certainly is going to start with conversations like what we're having, and also through groups like ASCO, NCI, ASTRO. Through our organizations simply making it a priority that when decisions are made, particularly in this area of shared decision making and the informed patients who come into our clinics with reams of papers that they've printed off the internet, and providing that context.

And emphasizing that when there is any discussion of an approach to cancer, that there's a balanced view of it and that all the treatments have an opportunity to be discussed. And if the consultation is needed with the other specialists on the team, that everyone has that opportunity.

I think one of the ways in which radiation oncologists have had a tough time being on the care team is, again, if they're not the primary oncologist seeing the patient, a lot of times the description of the radiation treatment or its role is delivered by others. There's nothing wrong with that. But I think that there are sometimes details or aspects that simply don't get reviewed or discussed.

And how we promote that is, I think, facilitating, making these appointments and facilitating more timely access and standard access. Where groups of oncologists at a given practice from all different specialties decide, here's our pathway or here's our workflow. And here's what we want to do for a stage I lung patient.

We want to ensure that each of those individuals has an appointment with both the thoracic oncologist and the rad onc. And that should just sort of be a commitment that works from something as mundane as the scheduling to the tumor board discussions that allow everyone to speak up.

It sounds like a lot of what we're talking about here requires developing a culture of this teamwork where everybody takes responsibility and wants to share that. And that may be something that might be hard to create out of thin air, but might be a process.

Yes, a process. And there will be plenty of things where the way it's currently done is just right because the individual who ends up leading-- a captain of a ship, if you will, for the patient-- is ensuring that the other members of the oncology care team are being kept in the loop. And sometimes that is plenty, and that suffices.

But I think this might be a disease site per disease site conversation that has to happen from AKSM to ASCO to ASTRO, where you say, you know what? There's no head and neck cancer patient that should go without X, Y, and Z. And I think those kind of things, you're right, it's going to have to be shifts over time.

Well, thanks so much for joining me. This has been a great conversation. And I hope people tune in to your paper and our podcast. And hopefully this will initiate some studies to try to get more of a feel among the radiation oncology field as to how they feel about this topic.

Absolutely, and perceptions from all parties would be very interesting to collect.

Yeah, I agree. And I also want to thank all our listeners out there who joined us for this podcast. The full text of the paper will be available at ascopubs.org/journal/jop published online in the February 2018 issue of the JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Fumiko Chino talks with Dr. Aditi Singh and patient advocate Liz Salmi about how this essential tool for documentation could be optimized to be more patient-centered. This discussion will be based off the JCO OP article published in late 2024, "Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research," on which Dr. Singh served as the lead author.

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity. On today's episode we'll be discussing our friend, the Electronic Medical Record and how this essential tool for documentation could be re-envisioned to be more patient centered. This discussion will be based off of a JCO OP article published in late 2024 called, "Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research." 

I'm excited to welcome two guests, the first author, as well as a patient researcher advocate, to the podcast today. Both are passionate about improving how we use the EMR to communicate and provide care. 

Dr. Aditi Singh is an Assistant Professor in Clinical Medicine and Hematology Oncology with a focus on thoracic malignancies, particularly neuroendocrine tumors of the lung. She also serves as the Director of Clinical Informatics for the Abramson Cancer Center at the University of Pennsylvania. Her work focuses on optimizing the EHR to enhance provider efficiency and provide high quality cancer care. She also serves on the NCCN Guidelines Committee for non-small cell lung cancer, thymic malignancies and mesothelioma. 

Liz Salmi is the Communications Inpatient Initiatives Director for OpenNotes. In this role, she helps clinicians, hospitals and the health system understand the changing nature of patient-clinician communication in an era of growing transparency. As a person living with a malignant brain tumor, she is active in research and advocacy to ensure that the patient voice and patient-centered care is prioritized. 

Our full disclosures are available in the transcript of this episode. And we've all already agreed to go by our first names for this podcast today. 

Aditi and Liz, it's so great to speak with you today. I hope you guys are both staying warm. 

Dr. Aditi Singh: Hi. I'm very happy to be here. 

Liz Salmi: Thanks for having me back. 

Dr. Fumiko Chino: Our topic today is about how we make the electronic medical record more patient-centered. To start it off, I'd love to actually ask a hopefully non-controversial question to both of you. What is patient-centered care? How do you personally define it? Are there key characteristics or is it something that it's commonly mistaken for? Or is it like the Supreme Court's definition of pornography - 'I know it when I see it'? Liz, do you want to take that first?

Liz Salmi: Sure. Yeah. So, I've been living with a malignant brain tumor or a grade 2 astrocytoma for 17 years. And when I first got into this space, I'm a person with a communications background originally, so when I would hear that term, I'm like, "Yeah, of course, patient-centered care - like what were you doing before that?" And then in the last 11 years I've been working in healthcare and the last eight years specifically with the OpenNotes team at Beth Israel Deaconess Medical Center. So, when I would hear that term, I was like, "What were they doing before that?" Like still even more frustrated. So, it to me sounds like jargon, like a bad form of jargon. And I think that there's new words we could be evolving into over the next, say, decade, maybe sooner.

Dr. Fumiko Chino What are those words, actually, just out of curiosity? 

Liz Salmi:  I want to co-design that with patients. 

Dr. Fumiko Chino: I love it. So that's still a work in progress. I love it. 

Aditi, what's your take on patient-centered care? 

Dr. Aditi Singh: I couldn't agree more. It should just be synonymous with good care. It should just be very obvious. It's a no-brainer. In 2025, it's sad to me that when I was thinking about this question, I'm thinking, "Yeah, what did we do before that? What is it called? What is the opposite of patient-centered care? Shouldn't certainly not be provider-centered or like hospital-centered care." So, I'm all for it. I'm glad that this generation of medical students, nursing students, everybody's going through learning this concept, even though it should really be something just so organic. But I'm glad that we're putting an emphasis on it, that there is no other way. This is the only way of providing good care. The more agency patients have and for them to be empowered to fully participate in understanding their care, fully participate in their care, I think that's what it means to me. 

I think sometimes I see misinterpretations of it in the sense that, well, that means that everything the patient says I have to do as a provider. And I feel like it's a partnership, it's not a restaurant where they're saying, "Okay, I want that. And I just make this up." It obviously has to be within your professional understanding. You're still trying to do the best for the patient in front of you. But within that, because we know there's so much gray area in medicine, not everything falls neatly in our evidence-based guidelines and algorithms. That's really where all the nuance is and that's where we can do a better job at taking care of people, if we work together.

Dr. Fumiko Chino: Absolutely. I think you said the key word for me, which is 'partnership', because it really is. It's not like the patient as a consumer, it's a partnership. And I think patient-centered care for me really emphasizes this concept of shared decision making. And again, yeah, it blows my mind that this is like a newer concept that we didn't really, in the paternalistic world of healthcare, the patient was just sort of an afterthought. It was the receiver of care and not the person who was living with an illness.

Liz Salmi: Just to throw in there, there's a very well-known palliative care thought leader, Dr. Ira Byock, who wrote a book called The Best Care Possible about patient-centered care, we could say that, or 'the best care possible'. And it's a bummer that 'the best care possible' was coined and really developed by a palliative care doctor. And I hope people in the oncology community will pull a page from the playbook of all of palliative care, because to me, all of oncology care should be palliative care and that's disease treatment but also pain and symptom management. So, I just got to throw that shout out to all of palliative care in this podcast. 

Dr. Fumiko Chino: 100%. I feel like there's a lot we can learn from palliative care for pretty much everything that we do in medicine, including enhanced communication.  

Aditi, do you mind giving us a quick overview of the article that your multidisciplinary team published in JCO OP last year about how to make the EMR both more patient-centered but also work better for research and surveillance? I'd also just really love to hear about how you got interested in this topic altogether.

Dr. Aditi Singh: Yeah, absolutely. So, the National Cancer Policy Forum convened this workshop in 2022. It's a two-day workshop which focused really on improving EHRs for oncology care, surveillance and research. And we had discussions and talks from various stakeholders, experts in their fields, just putting our heads together and hoping for a better way than what we have. I think there was general agreement that we are very glad for EHRs as an advancement over paper records, but I think we all kind of felt that EHRs haven't really realized their full potential in all the great care that can come through them. And we all identified certain challenges that EHRs have brought with regards to EHRs really being formulated as primarily billing scheduling tools in the 1970s, and now it's this all-encompassing system that we use to do everything. All of our interactions are through the EHR, kind of this like thing that comes in between, sometimes we feel, like us and the patient. As providers, we talk to different stakeholders like oncologists and providers, patient advocates, patients, the federal agencies, EHR vendors. So, all of us kind of coming together, researchers, quality improvement advisors, to really figure out what are the challenges and what we can do moving forward to get to a better place. And I think my own personal journey on how I got interested in EHRs and how to use them to kind of harness their power, so to speak, to provide better care and to improve provider wellness was another one. 

I trained in India. My medical training was in India, where the system is fairly traditional and paternalistic. And then moving to the US and seeing just a lot more time spent with patients and involving them in general, there's a lot more we can do. But just coming from a place where there wasn't as much of it, it was really cool seeing that. And then through my training, just watching my colleagues struggle with how much we had to interact with EHRs. I think none of us went into medical school thinking that I'm going to sit in front of a computer all day and spend less time actually talking with my patients or always have this thing in the background when I'm talking to my patients. And so, I think seeing my colleagues and myself struggle through that and hoping for a better way to just achieve that "work-life balance," or doing what you love without getting bogged down by the administrative tasks that just keep piling up. 

And then I think my own life and my own struggles with fertility, having a late miscarriage, having a traumatic birth, and then now being a parent, once you're on the other side, it changes the way you think about these things. And I think being a patient can be so lonely and so scary. Here we're talking about cancer, and you're so vulnerable in that moment. Even as a parent, I say, you know, all your medical training goes out the window when you have a loved one that's sick. You both have beautiful stories on how you've learned from your own experiences. So, I think that was truly telling, that it changes the way you see the person in front of you once you've experienced it yourself. So, I think that's how I got into this space to hopefully move forward.

Dr. Fumiko Chino: There's a quote from the paper which was, I thought, was very telling, which was that "EHR development was driven by regulatory requirements rather than a focus on the user experience." So that's either providers or patients. They're both using the EHR, correct? It was not really built for either of us on either side of the computer, basically. And so, I love the idea of how there could be steps along with each kind of stakeholder to make things a little better. 

Liz Salmi: One thing I didn't necessarily see in the paper was that patients are actually the biggest user of the EHR through the patient portal. And so that needs to be acknowledged as well. And as you said, Aditi, like the user experience of these portals, is not great for clinicians and it's terrible for patients as well. So, I think both patients and clinicians can come together to co-design the future of that user experience for sure.

Dr. Aditi Singh: 100%. 

Dr. Fumiko Chino: And that actually segues directly into my next question, which is Liz, to kind of start off by saying, congratulations, you just won this recent award from the Society for Neuro-Oncology. And I know that your day job and your personal passion is to improve communication between providers and patients with this kind of central tenet that patients should be both encouraged and supported to be fully engaged with their medical care. Do you mind just kind of briefly discussing your career arc and how this really intersected with your diagnosis and your medical care for a malignant brain tumor? I know you mentioned a little bit already. 

Liz Salmi: Sure, yeah. None of this is pre-planned. It's just all happened. I think clinicians perhaps come into medicine, maybe not all of us, but "Oh, I want to be a doctor." And then you kind of figure out your path along the way and how you become leaders. I mentioned earlier that my background originally is in digital communications. And then at age 29, I had a massive grand mal seizure and then found out I had a brain tumor. And then jumping ahead, you know what I'm doing today and I can fill in the gaps. But today I work on the OpenNotes team at Beth Israel Deaconess Medical Center, which is one of the Harvard Medical School teaching hospitals. But the OpenNotes team, we've got researchers around the country and around the world, are really focusing on how transparency and transparent communication improves care. And so, when it's some defining words, we say when a clinical note is shared with patients, they become an open note, lowercase. And then our team is OpenNotes, a proper noun. And so, for the last 12 years, and this is before me, I've just been the last eight years, but for the last 12 years, we've kind of created this new field that's focused on research around how open and transparent communications improves relationships between clinicians and patients. And we just remain motivated by evidence that shows that when healthcare professionals offer patients and families ready access to these notes, how that improves actually safety of care as well, because you can spot errors in the record or, you know, just have more open dialogue.  

And so how I got here, grand mal seizure, communications, digital design. Really just sometimes people become patient advocates quite often because maybe they had a bad experience, a terrible experience, and they want to fight the system or co-design a thing with the system. I had the opposite experience. I had great care. I just was so curious about what was going on from a neurological perspective, from a neurosurgery perspective, move along around the lines. And then things started to change when I became a patient. It was the 'do not google the information in your records' era. We're talking about the 2000s and then late 2000s.  

And then my magical change moment is when I had to change health systems and request a copy of my medical record to like the new location. They said, "What do you want from your record?" And I was like, "All of it?" I don't know what's in it because I had really never seen it before. And so, God bless Kaiser Permanente Northern California for really giving me all of the record on like a DVD. And I had to pay for that. And so, I, of course, as a curious person, just threw that DVD into my computer and started looking at a 4800-page medical record. And I was like, "Oh, my gosh. They've been talking about me this whole time." I'll try to summarize it now, but I just didn't know that notes were part of the thing. And so that ultimately launched me to the OpenNotes team, the OpenNotes journey. Finding out that researchers at other hospitals are starting to study that. And so, I was like, "How do I get involved in that movement?" And so here we are seven, eight years later for me being part of the team and they're so wonderful academic clinicians, it's all about teaching and like training the next generation. So, I've been taught and trained and now I'm involved in the co-design research. 

Dr. Fumiko Chino: You know, I think you're underselling yourself because you as a patient PI, I think you've been on the ground floor of this concept of we need to be co-designing research around the patient experience. You've won, as part of your team, multimillion dollar grants to study quality of life and even this, I feel like this most recent award and I am not trying to paraphrase the SNO Annual Meeting, but I think you had asked, "Oh, is there registration or something for patients?" And they're like, "No, this isn't for you." Advance six years later and they're giving you an award! So, I feel like you've been on the ground floor of all of this very important move towards collaborative work with patients.

Liz Salmi: Thank you for highlighting that. Yeah, I think what I've learned in this experience is if someone tells me 'No', I want to work harder to prove them wrong.

Dr. Fumiko Chino: It's that punk rock mentality.

Liz Salmi: There we go. 

Dr. Fumiko Chino: Now, there's been a lot of consternation from both institutions and providers regarding the release of test results immediately to patients via the 21st Century Cures Act. These releases may actually even come before the primary team has been able to discuss the results and their clinical context with the patient. And I know a 2023 JCO OP article showed that 75% of surveyed oncologists felt like the immediate release of clinical information had a negative effect on their practice and/or their patients. I've certainly personally seen how the immediate release seemed to have fostered some anxiety for some of my patients. And yet I truly believe, and this is a direct quote from the manuscript, "Health records fundamentally belong to patients." Liz, I'd love to hear your perspective on this because I know that you were a first author of an ASCO Education Book. The chapter was called "When Bad News Comes to the Portal: Strengthening Trust and Guiding Patients when they Receive Bad Results before their Clinicians."

Liz Salmi: Yeah, that was a fun one to work on. It's open access, I believe, so people can go find that. But in that book chapter, we cite a couple of papers, specifically one of the papers and anyone can look this up. It's in JAMA Open, so it's open access. But well, we cite our own paper or I cited our paper with wonderful people. I was like fourth author or something like that. So, it's not just me. Saying that, all of those caveats, we cite this paper called "Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal." And what we did with that study is we surveyed patients at four sites around the country and really, we learned, despite clinician reservations, about getting immediate access to these test results, 96% of patients still want immediate access to the test results. And that stayed true even among those who received non-normal test results. Could be scary. And we actually asked them, "How did this make you feel? Were you more nervous? And they said, "Yes, but we still want it immediately."  

Knowing that and knowing that we can't put the genie back in the bottle for Cure's rule and everybody has decided people should have access to their information immediately, there are benefits to people having access to the information. So, if it's a note thing, they can find errors in the record. When it comes to their test results, they can plan ahead. And I think in the oncology perspective, I believe for folks who have an active cancer diagnosis and they kind of understand their current experience like I do, I see these immediate results, I see the immediate MRI results and I'm like, "Yeah, I still know I have brain cancer. That is not surprising to me." But I think where things are kind of troublesome, is like a new diagnosis or somebody sees something through their primary care, general care setting and then something, probably an imaging result says something worrisome and then the patient is going to Google or use ChatGPT to kind of understand their situation. And I think that this is a situation where, and this was also mentioned in the ASCO book chapter where Daniel McFarland coined the phrase, 'truth jumping'. What do we do if people have access to all the information, they feel unsupported in their care. And I think that there's a way to mitigate that, especially in like primary care settings where the ordering clinician of that test, whatever that test is, can really create some anticipatory guidance around it and say something very simple when they're ordering the test and I'm pulling a quote directly from a book chapter and other things, but it's like, "I am ordering a test. You might see the result before me. You have a choice, patient. You can look immediately or wait to hear from us. And what questions do you have?" So really laying, "Here's what's happening. Now, I'm ordering the test." And so, it creates context around. 

Dr. Fumiko Chino: Aditi, do you have any additional thoughts about this? About, for example, how to release test results effectively? How could it potentially help or harm their relationship with their oncologist? 

Dr. Aditi Singh: Yeah. Before the 21st Century Cures Act, we all had the same reservations that, "Oh, my gosh, having cancer is hard enough! Hearing it through the portal and not through trained physicians or providers who know how to break that news with some empathy and context on immediately following it up with what's next is going to be so jarring for patients. It's going to create so much anxiety." And I kind of still believe that. Yes, I've seen people who've gotten their results and it has created anxiety and it has been stressful. But at the same time, I think that's their choice. They get to decide that. We're all adults here. Obviously, it's different when you're making a decision for someone else. But we're taking care of adult patients who get to choose. And now you can give, just as Liz said, actually setting expectations as the ordering clinician and saying, "I'm going to order this," and, again, as an oncologist, most patients, like Liz said, it's really about, "Is my disease progressing? Is it back?" And patients have understood that they can read that if your impression says, 'no concerns for cancer', you kind of get that - they are like, "Okay. I'm good." Or if there's something concerning, you understand that, and it's not mind blowing. You kind of know, well, there was a percentage of chance that this would be good or bad. I think setting expectations, especially when we think it might be a new diagnosis, that this could be something that is as bad as cancer. If you are getting a colonoscopy, a screening colonoscopy, and we find something there, and the pathology is looking for abnormal cells or cancer cells, you can opt out and say, "I don't want to look at this," or you can. The other thing I encourage patients to do is just kind of see when their next appointment is scheduled because, I for one, as a patient would hate that I see something online and now I'm not seeing my provider for the next two or three weeks. So, giving enough time, a reasonable amount of time for the test to be read so that I am prepared, so I have had a chance to look at it for the patient so we can have the best discussion. 

But at the same time, once the patients understand that, and I think many patients do now, and I have both types of patients, some people say, "I don't look at it until you tell me." And there's people who look at it and then there is a lot of sometimes back and forth and we try to set these expectations that if this is something bad, if it's something really bad, where I need you to come to the emergency room right now, you're going to be hearing from me. But at the same time, it's nice that patients have that agency where they can say, "Hey, I just want to make sure I didn't get missed because I know you get a lot of test results and I hope you saw this, but this doesn't look good." You're empowering patients again to fully participate. And if you are someone who finds it helpful to ChatGPT or Google, from reliable sources- that's another thing, as a provider, I can give them reliable resources like, "Hey, this is a good website. This one, not so much. You can look at it and then you can come prepared for your visit and say these are the things I looked up. I have some questions now that I can better participate in this conversation."  

So, I think in general I firmly believe that the patient health record really does belong to the patients. They get to decide how and when they want to look at these things. But just as providers, we can help them set appropriate expectations and boundaries. And we sometimes get a lot of back-and-forth messages and we have to say, "Hey. This is non-urgent. I promise I'm going to talk about this at our visit. But just to provide good care to all my patients, I can't be in a back-and-forth kind of text message about this result." 

And then the other thing is that we can now use cool new technologies like natural language processing and these large language models where we're looking at- one of the things we get a lot is, "Oh, my God. My esophagus has collapsed." Because that's the normal way for the esophagus to be in the body unless you're eating. So, it would be nice if maybe we could have cool technologies where someone can hover over their test result and kind of translate this to me in something that a layperson can understand who's not in medicine. That includes that your esophagus is collapsed, which is its natural state. Nothing to worry about. So, some of these things we can do better with just technology.  

And I think one other thing I'll say is the onus of all of this can't only be on the provider. I think we need to make sure that the providers are supported to do the right thing because it is the right thing to provide patient-centered care and give patients the answers they want and help them through their journey of whatever diagnosis they have. So, if you have competing interests where there's profit-based companies telling you, "You need to fit in more patients and you need to see 30 patients a day and you need to make sure you bill appropriately." Because none of us are thinking that way. We went into medical school to help people and interact with people. But if you don't give providers the time, they need to have these discussions, the support for some of these questions to be handled by their staff and it can be a triage nurse who can then immediately call the patient and say, "Hey. Don't worry. Dr. Singh looked at this report and she said that this part is totally fine. She's going to talk to you more about it," but you have to have a whole team that helps the provider do that for them. 

Dr. Fumiko Chino: One thing I think that struck me about your article was this idea that by providing more support to providers, so by making the electronic medical record system work better for providers, you are actually making it more patient centered. You are basically loosening up that chokehold that sometimes the EMR has on providers to actually give us more time to have those difficult conversations or to make those phone calls and not just to be constantly documenting. 

Now, Liz, I recently read one of your many research articles that you're a co-author on. This one was in a Medical Informatics Journal from 2021 and it showed that after OpenNotes implementation, oncologist notes overall seem to become a little longer and easier to read. Yet some consistent feedback I hear from patients remains that the use of abbreviations and medical jargon stymie their understanding of their notes and their results. Do you have any thoughts on concrete steps that we can do to improve the use of the EMR as a tool to provide patient-centered care?

Liz Salmi: Yeah, for sure. How do we make these portals more friendly? I mean, they're not friendly for the docs and clinicians and they're not friendly for the patients. I mentioned earlier, the biggest user of the EHR through their patient portals is patients, and so these portals have not been designed well at all. Things we can do to make that portal easier for the patient user, knowing that now we have access to this information, we're seeing our test results before our clinicians and then we're going to message our clinicians and ask them questions. Some health systems are actually implementing penalties on patients. Like they're going to get charged for these patient messages and that's still up in the air. But with that in mind and all of that context and the amount of information that's available, some concrete next steps are to get people on the portal before something bad happens. So the proactive thing, people are used to using these tools and then from there you kind of learn the rules of the road or like what's okay or not okay or you kind of learn a bit about, "I know this question could be better asked in the clinic as opposed to through the portal because I've been dinged in some way." And it's unfortunate to get dinged in some way through those portal things. Or it's like if you keep asking me more questions, this becomes some sort of a digital visit and you might get charged for this. So, like figuring out that murky space, I feel like I'm talking about in a horrible way, but that still is like a place where getting things figured out. 

And then the thing is like the things that people like to use, things like social media are sticky and are pretty well designed. The patient portals have not been well designed. Can we pull a page from the playbook of digital tools that are working well that people like? And so that's like another ripe opportunity for co-design. And the people who build the patient portal tools, the people, the EHR vendors, I go to their conferences from time to time. Sometimes I have an abstract that gets submitted and then I get to learn what those vendors are doing and they don't partner with patients in the co-design of those things. I'm just talking about they in general but you can kind of guess who I'm talking about. But they are early phases of you know when I am at the conference and I'm the person who stands up and asks the room, "Did you involve patients in the co-design of your tool?" And they're like, "We're figuring that out." And so, it's sad that that hasn't happened. So, we could say it's sad for the clinician side but definitely sad from a patient user side especially if like that some of the systemic issues from a clinician strife perspective is, "Ah, my patients are over messaging me." 

And then another thing is we could bake in, we should be doing studies of how people are, especially people with cancers and kind of scarier conditions that make you message more, bake in things about studying what kind of maybe AI related tools to help us when we're in those kinds of scary situations. So, you know, shout out to our team as we are kind of focusing on some studies on that right now. But of course, the study is in progress and I would love to tell you the results right now and then I can't. So, it's like how do you kind of give really from a dissemination perspective how do you kind of say, "We're in progress, this is what we're learning so far." And so, from the 'what can we do right now' perspective as all of these things are going on, the Cares Act has happened, patients can see their test results. But something that has been well studied at least in the OpenNotes universe is we know from 12 years of research and 12 years of studies on the concept of when patients read their notes, they better understand their care and are more likely to follow up with what their doctor said, there's a whole body of work there. And the big tips are to patients and things you could communicate to patients are after the visit's over, reread your note. That is the concrete conversation. That's everything we talked about today. Read it. Encouraging reading your notes after a visit. And then another tip from Liz, super patient advocate, is before your next visit, read that last visit again. It may have been three months, it may have been six months, it could have been a year. Read that before your next visit. Because I know hopefully the clinician is doing that like 10 minutes before the visit. But it's like I'm going to read that and go, "Oh, this is what they said. I totally forgot that. I actually didn't do that or I did and it hasn't been fixed." So, the idea of reading the note and then reading it again later because that's what the clinician is doing as well. So, it really kind of puts us all on the same page. 

Dr. Fumiko Chino: I love it. Aditi, I'd love your perspective on this as well. As a provider, as a researcher, I think fundamentally we often don't think of notes as being education tools for patients and we need to balance this patient-centered care with other advances. Even in your paper, we're trying to get advances in quality surveillance and research. But again, there's this concept that maybe those advances in those things can be very patient centered as well. Where do we go next for this?

Dr. Aditi Singh: Yeah, the culture shift. Because I know a lot of people have said, well, these notes traditionally were not really patient facing. So, we would write a lot of things and sometimes we would take it just too far where sometimes, like I can't understand what my colleague in ophthalmology is saying. I've tried to interpret sometimes hearing tests and I was just like, "Wow, I don't know your abbreviations. Mine are different from yours." And so, I think it's a good thing that we're in general saying that these notes should be more readable because for everybody, even within the medical community, I think there's been an issue with note bloat. And some of our notes, especially oncology notes, and there's been research on this, are just some of the longest, not necessarily the best quality, notes, but just very long where it's just really hard. When our patients get admitted to the hospital, sometimes a hospital team has a hard time understanding what was going on outpatient. Your note goes on for 30 pages and I can't find out what I need to find out. And same thing for patients. So, I think, in general, it's a good thing to just push increased readability and just teaching medical students and us, as hard as it is to change. But it's a good reminder for me and say, "Hey, I wrote this. Does this make sense to someone who doesn't practice oncology?" And if it doesn't, how else could I say it where it doesn't necessarily take me an extra hour finishing my note, but it's still succinct. It's not going to have all the education that patient needs. I'm still going to have supplementary material that is very specifically patient facing because it will have more information. And then I still have my people resources, my human resources that are going to do a, say, chemo teach visit for someone who's starting a new therapy. And I have my pharmacist who's going to do that, too. But how do we use all of that so that the patient in front of me feels as prepared as they possibly can to get this treatment, go through the scanxiety that comes with scans and go through this journey feeling that they have some sort of– We're all looking for that sense of control where we have none in some of these situations. So just helping each other out this way.  

So, I think, yes, absolutely, need to make our notes more readable. We can do some of it ourselves, some of it our technology does. So, we have an autocorrect in our EHR that I use heavily and I still sometimes will write in shorthand and it just auto corrects all the words that I'm used to writing in and it just fixes all of that for me. So, use the technology. And some things we're learning too, and we talked about this in our article too, how certain things we said were using stigmatizing language, sometimes inadvertently, and how some of these biases get perpetuated. And we've just been saying that and now someone said it in a different note that got copied and pasted and now we've just perpetuated this thing that was completely inaccurate about the patient. So absolutely, more power to patients to read that and say, "Uh-uh, that is actually not what I said. And actually, can we have a meaningful conversation on what this meant?" So I do think we can do better as a community and I think if we and the EHR vendor, if they continue to use these newer technology, a lot of us are testing ambient listening and I think that'll be really cool because if I can just sit and look at my patient and not have to type anything, and I have this AI tool that kind of summarizes our interaction and makes sure that we put in all the important information in that patient's note. And then it's a great reference, like Liz said, for the patient and for me when I look at that note next time.  

Because there's also research that's shown what the patient says and what you actually type is often you just filter out so many of the things because I'm in my medicine brain, you're filtering out as people are speaking because you're also trained to recognize the worst-case things and, "Not dangerous, not dangerous, not dangerous. Okay, I'm going to write the one that sounds- chest pain. I'll write down funny tingling in your toe that happens like once every once in a while." I keep on going because I need to also focus on things that I think I can triage in my head. But this is cool. This way we get to hear the whole story and I think have more open-ended discussions as opposed to these short, "Do you have chest pain or not? Constipation, yes, or no?" But actually saying, "Hey, Liz. What's your story? Very different question. 

Dr. Fumiko Chino: And I think that just to kind of point to this concept of the patient reported outcome and the tingling in the toe that does happen every now and then but has consistently happened for the last 10 years. I feel like PROs can really potentially actually capture that better. 

I would just like to give a little last time at the end in case there's anything that we didn't touch upon that you feel like is really relevant or pressing before we say goodbye. 

Liz, anything that we missed?

Liz Salmi: Not a miss, but just a quick thing is a little bit about LLMs or AI tools in the exam room. And I just want my doctors to know that I'm also using those tools. And it'll be an interesting next few years as the patients are users and the clinicians are users and I don't want them to just talk to each other. So how do we design this stuff together?

Dr. Fumiko Chino: Sometimes I feel like patients and providers are just on the world's longest blind date. We're just trying to find enough about each other to have a meaningful relationship.

Liz Salmi: That's cute. I love that. 

Dr. Fumiko Chino: Aditi, any last thoughts from you? 

Dr. Aditi Singh: I love this quote by Ram Dass where he says, "We're all just walking each other home." We're a team. That's how I think most of us oncologists think. I love my patients. I want to do what's best for them. I think most of us are that way and I wish for our regulators, our payers, our healthcare systems, to all get on the same page so that- we want more of this. We want more of this interaction, that mutual respect and trust that is just invaluable. And we want all of those other stakeholders to come together and help support this. And I think that support's the biggest mission here.

Dr. Fumiko Chino: I love that. What a great way of ending this conversation. Thank you so much for this wonderful conversation. Many thanks to both Dr. Singh and Ms. Salmi, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. And I hope that you'll join us next month for Put into Practice's next episode. Until then, stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Dr. Eduardo Bruera talks with Dr. Pennell about the changes in type and dose of opioid prescriptions among patients referred by oncologists to an outpatient palliative care clinic.

Related Article: Opioid Prescription Trends Among Patients With Cancer Referred to Outpatient Palliative Care Over a 6-Year Period

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-us.com.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Now, overuse and abuse of opioid medications in the United States has become a huge public health problem, and efforts to reduce the misuse of opioid prescriptions by physicians is a major part of efforts to combat the problem.

However, as we know in the world of cancer care where we're all practicing, opioid medications represent some of the bread and butter tools that we use to control cancer-related pain for our patients, and we want to make sure that these are available when we need to use them. So how does the national opiate epidemic impact opiate prescribing for cancer patients?

Joining me today to talk about this topic is Dr. Edgardo Rivera, Professor and Chair of the Department of Palliative Care, Rehabilitation, and Integrative Medicine at MD Anderson Cancer Center. We'll be discussing his group's recent paper "Opioid prescription trends among patients with cancer referred to outpatient palliative care over a six-year period."

Dr. Rivera, thank you for joining us for the podcast.

Thank you very much for inviting me.

So I know this didn't go into this very much in your paper, but can you talk a little bit about the scope of the problem with prescription opioids? Why is this such a major issue that needs to be addressed?

Yes, there has been, clearly, an increase in the number of opioid-related serious adverse effect events and deaths, and a lot of those are prescription opioids. And so there has been increased awareness of the size of the problem and the fact that prescribed opioids are associated with at least a significant proportion of those severe side effects and deaths. And so there have been a number of measures that have been implemented by federal and state organizations that are likely to impact the prescribing behavior by physicians.

What kind of regulatory controls have been put in place?

Well, perhaps the first major step was the rescheduling of hydrocodone that happened to be the most prescribed opioid, and also the most prescribed drug in the United States, to a schedule II opioid in October of 2014, followed by the CDC guidelines on pain management with opioids that excluded cancer, but it had strong recommendations about side effects that, of course, were applicable to cancer.

Also, the surgeon general letter to all physicians practicing in the United States that was a very, very strong message about the problem of opioids. And I guess, finally, the recent declaration by the president of the opioid crisis described as a public health emergency in the United States. So all these measures are likely to have significant impact on the way oncologists and other specialists assess and manage cancer pain.

And I know that many of these regulations specifically tried to exclude cancer patients, or at least make them somewhat of a special category. But it sounds like from your group's perspective, you're still worried about potential risks for our cancer patients and their ability to access these drugs.

That's correct. Our hypothesis was that since there has been this very, very significant increase awareness and also some vigilance at multiple levels about opioid use, including the, of course, mandated in many states and recommended in all states checking for multiple prescribers in every state database, we felt that this might have impact on the way patients were receiving their opioid prescriptions. And so that's the hypothesis that we had, that is that over time we would see a reduction in the overall amount of opioid prescribed to patients before they were referred to a supportive care program.

Oh, that makes perfect sense. So can you just tell me a little bit about the design of your study? How did you do this?

Yes. We wanted an inception point, and the one we chose was the moment in which the patient was referred to the supportive and palliative care program. And what we did is we determined the total morphine equivalent daily dose that patients were receiving at the moment of being seen in consultation by the supportive and palliative care team between the years 2010 and the years 2015. So we reviewed a total of 750 patients that were referred in each of those years to determine not only the amount of opioids they were receiving by their own oncologist at the moment of referral, but also the type of opioids to see if there had been any modification in the type of opioids.

OK, well, that makes perfect sense. And so what did you find?

What we found out is that every single year between 2010 and 2015, there was a reduction in the overall opioid dose that those patients were given by their oncologist at the moment of referral to palliative care and supportive care. The reduction went from approximately 78 milligrams of morphine equivalent per day by the year 2010 to about 40 milligrams, that is, about half by 2015 at the moment of referral.

Well, was there a change in the overall amount of opioids that were being prescribed to the number of patients who received opioids during that period?

Well, that's a very important point. There was an overall reduction in the dose that each of those patients was receiving at the moment of referral. There was also a modification in the type of opioids. So there was a significant increase in the use of tramadol that is a non-schedule II opioid, and there was a significant reduction of fentanyl and hydromorphone that are two schedule II opioids. So we noticed that there had been both a reduction in the overall amount of opioid that these patients were given, and also a trend towards using the weaker opioid that are under less stringent regulation.

That's very interesting. So do you think this was due to just an increased awareness of the opiate overuse epidemic and the concern over overuse of opiates?

Well, this is a very important question that you're posing to us. What we are convinced by our findings is that the medication prescription, the opiate prescription by oncologists has changed, and it generally has decreased. Now, there are perhaps three main possible explanations.

One of them is that there has been a reduction in what might be perceived as overtreatment before. Some people might be getting a bit more than they actually needed or with a little bit less vigilance. The second possible explanation would be that there is currently an under-prescription and that people, maybe they're not getting what they might need.

And the third explanation is that some of the oncologists are choosing to refer their patients to supportive and palliative care for opiate management due to the increased complexity of prescribing these drugs, sees their needing to check the state data bases and also there are sometimes difficulties by issuers and pharmacies with filling those prescriptions. So there are clearly some barriers that exist now that were not present five or six or seven years ago, and our impression is that rather than having curtailed overtreatment, oncologists are finding the barriers difficult in their practice, and they're choosing to perhaps take advantage of colleagues to manage the patients a little bit earlier than they were before.

So that actually could be considered a benefit to this whole process if, perhaps, patients are receiving earlier or more broad use of palliative care experts. So do you think that this is leading to under-treatment of patients, or perhaps just more judicious use of the pain medicines that are available?

Well, you're posing a wonderful question, that is, the impact might be different in different places. In places where supportive care programs are available, then this might be one way to get those patients earlier access to this integrated practice between supportive and palliative care and oncology. Unfortunately, in places where those services are not available that are still the majority in the United States, this might mean that perhaps some of these patients might have a little bit more difficulty accessing the type and dose of opioid they might need. Of course, we need to do a little bit more research on this, but I guess it suggests that unless the supportive and palliative care programs are available, oncologists are a little bit more reluctant to prescribe.

Well, that's pretty concerning because, as you said-- I'm lucky to work in a place with very good palliative care departments at the Cleveland Clinic, and I know that, obviously, MD Anderson has a wonderful department there, but many patients in the United States don't have access to that. So where do you think this is going in the future? I don't think that we're likely to see less of a focus on prescribing opiates over the next five or 10 years. How are we going to protect the patients and make sure that they're getting adequate treatment?

I think this is a wonderful point, and I think ASCO has already issued what we believe is a very useful guideline, specifically in the case of cancer survivors. And I think a number of organizations, including ASCO, are working, making sure that oncologists feel safe prescribing opioids for the initiation of cancer pain management in their own patients, feeling safe and comfortable doing so. And I guess there will be need to educate our leaders and basically clarify that the vast majority of cancer patients adhere to their prescribed opioids, and opioids continue to be the most useful drugs for the management of cancer-related pain.

So there will be need for some advocacy, and that's already starting to happen, and also to make sure that our oncologists feel safe and that their practice is emphasized, it is supported so that the contact with supportive and palliative care is important. It will always be necessary, particularly when the pain does not respond well, but the right and the autonomy of oncologists to prescribe opioids will have to be present for many, many years to come.

All right, well, Dr. Rivera, thank you so much for joining us today.

Thank you. Bye-bye.

And I want to thank all of you out there who joined us for this podcast. The full text of the paper is available at ASCOpubs.org/journal/jop published in the December 2017 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. Thanks for listening.

Dr. Pennell discusses survival as an important indicator of the quality of cancer care with author Lawrence Shulman.

Related Article: Survival As a Quality Metric of Cancer Care: Use of the National Cancer Data Base to Assess Hospital Performance

Support for JCO Oncology Practice podcast is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-us.com.

Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic and Consultant Editor for the journal. Over the last decade, there's been an important movement to try and improve the quality of medical care in the United States. But to do that, of course, we have to have reliable measures of quality.

But how do you really do that? Is it enough to measure compliance with guidelines or expert recommendations for high quality care? Ultimately, you might think that high quality care should lead to improvements in survival for cancer patients. And naturally, that leads to the question of whether survival could be used to compare the quality of care between different practices or different hospitals.

Joining me today to talk about this topic is Dr. Larry Shulman, Deputy Director for Clinical Services of the Abramson Cancer Center at the University of Pennsylvania and leader of the Cancer Quality Program for the University of Pennsylvania's health system. He's also the former chair of ASCO's Quality of Care Committee, former chair of the Commission on Cancer's Quality Integration Committee, and currently the chair of the Commission on Cancer.

Today we'll be discussing his recently published paper, Survival as a Quality Metric of Cancer Care, Use of the National Cancer Database to Assess Hospital Performance. Larry, thank you so much for joining me today.

Thanks for having me.

So can you give us a little bit of background? What are the some of the challenges in measuring quality of care, and what led you eventually to do this study?

Well, a decade ago, we were doing very little to measure the quality of cancer care in any respect. And then ASCO, in the early 2000s, started the QOPI program. And at around the same time, the Commission on Cancer began a quality program as well. And as you mentioned, most of the quality metrics that are included in those two programs are process measures, that the patient with a certain stage of disease get the appropriate treatment and so on. And those are very important metrics, and we've learned a lot from measuring those.

But at the same time, people have complained, including the public and the regulators, that we really need to know outcome quality measures. And the most important outcome measure for many people is survival. And survival is really, presumably, a culmination of all the aspects of care, not just whether you gave a particular treatment, but the other aspects of care that help patients to either do well or not do well. So that appeared to be an important measure.

I will say that there are a number of centers around the country that published their own survival metrics on their website with a variety of comparisons. And we were concerned that that was not really truth in advertising, and we wanted to understand measuring survival at the hospital level and also at the a hospital type, the class of hospitals. And that's what led us to do this study.

And that makes perfect sense. I mean, ultimately, when you're just measuring metrics, perhaps through ASCO's QOPI program, ultimately you're making an assumption that that's leading to better outcomes. But it would be nice to have some proof that that was true.

So could you please walk us through your paper a little bit? So what were you trying to accomplish with this particular study?

We queried the National Cancer Database. The National Cancer Database includes cancer registry data from 1,500 hospitals across the US that are accredited by the Commission on Cancer. And our estimate is that that covers about 70% of the cancer patients in the country. So this is a very robust database, and currently there are about 36 million patients in this database.

So we decided to look at patients with two different diseases, and we had very specific reasons for including them. We looked at patients who had Stage 3 breast cancer, and we did that because those patients ordinarily receive surgery, systemic therapies, and radiation. And we wanted to assess some disease where all the modalities were involved.

In addition, most of the technologies that we need to treat breast cancer patients are available at hospitals throughout the country, community hospitals as well as academic centers. The capability to do good breast surgery, give the types of systemic therapies we give for breast cancer and radiation, are widely available.

We also chose advanced non-small cell lung cancer, and we did that because that's a changing paradigm. The use of genomics to identify patients who have targetable mutations is not widely used throughout the country, and we wanted to see whether there were differences that we could assess in different hospitals and different hospital types.

And so what we did was we looked at both unadjusted survival, which is basically how many patients were cared for with a particular disease, and the death rates. And then we also looked at risk-adjusted survival because the patient populations are not the same at all hospitals. And so we risk adjusted for a number of variables, including age and gender, ethnic background, socioeconomic status, comorbidities, and insurance status.

So I won't ask you to delve into the details of how the analysis was done, but what did you find?

So we found three major points. One is that we looked at survival at the individual hospital level across the 1500 hospitals. And when we did risk adjustment, we found that very, very few of the hospitals had survivals of their patients that were either statistically better or statistically worse than the mean. And in fact, it turned out to be about 15 hospitals out of the 1500 hospitals that had survivals that were statistically better or worse.

And there are two reasons for that. One is that the survivals were in a pretty tight distribution, so that there wasn't a wide splay of survival differences among the different hospitals. And secondly, even large hospitals, comprehensive cancer centers, have relatively few patients with a particular stage of disease that can be assessed for survival.

So we felt that at the individual hospital level, this would not be a good quality metric to distinguish levels of care, and that some of the people who have argued for using survival to ultimately assess the quality of care of a hospital, this is probably not where we want to go.

The second thing that we found was that we looked at hospital types. So we aggregated hospitals into four groups. One was NCI-designated Comprehensive Cancer Centers. The second were academic cancer centers that were attached to a medical school and a training program. Third was large community hospitals with more than 500 new cases a year. And the fourth were small community hospitals with 500 or less cases a year.

And what we found was that when we aggregated those hospitals by these categories, there was a difference in survival. And the best survivals were seen at the NCI centers, followed by those in the academic cancer centers. Third were the large community hospitals, and fourth were the small community hospitals.

We spent a lot of time with the editors of JOP trying to assure ourselves that the statistical evaluations were valid. And in the end, they felt they were valid enough, obviously, to publish the manuscript. So I really think that the findings are real. And the question is why is there a difference in survival by hospital type?

And this study doesn't answer that question, but I think it gives us enough information to ask the question and start to delve deeper into what might be behind these survivals. I will say that Peter Bach and his colleagues from Memorial Sloan Kettering published a manuscript a year or so ago that had very similar findings. So I think this is a real finding, and we need to deal with it nationally.

Yeah, I think that's interesting. And I know that's not the first time that something like this has been shown, although I don't recall seeing such a linear breakdown from small center to larger center to academic center to NCI Conference Cancer Center. Do you have any speculation about what might be happening, or what could be done to try to further dig in to that?

You know, I'd like to make one point before we get to that. And that is that the answer to the question of how do we deal with these differences can't be that all patients should go to NCI Comprehensive Cancer Centers. The answer should be, we need to figure out what the differences in care are and try to figure out how to improve the care in the community hospitals because patients, most of them, should be able to stay in the hospital near their home, and the NCI centers and academic centers don't have the capacity to treat all the patients in the country.

So we need to understand what these differences are. We are in the process of doing a very deep dive into some of the quality metrics that the Commission on Cancer uses to accredit hospital programs and correlate those with survival outcomes, again, by hospital type to see whether there are correlations between compliance with those quality metrics and survival outcomes. And that work is underway, and I'm hoping that the early analysis will be available soon.

No, I think that's a good idea. I know that breast cancer programs have to go through a fairly rigorous accreditation. And I don't know if that's something that's included in the NCDB about whether they're accredited or not, but it might be worth looking to see if that makes a difference.

So we actually do have that information. And there's the accreditation program, what we call the NAPDC, the National Accreditation Program for Breast Centers. And they tend to do a little bit better in some of the quality metrics that we haven't looked at survival in those centers. But to some extent, it's a self-selected population. People who are vying for breast cancer accreditation have a special interest and focus on that disease.

I'm glad you pointed out that when you talk about large databases like this and looking at populations of people, that this is not something where, if you're getting your treatment at a small community center, you need to immediately leave and go to a big center somewhere in a big city. You may be getting perfectly appropriate care where you are, and you can't extrapolate from populations like this to your individual doctor's practice.

That's absolutely correct.

So one thing that jumps out at this, though, is I do have the privilege, as do you, of working at an NCI designated Comprehensive Cancer Center. And I know that many of our centers put out these publications where they're really marketing documents that show our benchmarks survivals compared to, say, the SEER Database or NCDB. And the implication is that you're going to get better care and potentially going to live longer if you come to one of these centers. So what do you think about that, given what you found in your study?

Well, frankly, I think it's a bad idea. And in fact the Commission on Cancer specifically prohibits-- though not everybody follows the prohibition-- prohibits the use of the survival data in public reporting. And the reason we do that is because we think that the comparisons are really not valid. And the cancer centers that I know that have used that in their publications or on their websites have generally used unadjusted survival, which is even further from being valid than risk-adjusted survival.

So we would discourage that. We don't think that it's really truth in advertising, quite frankly. And it's against the Commission on Cancer's formal policy to use NCDB data in that way.

So what would be your take home message from your study? Do you think that survival is not going to pan out as a comparator from practice to practice or hospital hospital? Or is this just not the right way to look at that?

No, I think that's correct. I think that we need to tell the payers and the government and other regulatory agencies which are thinking about ways to assess the quality of either practices or hospital programs that at least currently, we don't think that survival is the appropriate metric. But we do think that it raises a red flag for how care is being delivered across the country.

And we do think that it's our obligation as a profession-- and I think the oncology profession should take this initiative-- that we need to figure out where the opportunities are to assure patients who walk into any hospital in this country that they're getting top level care and have an equal chance of survival as if they walked into another hospital or a Comprehensive Cancer Center. I think, as a profession, we need to take these data seriously and act on them.

Is there anything we didn't cover that you wanted to make sure we highlighted from your paper?

The only other thing I would say-- and this was a little bit of a surprise-- again, we chose breast cancer because everything should be available everywhere, and lung cancer, maybe not. But the findings were identical for the two diseases. So we didn't see any difference in the breakdown of likelihood of survival by hospital type for breast cancer or advanced non-small cell lung cancer, for whatever that's worth.

So I think as we start to delve into what the factors are that drive survival, that we need to, again, take that into consideration. It's not just technology availability or not, but there must be other factors as well.

Yeah. The challenge of taking something like a pure clinical trial population, and then suddenly looking at an entire general real world population and trying to see if you're having the same levels of effects is something that I know everyone is interested in doing. We know in practice that it's a completely different scenario. But it's hard to delve into exactly what's happening to those patients in the real world.

Yeah. No, absolutely.

Well, Larry, thanks so much for talking with me today.

Thank you for your interest and for reaching out to me. And we look forward to the input from our colleagues as people start to read the manuscript, and also ideas from others about what next steps might be. So thank you very much, Nate.

And I also want to thank all our listeners out there who joined us for this podcast. You can read the full text of this paper at ascopubs.org backslash journal backslash jop, published online November 1, 2017. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

Dr. Pennell discusses practical ways toward a culture of kindness, transparency, and responsibility with author Dr. Anthony Back.

Related Article: What Enables Oncologists to Discuss Goals of Care With Their Patients? Practical Ways Toward a Culture of Kindness, Transparency, and Responsibility

by Dr. Nathan Pennell and Dr. Michael Neuss

Related Article: 2017 ASCO Quality Care Symposium: Nurturing a New and Growing Community of Practitioners

Read the associated article by Kline et al in Journal of Oncology Practice.

Dr. Robin Zon of Michiana Hematology and Oncology discusses the latest State of Cancer Care in America report, and the opportunities and challenges confronting the cancer care community.

Dr. David Jackman of Dana-Farber Cancer Institute discusses how after introduction of a clinical pathway in metastatic NSCLC, cost of care decreased significantly with no compromise in survival.

By Dr. Muhammad Beg 

Dr. Muhammad Beg discusses the challenges and next steps needed for physical activity monitors to provide relevant information that can change the current state of oncology practice.

Related Article: Promise of Wearable Physical Activity Monitors in Oncology Practice

Dr. Ray Osarogiagbon discusses the need for the development of "real" care teams for lung cancer patients, to foster coordination among the multiple specialists and staff engaged in routine care delivery.

Dr. Robert Miller provides an update on CancerLinQ (Cancer Learning Intelligence Network for Quality), ASCO's big-data, health information technology platform for oncology practices nationwide.

Host Dr. Fumiko Chino sits down with co-editor and health outcomes researcher Dr. Ryan Nipp, and contributing author Dr. Kelly Shanahan who is living with metastatic breast cancer to have a candid conversation about financial toxicity, the lived experience for patients, and what we can do to move the needle on affordability in cancer care.

TRANSCRIPT

The disclosures for guests on this podcast can be found in the show notes.

Dr. Fumiko Chino: Hello and welcome to the inaugural episode of Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. 

In today's episode, we'll be highlighting the special issue of JCO OP focused on financial toxicity. I'm delighted to serve as an editor for this special issue, and I'm overjoyed to welcome two guests who were instrumental in creating the issue. The first is my co-editor, Dr. Ryan Nipp. He's a Medical Oncologist focused on GI cancers at the University of Oklahoma Stephenson Cancer Center, where he also does cancer outcomes research. I'm also pleased to welcome Dr. Kelly Shanahan, who is an author of a narrative piece for this issue. Dr. Shanahan was a practicing OB/GYN in Lake Tahoe, California when she was diagnosed with stage 2B breast cancer in 2008. She has now been living with metastatic breast cancer since 2013 and serves as a patient advocate and research advisor. 

Our full disclosures are available in the transcript for this episode and we're all already agreed to call ourselves by our first names for the podcast today. 

Kelly and Ryan, so great to speak with you today.

Dr. Kelly Shanahan: Likewise, Fumiko. 

Dr. Ryan Nipp: Thank you so much.

Dr. Fumiko Chino: To start us off, I'd love to just set the scene about financial toxicity, our topic. Ryan, do you mind sharing an overview of financial toxicity, what it is, what it isn't, and how you got involved in this type of research?

Dr. Ryan Nipp: Absolutely. Thank you. So I always start with the idea that the NCI website, I remember when this came out a few years ago, they provide some helpful information on this topic. The definition that they provide I think works nicely. It states that financial toxicity describes the issues patients may have related to the cost of medical care. The high cost of medical care, in addition to the cost for missed work, loss of employment and travel and lodging for care, can cause financial problems and may lead to debt and bankruptcy. Financial toxicity can also affect a patient's quality of life and access to medical care. For example, a patient may not take a prescription medicine or may avoid going to the doctor to save money. Research also suggests that patients with cancer are at risk for experiencing financial toxicity potentially greater than people without cancer or other medical issues. Financial toxicity is also sometimes called financial burden, financial hardship, financial distress, financial stress, economic burden, and economic hardship. So it goes by a lot of different names. 

Throughout my career and my research to date, I developed an interest in financial toxicity as I'm particularly interested in improving care delivery and outcomes for patients impacted by cancer and this continually became an issue as I was growing and training in oncology, noticing that the financial toll of having a cancer diagnosis can be remarkably problematic and concerning for our patients. Thus, I wanted to find ways to study this issue and ultimately develop strategies to address the problem. 

So just to give a little bit of background on the current JCO OP special issue, we wanted to do this special issue for numerous reasons. We're fortunate to work at JCO OP or work with JCO OP, JCO Oncology Practice which has a unique interest in this topic. We've been working to address this issue of financial toxicity throughout our careers, I say me and Fumiko, and we felt that the current time represented a unique opportunity to take a look back and see what progress has been made, also, what problems are persisting. We are extremely proud of this special series as we've had numerous unique viewpoints captured and I think this series provides a relatively comprehensive overview of the current state of the science in this field related to financial toxicity and oncology. 

And looking back over our notes over the past couple of years, while we were planning this issue back in the summer of 2023, we had wanted to have a broad array of articles specifically focusing on the state of the science of financial toxicity, understanding the health insurance landscape, health policy issues related to this, cost of care discussions, social determinants of health, financial assistance programs, and financial navigations. We also wanted some unique perspectives on financial toxicity with regards to geriatric oncology, a global and international perspective, and we wanted to have as many articles as we can relate to the patient perspectives on this topic, which we've got very fortunate for. Specifically we wanted one to give an overview of the foundational work in this field. Number two, highlight knowledge gaps that still exist. And number three, compel the field forward to encourage interventions and innovations necessary to move oncology into a more equitable and affordable space. We are blessed to have so many phenomenal colleagues that were willing and able to share their experiences, expertise and insights for this special issue. So thank you. It was a long winded answer, but I'll stop there.

Dr. Fumiko Chino: I Love it. I 100% agree with you. I feel so blessed to have worked on this issue and it really is sort of where we are now, how did we get here, and what the future should hold, how can we be doing better for financial toxicity.  

Now, Kelly, your piece "Debt or Dying?" was a real highlight of the issue for me. Do you mind speaking on the lived experience of financial toxicity and how costs have really unfortunately driven some of your treatment decisions and your options? 

Dr. Kelly Shanahan: Yeah, thank you Fumiko. Thank you, number one, for inviting me to contribute to this issue and for your kind words about my piece. I come from a place of privilege. I was a physician when I was diagnosed, but both with early stage and metastatic cancer. Yet I still suffered significant financial impacts. When I was early stage, I had the option, obviously, of either a lumpectomy with subsequent radiation therapy or a mastectomy. Well, I live at Lake Tahoe where we have zero oncology services at my end of the lake. And so for me to have a lumpectomy, I would have to drive 45 minutes to an hour each way, five days a week for radiation therapy, for, at that time, five to seven weeks. We didn't have accelerated courses of radiation back in 2008. I had a then nine-year-old and I was in solo private practice. So if I had chosen radiation therapy, that would have been time away from my practice, loss of income, having to make sure my husband or somebody else could pick up my daughter. So I chose to have a mastectomy and that was my primary reason for choosing that type of surgery. 

Then five years later when I was diagnosed with metastatic breast cancer, again, no oncology services in my town, except for someone I was ironically subletting my office to one day a week who recommended combination IV chemo, hoping to get me closer to the starting line so I could perhaps live longer. My daughter at that time was in 10th grade, a sophomore in high school, and I would have done absolutely anything to try to make it to her high school graduation. So I did the chemo which included a taxane, which left me with permanent chemotherapy induced peripheral neuropathy. 

Now, it's a little challenging to be an OB/GYN with numb fingers because I know I wouldn't want somebody trying to catch my baby or wielding a very sharp scalpel over my anesthetized body who had trouble feeling their fingers. So I had to stop practicing medicine, which was a huge, huge impact. I will remain eternally grateful to the men I started in practice with way back in 1991 when I finished residency for insisting that I get a disability policy because that is the only reason that my family did not have to declare bankruptcy was the fact that I had a long term disability policy. But it still made a lot of impacts on things we chose to do. I remember I was diagnosed prior to the advent of CDK4/6 inhibitors and I was diagnosed early stage, prior to the advent of the Affordable Care Act, which was a whole other thing. But I remember thinking, "Oh, my gosh. If I have to go on a CDK4/6 inhibitor that's going to cost $15,000 a month, I'm going to have to pay a 20% co-pay." And that's a choice between putting that towards my daughter's college education. I would have chosen not to take that medication. Those are huge things, and that seems cheap. 

Now, I am currently on a medication that was approved a year ago that is $28,000 a month. Fortunately, I have Medicare due to disability. I'm still not quite old enough for Medicare, that covers my expenses. I met that $3,400 medication deductible within the first month of being on that medication. But that has eased the financial burden. I also chose to participate in a clinical trial last year when my cancer progressed. And I live in a ski resort town 200 miles away from a major academic medical center. So it was 200 miles each way to participate in this clinical trial. And again, I had the wherewithal to be able to put a hotel or an Airbnb on my credit card, to pay for the gas and then wait for reimbursement. Not everybody can do that. We wonder why we can't accrue to clinical trials. We wonder why we don't have the diversity that we want. Well, these sorts of financial issues are part of the reason.

Dr. Fumiko Chino: Thank you so much for that overview of what you've had to deal with during the course of your disease treatment and that realization that, 'oh, this is with privilege' that I know what struck a chord with me as a cancer caregiver. 

I was brought into the field of financial toxicity as being the primary caregiver of my husband. He was diagnosed with cancer, again before the Affordable Care Act, and we had these caps on his health insurance payouts. And so we ran up against his lifetime payout cap and essentially had to pay everything out of pocket after that. And even just for people with long disease courses or who were treated before the Affordable Care Act, they've seen a huge sea change in terms of financial toxicity. But sadly, the Affordable Care Act hasn't made actual cancer care necessarily more affordable as we continue to produce more effective treatments, but they come at these great expenses. And I think we are now at, I would say a liminal point where we're at accelerating drug discovery and also accelerating costs. 

One of the reviews in this special issue focuses on the social and legal needs. Things like housing or food insecurity, transportation barriers, unemployment and psychosocial needs. They have a bidirectional impact on financial toxicity. And Dr. Hussaini and his team really put together a nice overview on this topic for the issue. Kelly, I know you've already spoken a little bit about this, about the transportation barriers, about the difficulties being unemployed. Again, coming from that position of privilege, can you talk about how hard it's been to even just navigate the healthcare system even with your incredible knowledge base as a physician expanding on what was hard for you, if it might have been harder for other people within the larger community of people with metastatic disease?

Dr. Kelly Shanahan: Yeah, I mean, I'm a physician and I know the healthcare system and I had a hard time figuring things out. And some of this, I realize now, when I was a practicing physician, I didn't know what things cost because what things cost depends on what your insurance is. And that's true of the cost of an office visit, of a procedure and of medications. That was challenging as a patient knowing who to call to find out to get a patient assistance program. And then when you have Medicare, again, whether it's because of age or because of disability, you hear all these things about, "Call company X if you need financial support for our great drug," but that's not accessible if you have a federally funded insurance. So I think that was really challenging to figure that out. 

Fortunately, a great clinical pharmacist at UCSF really helped me with that process. And I think that's something that we don't realize as patients is there are other resources. Our doctors don't know all the nuances of the financial aspects. If you are being treated at a larger academic medical center, there should be a financial navigator. But considering the fact that most people with cancer are treated in the community, and especially if you're treated in a private practice versus one that might be affiliated, let's say with a community hospital, they may not have an oncology social worker, they may not have a navigator. And I really wish there were more programs available like the one at Levine Cancer Institute that has a financial navigation program, a multidisciplinary program to help patients. There are a lot of resources available to patients.  

I am on the board of directors of METAvivor. Our primary focus is raising money for metastatic focused research. We fund research, but we also offer resources that we can connect people with on our website, connect them to places where patients can get financial help. There is a fabulous organization, the Lazarex Foundation, which used to provide financial support to help people do a clinical trial, support for housing, support for transportation. And I know their funds are limited and that has sort of gone by the wayside, and that's really unfortunate because we want more people to participate in trials.  

And I think we have to move away from this, "Oh, yeah. We, the pharmaceutical industry, the sponsor of the clinical trial. We'll reimburse you."  Number one, they do not tell you that upfront. I knew that. I know that from the relationships I have with some people in the FDA. I know that that is allowed. So I specifically asked about that. But most patients don't know that. And I think any patients that might listen to this, if you're contemplating a clinical trial, upfront say, "I know that reimbursement for my travel related expenses and trial related expenses are allowable under FDA guidance. So how are we going to do that?" 

But I also think that this needs to be not retrospective, not a reimbursement, but for a lot of people it needs to be an upfront payment. Even things like to cover the Uber for them to get from where they live on one side of a major city to the cancer center on the other side. So we need to do that. And recently, at the San Antonio Breast Cancer Symposium, in a session for advocates with the FDA, I asked that question: Does the FDA preclude payments before the fact? Do you consider that inducement? And the answer was "No". There's no rule that says you can't do that. So again, we as patients need to be educated that there are resources available to us and don't take 'no' for an answer.  

Dr. Fumiko Chino: I love all that information. And I know certainly when I was a caregiver, when my husband was sick, we had evaluated all the clinical trial options and found one that was potentially an option for him in California. But the travel expenses were too great for us to overcome the upfront cost because at that time he was out of work, I was out of work, we were both out of work, we had no income coming in. And so those travel expense barriers were one of the main reasons why it was a non-starter to even think about the clinical trial enrollment for him. It's just depressing to think that that could have made a difference. But I know that clinical trials work. That's how we discover new treatments.

Dr. Kelly Shanahan: Yeah, and the more people that participate and the more diverse a population– If the only people doing clinical trials are old white women, then how do we know it's going to work for young black women and men or other ethnic groups? We need diversity so that we know how the drugs work, what side effects they have in diverse populations.

Dr. Fumiko Chino: Now, Ryan, I want to pull you into this. What have you found can be helpful to help assist patients who may be struggling with their social or legal needs or even just having difficulties making ends meet?

Dr. Ryan Nipp: Yeah, Kelly, I had worked in the past too with Lazarex Foundation and found them to be phenomenal and the opportunity to get more patients onto clinical trials was a no-brainer and such a valuable resource.  

So I think for this question, I do love this question, I think it depends as Kelly was kind of hinting at too. It depends on insurance, depends on the person, depends on the specific needs. But again in thinking about this, I think there's some growing evidence supporting things like financial navigation. Like you said Kelly, not every place has it. I'm actually very fortunate now at our cancer center in Oklahoma, we do have financial navigators and I always thought that was extremely forward thinking for them. We also have great social work assistance, knowing that that's a limited resource, but we have amazing social workers which I often sometimes get their expertise and help for this. There's some research out there showing that financial assistance with things like travel, lodging and co-pays could be beneficial for our patients. Again, trying to find those resources and is it sustainable? That is a tough question. 

We also have an article in this special series focused on financial assistance programs by Dr. Raghavan which is phenomenal. It's an editorial on this topic I would encourage people to look into when this comes out. I've also just lastly admired recent work that shows that there's an intervention that, I think, I'm not quite remembering where it was tested, but it's a financial hardship screening intervention where they were asking people about financial hardship and then over time were able to find that by just asking and then bringing in whatever resources might be available, this could address the issue of financial toxicity in that study and it was an extremely impressive compelling outcome with that kind of a model. What I think is the future is that we need to continue to see those types of models put into routine practice and how can we actually implement those in our day to day practice. But that to me was very promising when that came out in recent years.

Dr. Fumiko Chino: Absolutely. I think you're referring to Dr. Blinder's piece in JCO from last year.

Dr. Ryan Nipp: Yes.

Dr. Fumiko Chino: Dr. Blinder was one of my amazing colleagues at MSK before I transitioned down to Texas. 

Dr. Kelly Shanahan: Yeah, and Dr. Blinder is working on a new proposal. I am one of the advocates on that proposal again about the financial screening. And again, just even asking the question can make a difference. 

Dr. Ryan Nipp: Yup.

Dr. Fumiko Chino: Absolutely. I know you both kind of pointed out that there are limited resources, but this idea that it's sort of depressing that someone who might be in need will not actually get the assistance from their physician or their physician team or their cancer center, but they'll have to reach out to other patients, and I'm so glad that that information is being shared. But it seems like we could be doing better. More orderly assistance, more navigation, more direct help to patients who actually need it in the way that they need it because it's not one size fits all.  

Now, switching topics just a little bit, I had the pleasure of working with Dr. Littman, who is a resident at NYU, on a review in this issue about the role of cost conversations to decrease financial toxicity. And I know from my own prior research that only about 5% of oncologists say that they've had any training on discussing costs and that cost conversations seem to be rarely happening in clinical practice. Certainly from my own perspective as a cancer caregiver, I can say that cost conversations, despite incredible financial toxicity from my husband's treatment, were just not being had. Now, Kelly, have you ever had a discussion about cost with your treating team?

Dr. Kelly Shanahan: I have never had my treating team ever bring up costs. Now, as I mentioned before, when at one point I was contemplating going on a CDK4/6 inhibitor, I did say, "If I need to go on a CDK4/6 inhibitor now with this huge co-pay, I'm not going to do it." But I didn't get that, "Oh, here's some resources that we can have." I was sort of like, "We'll figure that out. You don't need it right now." And fortunately, I did not need it until I was able to get on an assistance program and then had Medicare. So it wasn't prohibitively expensive. Although I did fall into that catastrophic donut hole one year. That was not fun. 

But I think this is something that we patients talk about frequently. People, they're worrying about paying their bills, about paying their medical bills, do they pay their hospital bill or their doctor's bill or do they buy food? Do they pay their utility bill or do they pay the co-pay for their medication? And we should not, in the supposedly richest country in the world, be having to have these conversations. We share resources about people who have unused medications. If you have progression of your cancer and you have to switch medications, but you still have two months of a three-month supply, how can that be legally distributed to other patients? And there are organizations that can do that. We try to let people know about that. But yeah, patients frequently talk about this. It's so heartbreaking when someone has to do a GoFundMe to pay for their medical care or to pay for their funeral or the funeral of a loved one. 

Dr. Fumiko Chino: Yeah. My standing joke, which is not really a joke, it's more of a 'ha-ha sob', is that GoFundMe is actually the US's largest cancer insurance provider, which is fundamentally very depressing. And I think one of the points that you pointed out about just even just eliminating waste- so if I have a drug that I'm no longer using, how do I donate that to the next needy person? When my husband died from cancer, we had a supply of Zofran that we had paid very dearly for. He was past his pharmaceutical benefit. We were paying $35 a pill. This is when Zofran ondansetron was still on patent. And I was like, these pills are very expensive. And I turned them over, actually, to my mom who's a physician to distribute in her clinic because I wanted people to not have uncontrolled nausea. I know now, working at world leading cancer centers that there's no actual way of doing that here, but a community cancer center can do it. I think we just- trying to get more efficient all across the board is so important. 

Now, Ryan, how do you broach the topic of affordability with your patients? Do you try to preemptively discuss costs or really just wait for when there seems to be a problem with affordability?

Dr. Ryan Nipp: Yeah, I knew this was coming up. I think it's a bit of a touchy topic at times because you don't want to presume and like to bring it up. In some ways, there's this option of, at least in Oklahoma now, where people are traveling a long distance often to see us here in Oklahoma City. And so sometimes you can just start to broach the idea of like how much trouble was it to get here? Do you think you'll be able to make these trips every two weeks? That two hour drive, how's that going to be? But in general, I think I am talking more in recent years about the issue of financial toxicity. I agree with Kelly. It's rare when it does come up, but in recent years it's coming up slightly more often than maybe zero like it used to be. And I think, for one, it's because patients are bringing it up more. I think they're feeling more empowered to talk about it. It's more you're able to have that opening to bring this up to me. I would welcome the opportunity. Of course, I'm passionate about this topic. And then second, I think there's increasing awareness of the available resources. There actually are things that are being studied and there may be options. Whereas in the past, perhaps we were totally just at a loss, like if our patients would bring it up, we would feel awful for them, but there wasn't a lot we could offer. And again, in Oklahoma now, we have phenomenal social work that is available to us at all times, as well as that financial navigation as I was hinting at before. 

But also, Kelly, you mentioned this before and thinking about this, the fact that we have clinical pharmacists in clinic with us that are just sitting right next to us in clinic has been a priceless resource for me. I found their insights and expertise to be very helpful in finding ways to address financial toxicity. Are there other ways that we can help this person? They brought up that this new anticoagulation pill that they're getting is super expensive. What can we do to help them? Things like that. They're with me. They're willing to look into are there other things that we could be doing again? Also at University of Oklahoma, when I got here, actually, they were already doing some work on this idea of financial toxicity screening, meaning: Can we preemptively be asking patients about their financial hardship or financial needs? And then when things are identified, again, we have cancer center navigators who are available to us for those positive screens to help put people on whatever paths we have available to address those things.

Again, in our special series that we have coming out in JCO Oncology Practice, we have a few articles that also talk about this idea of utilizing screening tools and questionnaires to identify patients who may be at risk for financial toxicity. And then some of the work that's growing with regards to once you identify somebody who screened positive, what to do with that positive financial toxicity screen.

Dr. Kelly Shanahan: And you know, you bring up that idea of bias and stigma, and I think that can be easily eliminated by asking every single patient. Doesn't matter whether somebody rides the bus in or they roll up in a Rolls Royce. If we ask every single person: Are you having any financial hardships related to your cancer treatments? Then we normalize it, we remove that stigma, and then we can help more people.

Dr. Fumiko Chino: And I've definitely seen that, I'm sure, from your own practice as an OB/GYN, like STI screening, we ask every single person about STI screening and it's not targeted towards youth. We ask everyone in a cancer center for falls. Have you had a fall? That's just part of our routine screening. So I feel like integrating one or two questions about financial toxicity could be a real avenue for helping identify financial toxicity earlier. Hopefully, intervening before it gets to the point at which it's end stage of financial toxicity, so to speak, when people are not showing up for their appointments anymore at all. 

Now, we're heading towards the final part of our conversation today. I just wanted to give a little bit of space for open topic conversation. Is there anything that you feel like we really just should address for the future of financial toxicity? Whose voices are here, whose aren't? How do we make actual meaningful change to stop describing the problem but actually start to fix the problem? 

Dr. Kelly Shanahan: Well, I certainly think the payers need to be pulled into the mix because they're the ones that are leading to denials. They are the ones that are requiring prior authorization for antiemetics for highly emetogenic chemotherapy. So I think they need to be pulled into the mix. I think our physicians, our care team, need to be pulled into the mix as well as the patients and caregivers.

Dr. Fumiko Chino: Ryan, anyone that you want to have more involved in this conversation, any way to expand it?

Dr. Ryan Nipp: You mentioned it there at the end, Kelly, is the caregiver. I think we haven't done a lot of work looking at that. Again, back to the research part and describing the issue, we haven't really done a lot looking at the caregiver side. The other piece that I think as we were putting together this special series was the international global perspectives that we did have a little bit of trouble trying to find. It's just different across different geographic and global areas so that's something else that should be studied more. We kind of hinted at it today, this idea of pharmacists being involved. We haven't seen a lot of work in that space. The other thing to think about is, at least in the places where I've practiced the APPs or the individuals seeing our patients a lot of the time and also empowering them to bring this up and have some tools and just bringing them into the research realm and to future intervention development. 

The last thing I'll say, because we have brought it up a few times today, but I do think a wide open area is what do we do about clinical trials and the affordability of being on a clinical trial and making that more available or able for patients to be going onto clinical trials. I think that's an interesting space to continue to research. 

Dr. Kelly Shanahan: Yeah. Step number one, every single patient with advanced cancer should be offered a clinical trial. Again, no assumption should be made. And number two, we need to make it so that everyone can afford to, time wise, money wise, to participate in clinical trials. It was a great privilege. I am so grateful that I was able to do a clinical trial and I look forward to doing others in the future.

Dr. Fumiko Chino: Absolutely. I really think that this idea of travel burden is such a huge barrier for many of our patients for getting even standard of care treatments, but much less enrolling on a clinical trial. And every piece of data that I've ever seen shows that you will actually get more enrollment and a more diverse patient population on your clinical trials if you just open the clinical trial closer to where the patients are actually living and getting their cancer treatment. So decentralized trials or trials within community practices, trials within the NCORP or the NCI's Community Cancer Center, or even again within regional centers affiliated with academic medical centers. These are always, I feel like, decreasing that travel burden. 

Dr. Kelly Shanahan: And I just thought of one really simple way to decrease financial burden on patients. Just going for tests, imaging, doctor's visits - a patient should never have to pay for parking.

Dr. Fumiko Chino: Now, you're beating a drum that I can dance to. The parking ridiculousness. It led to, honestly, I think, at this point probably my most read research topic, which was just evaluating parking costs. And it is such a stupid thing to study. The fact that parking could be a barrier to receiving optimal medical care is so frustrating, infuriating if nothing else. And yet it is so common. I saw it in my practice in New York where they just couldn't afford to travel into Manhattan for anything that had to be done on the main center. It's a ridiculous barrier.

Dr. Kelly Shanahan: $5 an hour to park at UCSF to go see your doctor, get imaging, or get labs.

Dr. Fumiko Chino: Absolutely. And the funny thing is that the travel and the parking then must be balanced with the time toxicity, which is consolidating all appointments down could at least decrease your parking costs. But then you're literally at the cancer center the entire day and then you need to buy your lunch at the cancer center or you missed out on another day of work potentially. And so really thinking about this from a very patient centered framework is so essential to just move forward. And it's one of the reasons why I've been so honored and privileged to collaborate with patient advocates like Dr. Shanahan. 

Well, I will wrap it up. I want to thank you so much for having such a robust conversation today about such an important topic. I can't really think of a better focus for our first podcast issue. I really want to thank both of our guests and also our listeners for your time today. You can find links to the papers that we discussed in the transcript of this episode. And if you value the insights you hear on the JCO OP: Put into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. As a new podcast, we really do depend on you, the listeners, to spread the word that we're out there and we'll hope that you join us next month for our second episode. Until then, please stay safe and warm in 2025.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Kelly Shanahan:
Consulting or Advisory Role: Pfizer, SeaGen, Sermonix Pharmaceuticals, Jaguar Health/Napo pharmaceuticals

Dr. Pennell talks to co-author Dr. Maria Silveira about why it can be so difficult for oncologists to refuse chemotherapy treatment to patients near death.

This podcast is introducing JOP's new social media editor, Dr. Deanna Attai.

Dr. Horvitz and his co-authors found that signals about patterns of queries in search logs can predict the future appearance of queries that are highly suggestive of a diagnosis of pancreatic adenocarcinoma.

Author Marge Good discusses the results from this project which demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The ASCO Clinical Trial Workload Assessment Tool was shown to be feasible and useable in diverse community-based research settings.

The author discusses survivorship care, one of the most challenging problems oncologists face today and in the near future. The core curriculum and competencies outline in his manuscript are fundamental to the relatively new field of survivorship care, and provide the framework necessary to generate appropriate referrals depending on local practices and expertise

Journal of Oncology Practice Associate Editor Apar Ganti talks with Consultant Editor Nathan Pennell about what readers can expect to see in the pages of JOP starting in 2016.

A strong brand gives people confidence as they gain awareness of it and come to understand and experience its benefits. The author talks about his suggestion for three steps toward building a better brand for palliative care.

The author shares his experience as an expert witness in an oncology Medicare fraud case in Michigan. 

Dr. Anthony Back, MD, discusses the sobering question raised by McFarland et al.  The study findings—that inpatient oncology rotations are associated with decreases in interest, empathy, and resilience—suggest that inpatient oncology units have managed to compress into a month a process of hardening previously thought to require years.

The authors discuss key factors to consider that may influence decisions to participate in the Oncology Care Model, by presenting comparable payment reform efforts outside of oncology.

Dr. Pennell and Dr. James Hammock discuss the provision of oncologic services by Project Access safety net care coordination programs.

NATHAN PENNELL: Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JCO OP. I have no conflicts of interest related to this podcast. And a complete list of disclosures is available at the end of the podcast.

Today, I'd like to talk a little bit about the complexities of providing cancer care for patients who are uninsured or underinsured, which is a relatively large percentage of patients in the US.

How do patients without insurance receive cancer care? One way is through community programs, including a program called Project Access, a care coordination program connecting patients to specialty medical care at no or reduced cost, including, in some instances, oncology care.

But how does it work? Who does it help? And how impactful are this and other programs designed to obtain cancer care for low-income, uninsured, and underserved patients? With me today to discuss this topic is Dr. Jamey Hammock, a resident in internal medicine at the University of Alabama Birmingham.

We'll be discussing the paper from he and his colleagues titled, Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs, which was published online July 31, 2020 in the JCO OP. Welcome, Jamey, and thank you for joining me on the podcast.

JAMEY HAMMOCK: Hey. Thank you, very excited to be here. I did want to say too that I do not have any conflicts of interest or disclosures for this particular study.

NATHAN PENNELL: Why don't we start out by talking a little bit about how big a problem it is for providing cancer care in uninsured and underinsured patients in the US.

JAMEY HAMMOCK: It's an enormous problem. If you look at previous studies, they've looked at patients who are underserved, underinsured, or even uninsured with cancer. And these patients actually typically present with later stage disease, they experience delays in treatment, and ultimately have worse overall survival compared to well-insured patients.

So just that alone tells you how big of a problem that this is. I think that when you look at cancer care for underinsured and uninsured, you have to break those things up. And you can't really talk about it without talking about the Affordable Care Act.

So let's take uninsured patients, for example. If you look at pre-Affordable Care Act and post-Affordable Care Act, there's a great study in 2017 that really broke down these two groups, pre and post. And what they found is with the Affordable Care Act, if you are uninsured across any income level and you lived in a Medicaid expansion state, the percentage of patients who were uninsured decreased from about 5% to 2 and 1/2%. So it really cut that percentage in half, which is pretty impressive.

And then if you look at low-income uninsured patients, because they broke that down in the study, the percentage actually dropped from around 10% to 3 and 1/2%. So It just shows you when you talk about absolute numbers and then those percentages, how many individuals are really affected that have a diagnosis of cancer and are uninsured. And it gives you a little bit of insight of what Medicaid expansion has done for that group.

And then I want to touch really quickly too on underinsured. So basically underinsured patients, they don't have the means to get the care that they need, even if they have insurance. That's important.

And patients with Medicaid, for example, they have insurance, but they have their own challenges. For example, there's been studies showing that they have longer wait times to see some specialists. It's harder to find a physician that takes patients with Medicaid.

Lastly, these providers are so few and far between that sometimes these patients are asked to drive very long distances to get the care they need. And you're already talking about a disadvantaged patient population who may not have the means to drive an hour away to get to their visit.

NATHAN PENNELL: That sounds very challenging situation, even for people who technically have health insurance, and still don't necessarily have what they need to access care the way it should be given.

Can you tell us a little bit about Project Access? I have to admit, I had never heard of that before I read this paper. And it was a fascinating program that something like this exists. Can you tell us a little bit about it?

JAMEY HAMMOCK: Absolutely. So Project Access, first off, they do great work. It's a nonprofit organization that really, really works hard to try to get patients who are underinsured and uninsured subspecialty care.

So I want to talk real briefly about the history first because I think it helps you understand why Project Access came to be. I think we need primary care pretty well in the US for patients who are underinsured and uninsured. We have things called community health centers, which are federal qualified health centers funded by the government.

And they really do a good job providing primary care for patients who cannot get it elsewhere. The problem is that a lot of these patients ultimately will end up meaning a subspecialist. And there does not exist a community health center for subspecialty care that's funded by the government the way that community health centers are.

One thing to address this was Medicaid expansion. Medicaid expansion was supposed to increase the amount of patients who got insurance and thus wouldn't be able to obtain the subspecialty care that they need.

But we've already talked about some of the shortcomings of Medicaid expansion, including not all states have done that, decided to expand unfortunately. And if you're an undocumented immigrant, unfortunately, you don't have access many times to government programs.

So it doesn't do anything for those populations. There's been some other strategies, Dr. Pennell, to try to address subspecialty care in these populations, things like telehealth, and which you would need the technology, things like subspecialists actually coming to community health centers, let's say, every other Friday to see a patient who needs a cardiologist or an oncologist.

But the problem with that is it's a little sporadic, it's inconsistent. And sometimes these patients can't be that flexible and come in the only day that the specialist is going to be there. And so really, here enters Project Access to say, you know what, let us negotiate-- pre-negotiate with subspecialists in the community that surround these community health centers and find subspecialists that agree to see x amount of patients a year.

And when it comes time to refer a patient to a specialist, you contact us, and the work has been done. And so they sort of broker, if you will, or negotiate between some specialists in primary care. And they do a lot of the groundwork that it takes to get these patients the subspecialty care they need to get the results of the subspecialty visit back to the primary care. They do all of that legwork. And so they really are an incredible, incredible service.

I do want to mention, they're more of a local solution. So Project Access Birmingham, for example, it serves the residents of Jefferson County. It's not meant to be a statewide solution. They're very good at serving the patients who are near, who are in the county.

And in fact, a lot of them have requirements that you be a resident of the county that they operate in. But they do a wonderful job getting these patients the subspecialty care that they need.

NATHAN PENNELL: Well, I have more questions about Project Access. But I think you're going to answer some of them when we start to talk about your paper. So why don't you just start off by talking us a little bit about, what was the purpose of the project that you did and how did you design your quality project.

JAMEY HAMMOCK: This project started out as a genuine question I had working as an intern in internal medicine. I would see patients come into our hospital who were uninsured who had a malignancy or cancer. And I would just ask, where do these patients get their care. How are they suppose to get outpatient clinic follow-up?

So that's when I learned about Project Access locally here in Birmingham. And as you just mentioned, I had a ton of questions. So I actually went and met with Project Access and just asked them all of these questions.

How do you work? How is your funding? Who do you see? What specialties do you provide, et cetera, et cetera.

And I decided I wanted to really take an in-depth study and look at our Project Access here in Birmingham. When I began doing the literature review for that, I realized that there was not much out there in terms of this Project Access model. I was told that many other ones exist across the country, but there had not been a lot done in the medical literature describing these places and the wonderful work that they do. And so at that point, I began to zoom out a little bit and look at all of the Project Access centers that exist in the country.

NATHAN PENNELL: What did you find out when you started calling and checking in with all of the different Project Access programs?

JAMEY HAMMOCK: To kind of bring things back to home, I really was particularly interested in how these Project Access centers offer oncology care because oncology care is a little bit different than other subspecialties in terms of the resources needed to provide such care. And my interest was, how do programs who are nonprofit who are trying to work with underinsured/uninsured patients provide care that require so much resources. So that was really one of my objectives is to tailor my approach to oncology care, specifically, while also describing the programs in general.

And so what I found was that out of about 30 programs that I found, roughly 2/3 offered care medical oncologists. And then out of those 2/3, about 1/2 of those programs actually offered chemotherapy.

Fortunately, everyone offered radiographic studies, such as MRI, CT, PET scan. So they could at least assist in diagnosing or helping to diagnose suspicion for a malignancy. Obviously, that doesn't include a biopsy, but could at least sort get the ball rolling, if you will.

And then the other thing I discovered is, as I mentioned previously in the podcast, there was a lot of heterogeneity between the programs. So some programs offer transportation, some programs offered interpreter services, while others did not. Some programs required small co-pays. It seemed that everything was really tailored to their respective local community and what worked best for that community.

In terms of Medicaid expansion, which was sort of another thing we were looking at with this study, what we found is about 2/3 of the states that have not expanded Medicaid have a Project Access center. And if you compare that to states that have expanded, only about one third of those have Project Access centers.

And so our study suggests that the need for pro bono care is a little higher in Medicaid non-expansion states. And I think that that's intuitive. The percentage of uninsured patients with cancer in a non-expansion state is as high as 13%, depending on what their income is. And that's compared to about 2% to 3% in a state that's expanded Medicaid. So those are drastically different numbers and drastically different needs for patients, depending on if they reside in a state that has expanded Medicaid.

NATHAN PENNELL: But it seems as though the difference between areas that had programs that offered cancer care and those that didn't probably revolve around whether they're able to find practitioners who are willing to provide those services. And it looks like you did some investigating of programs that did and did not offer cancer care. So what were the differences between those?

JAMEY HAMMOCK: The next step of my project was to interview those program coordinators of the centers who were not able to offer medical oncology care. And three common themes emerged as I talked to these program directors.

The first of those themes was cost. And I think that that's intuitive. And it did not surprise me. Medical care is expensive. Oncology care is expensive. And these programs, they're mostly nonprofit and rely on donations and such.

And so the first barrier to offering this is cost. The patient see the medical oncologist, and they prescribe chemotherapy, someone has to pay for that chemotherapy.

And a lot of Project Access centers were not prepared to do that. One in particular I spoke with, they had actually considered it. And when they ran the numbers, it would account for over half of their annual budget. So it just was not feasible.

The second barrier that emerged while I was talking to these program directors was the concept of continuity and a longitudinal commitment. So for example, if I'm a medical oncologist and I decide that I want to take part in this and donate some of my services, and I see a patient that has a new diagnosis of cancer, and we treat the cancer, what happens if they relapse or what happens in five years that they need a medical oncologist again?

And I don't think many oncologists were comfortable committing to a situation that had no clear end date. That's in contrast to a patient that has COPD and the primary care physician is referring them to a pulmonologist to get recommendations on maintenance inhalers and what might work best for this patient. That's more of a one and done visit.

The third area barrier emerged as I talked to these patients was the concept of multiple physician buy-in. And so, as you're aware, many patients that have a cancer may require care from multiple subspecialties, whether that be surgical oncology, medical oncology, radiology, diagnostic radiology, and even palliative care. And so it really is a disservice to a patient if you can offer them not the full scope of oncological care that they need. A lot of Project Access centers were not comfortable providing some of the care without providing all of the care, if that makes sense.

NATHAN PENNELL: I mean, all of those make perfect sense. I mean, although in some ways they relate partly back to the first issue, which is that things cost more if they take a long time and have to continue indefinitely over time.

So I'm curious, for the places that did offer chemotherapy, and actually even though it was a relatively small percentage, it was not trivial, chemotherapy is extremely expensive. As you mentioned, some of them looked at it and decided it was going to be something like half of their revenue for the year would be taken and providing this. How did those that covered chemo actually cover the cost of that?

JAMEY HAMMOCK: That's a great question. I had the same question. And so what we found is that most of the programs who were able to offer medical oncology and then services, and then taking the next step to offer chemotherapy, they were affiliated with very large hospital systems in the area.

So I'll give you an example. Here in Birmingham, our Project Access center works with UAB. And they're able to offer these services because UAB takes the baton, if you will, and carries the care forward, offers that chemotherapy that is needed. So it's done through large affiliated hospital systems. If that does not exist, or if that relationship is not there, then what my study has shown is that it's not feasible.

NATHAN PENNELL: Right. That makes sense. I mean, individual oncology offices that order their own chemotherapy could probably never afford to just donate that, whereas large systems have other ways to do that. And of course, the large nonprofits also have to give back to the community and may just consider that part of their community service.

What's the next step to extend this? I guess, the larger question is, it'd be great if perhaps everyone had health insurance. But until that happens, what steps can be taken to provide something like this more broadly?

JAMEY HAMMOCK: Yeah, so that is exactly what I was thinking. Medicare for all is the answer. And ultimately I think we need a centralized universal health insurance policy. But that's not the topic of this podcast.

So until then, Project Access is stepping into the gap and doing this great work. And I really wanted them to be recognized just as a organization, broadly speaking, and then on an individual basis. They are on the ground doing the hard work, making the phone calls, making the partnerships, raising the money. They're really doing incredible, incredible work for people out there who have no other options.

It's not enough. As I mentioned earlier, these are local solutions to statewide issues. If you look at Alabama, it's a non-expansion state, unfortunately. The patients in Jefferson County here where Birmingham is, they benefit from Public Access, but the patients in Shelby County might not. So it's a statewide issue for the states that don't have Medicaid expansion, and then even a small population in the states that do.

One thing that we can do is we can look at the examples that have been set by Project Access centers who have partnered with these hospitals and collaborate and say, listen, we're a Project Access center that has not had any luck. Please share with us how you were successful in providing oncology care to your patients.

My hope is that this project provides a list where collaboration can begin. And these places can learn from each other.

NATHAN PENNELL: Well, I think that this is fantastic. And I'm really happy that we're going to be able to highlight Project Access and your manuscript so more people are aware of this and hopefully can start shining lights on their own local Project Access programs.

JAMEY HAMMOCK: Right, right.

NATHAN PENNELL: Well, Jamey, thank you so much for joining me on the podcast today.

JAMEY HAMMOCK: Thank you for having me. I thoroughly enjoyed it and love talking about Project Access and access to care. And I really appreciate it.

NATHAN PENNELL: Until next time, I also want to thank our listeners for checking in on this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts, or wherever you listen.

While you're there, be sure to subscribe so you never missed an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper is available online at ascohubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

PRESENTER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care. And is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions.

The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org.

This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

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