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3 Questions on…

Answers straight from the experts on the latest news and topics in oncology

Wednesday, March 20, 2019

With Ronald R. Barkley, MS, JD, President of the Cancer Center Business Development Group

By Sarah DiGiulio

Few disagree that high health care costs are a growing problem and solutions need to be developed. One solution is a system management and triage pathway protocol. The goal of these protocols is to reduce costs and deliver high-value care by better managing patient symptoms and side effects of treatment to reduce unwarranted emergency room visits.

A recent study examined the cost-savings potential of using such a strategy. Researchers identified likely emergency room visits that were avoided (as documented in the triage program) at two practices participating in the Center for Medicare & Medicaid Innovation's (CCMI) Oncology Care Model program over a 6-month period. They calculated an estimated cost savings based on the average emergency room and hospitalization costs for such events (J Oncol Pract2019;15(2):e91-e97).

The results revealed 222 emergency room visits were avoided—an annual cost savings of $3.85 million between the two practices.

"In addition to improved patient care and satisfaction, [this data provides] further evidence that cancer care costs can be reduced through a routine system of symptoms management and nurse triage of symptoms," noted study co-author Ronald R. Barkley, MS, JD, President of the Cancer Center Business Development Group, a company that advises oncology practices in transitioning to and implementing value-based care systems.

The researchers noted the study's limitations. For instance, it is impossible to know with certainty—based on the predictive design of the study—whether or not the emergency room non-events identified as being avoided because of the symptom triage program would have actually turned into emergency room visits or hospitalizations without the program.

The study authors also noted the time period used to look at such events was limited to 6 months, and the figures they reached do not include operating expenses incurred by the practices to provide the symptom management and triage program services, nor did the study attempt to identify any amounts of alternate payment model reimbursements earned by the practices associated with the cost savings achieved for payers. Follow-up research will analyze data from a larger number of practices and factor in operating cost data, Barkley said.

Here's what else he said about the significance of these findings and the potential of such symptom triage pathways.

1. What is a symptom management and triage pathways program and how do they help save money?

"A software service documents incoming patient calls and diverts high-acuity calls to a nurse call center for intervention. The system allows providers to manage a high volume of patient inquiries. Without it, a high volume of patient calls can slip through the cracks."

2. Why is value-based care and implementing strategies that save important in cancer care?

"There is heightened public awareness and government scrutiny with regard to the high costs of health care. It is well-known and documented that health care services are provided that are unwarranted, unnecessary, and could be avoided. This is true in oncology care.

"So, if we can avoid unnecessary services through care management and cost consciousness, why shouldn't we do so?

"Reduced units of service equal reduced costs (claims) to the system. Why is reducing emergency room events and associated hospitalizations an important part of overall cost-saving strategies (in addition to looking at other factors, like drug costs, etc.)? One of the three primary sources of reduced services and costs in oncology is in precluding unwarranted emergency room trips and subsequent emergency room-related hospitalizations.

"Cancer patients undergoing active treatment (chemo in particular) experience dizziness, nausea, vomiting, and dehydration. When a patient is at home and experiences these side effects, the natural tendency is to call 9-1-1 or run to the ER. However, if the patient and/or caregiver had an alternative, such as a nurse call service to walk them through their symptoms and see them at home, or an in-office physician instead, most of the emergency room trips could be precluded.

"Avoid an emergency room trip and emergency room-related hospitalization and you just precluded generating the associated costs.

"Note that chemo patient emergency room visits result in hospitalization a high percent of the time (50-75% in some instances). Emergency room staff are trained in trauma, not cancer care, so the tendency is to get the cancer patient out of the emergency room and into a bed to free up space for the trauma cases."

3. What is the key takeaway message from this research?

"Reduce costs to health care systems and payers through symptom management. However, there are operating costs to the provider associated with providing such enhanced care. Absent an innovative or alternative payment model to incentivize and compensate for the increased operating costs to providers and costs reduced (savings achieved for the payer), the only winner is the bottom line of the payer.

"Examples of [alternative payment models] in oncology that financially reward a provider for the extra effort are the CMMI Oncology Care Model program, Anthem Cancer Care Quality Program, and Aetna oncology medical home—all with economic features built in to incentivize providers to preclude unwarranted services and costs."

Tuesday, March 5, 2019

With Delphine Lee, MD, PhD, Chief of the Division of Dermatology at Harbor-UCLA Medical Center

By Sarah DiGiulio

Some research has found that being obese may have a protective effect when it comes to risk of non-melanoma skin cancers. A large new study, however, finds that those previous conclusions may be misleading.

The new data, published online ahead of print in Cancer, shows that when looking at everyone, those who are obese do tend to get skin cancer less often than those who aren't (2018; https://doi.org/10.1002/cncr.31810). But when you consider rates of sun exposure, that protective effect disappears, noted Delphine Lee, MD, PhD, Chief of the Division of Dermatology at Harbor-UCLA Medical Center, in an interview with Oncology Times.

"People who are obese do have less sun exposure than those who are normal weight," Lee said, citing a 2013 study (Cancer Epidemiol Biomarkers Prev 2013:(12):2412-2415). "However, when correcting for sun exposure and age, the 'protective effect from obesity' decreases with increasing sun exposure and with age."

The new research analyzed data that had been collected for 71,645 postmenopausal women, of whom 13,351 developed a non-melanoma skin cancer. Though some previous studies have considered the role of sun exposure, this dataset included more detailed information about sun exposure and time outside, and analyzed its interaction with body size (rather than just as another covariate).

With increasing age and sun exposure, the risk for skin cancer increases—"and interestingly, increases the risk more so and more exaggeratedly in an obese person compared with a normal person," Lee noted. Here's what else she said about the research.

1. What led you and your colleagues to do this research now?

"The literature actually pointed to the fact that perhaps obesity (measured by BMI) seems to be protective against non-melanoma skin cancers—meaning that the higher the BMI, the less of a risk of skin cancer. And we thought that was a little odd.

"People often suggest it's because people who are obese may cover up or they may not be participating in as many outdoor activities.

"We decided to look at the Women's Health Initiative, which is a very rich database with three clinical trials and one observational study of women who kept answering questions about their health. These women had been answering these questions since the 1990s, so a lot of data had been collected about them.

"And because the investigators who started that study were so careful and comprehensive in collecting so much different information, it allowed us to tap large numbers to really address this question in a very thorough way. We have information on the geographic location of the women, the UV watts exposure, and a few other measures of sun exposure, as well as some surveys that had been sent to the women asking about how much time they spent outdoors at different times in their lives."

2. So why did your data yield different conclusions than other studies that had also looked at sun exposure, obesity, and skin cancer risk?

"Other studies have investigated the association of obesity on non-melanoma skin cancer risk; some have even included sun exposure in multivariate analyses, controlling for a potential confounding effect of sun exposure. And some authors have concluded that the finding of increased weight inversely proportional to non-melanoma skin cancer risk may be due to lower sun exposure in overweight and obese people in univariate analyses (this was by Tang who also studied this population) (Cancer Epidemiol Biomarkers Prev 2013:(12):2412-2415).

"However, we explored this issue at greater depth. We estimated and tested the effect of increased weight along with two additional significant factors: age and sun exposure, and found a more complex interaction that allows one to see the effects of each of these in relation to each other on the risk of developing skin cancer.

"For example, in older age groups and those who have had increased sun exposure, the inverse relationship of increased weight is markedly less dramatic. By examining the role of sun exposure, one of the key risk factors along with age, we were able to discern that the association of obesity and less skin cancer is not due to less sun.

"If you just look at the people who are obese, the risk of getting non-melanoma skin cancer—if they've been having a high amount of sun exposure, as well as having spent a lot of time in the sun—they have a much higher risk compared to an obese person who has not been in the sun. And in some instances, [they] also have a higher risk compared to a person with a more normal BMI and less time in the sun."

3. What's the most important takeaway message about this research for cancer care providers and for the public?

"It's a matter of educating the public about prevention. A healthy lifestyle, including managing obesity, is important for many other factors. This study sends a public health message to protect from the sun using sun avoidance (such as trying to stay in the shade or avoiding being outside between the strongest times of sun exposure), covering up, and wearing sunscreen. All of those things will decrease your amount of UV exposure.

"Another important message is that people who are obese can, in some instances, have the same amount of risk or an even higher risk of developing non-melanoma skin cancer if they spend time in the sun. The message to those people is that you're not protected."

Wednesday, February 20, 2019

With Peter D. Beitsch, MD, of Medical City Dallas Hospital

By Sarah DiGiulio

Guidelines exist for identifying patients who should undergo testing to determine if they have a genetic mutation (or variant) that increases their risk for developing breast cancer. But those guidelines were developed at a time when BRCA1/2 mutations were the most widely studied breast cancer susceptibility mutations and others were not as well known.

The landscape has changed, explained Peter D. Beitsch, MD, a breast cancer surgeon at Medical City Dallas Hospital and Research Director for TME/Breast Care Network. So he and his colleagues examined whether current guidelines adequately identify individuals with other genetic mutations (besides BRCA1/2) associated with breast cancer risk who should undergo testing. The results, published online ahead of print in the Journal of Clinical Oncology, showed that current guidelines come up short (2018; doi:10.1200/JCO.18.01631).

Investigators from across the country identified new and previously diagnosed breast cancer patients to undergo genetic testing with an 80-gene panel. A total of 959 patients underwent testing and had their data analyzed for the study. Approximately half met the National Comprehensive Cancer Network's 2017 genetic testing guidelines and the rest did not (and would not have otherwise met the criteria to be tested for a breast cancer susceptibility mutation). The researchers then compared the pathogenic variant rate between the two groups.

The data showed that nearly half of patients with breast cancer with a pathogenic or likely pathogenic variant with clinically actionable and/or management guidelines in development were missed following current guidelines.

"Guidelines restrict appropriate genetic testing and miss almost as many women as they identify with pathogenic variants," Beitsch said of the findings. He added that not all of the identified pathogenic variants (in the 80-gene panel) currently have management guidelines—but Beitsch suspects management protocols will catch up. "As we test more and learn more, I feel confident that we will learn how to manage these patients."

The bottom line is that all patients with breast cancer should have expanded genetic testing to optimize their treatment and identify family members with the same mutation who should be followed more closely, or even have prophylactic surgery to prevent them from getting cancer, Beitsch told Oncology Times.

Here's what else he said about the findings and why the research is so relevant now.

1. What led you and your team to revisit the genetic testing guidelines now and analyze them in this way?

"The guidelines have always seemed arbitrary—a 60-year-old woman with ER-negative cancer should be tested, but if she is 61 she should not. Or if she is 59, but has an ER-positive cancer, then she would not qualify for testing. None of this makes common sense.

"Guidelines were established approximately 20 years ago as a way to pick out women with approximately a 10 percent chance of having a BRCA1 or BRCA2 mutation. That was an era when testing was very labor-intensive and expensive.

"Approximately 5 years ago, a new technique, next-generation sequencing, made testing widely available and significantly cheaper. So, we undertook this study to see if guidelines really mattered—meaning did they really identify most patients with pathogenic variants (the new term for mutation)? They did not."

2. Why do you think there has been such a delay in updating the genetic testing guidelines to better incorporate all these new genetic variants associated with breast cancer?

"The guidelines have been periodically updated (usually yearly) since they were first developed. This, however, [has] just made them incredibly complicated and essentially unusable because of this complexity.

"You qualify for testing if you have breast cancer, have a sister with breast cancer before the age of 50, and a left-handed father with prostate cancer before 63. (I'm kidding [on that last part], but I'm not far off!)"

3. What is the bottom-line message that all practicing oncologists who treat breast cancer should know about these findings? And what should all cancer care providers know?

"[For oncologists who treat patients with breast cancer:] All breast cancer patients have an equal chance of harboring a pathogenic variant whether they meet genetic testing guidelines or not—so test ALL PATIENTS.

"[For other cancer care providers:] All breast cancer patients should have genetic testing with a large panel test to identify patients with pathogenic variants that may not only affect their treatment, but also may be harbored in their unaffected relatives (who should also be tested if the patient has a pathogenic variant)."

Tuesday, February 5, 2019

With Hoda Badr, PhD, Associate Professor in the Department of Medicine at Baylor College of Medicine in Houston

By Sarah DiGiulio

Head and neck cancer patients are typically asked to follow a fairly intense self-care regimen during and after undergoing radiation therapy. This can include drastically altering their diets to prevent malnutrition, sipping or spraying the mouth regularly with water to prevent dehydration, using salt-soda rinses 8-10 times a day (and/or saliva substitutes) to control xerostomia, practicing multiple daily repetitions of exercises to facilitate return to a normal swallowing, and engaging in intensive oral care routines to control mucositis and prevent dental carries, according to Hoda Badr, PhD, Associate Professor in the Department of Medicine at Baylor College of Medicine in Houston.

"Unfortunately, rates of non-adherence are high," Badr explained. And non-adherence can mean treatment interruptions, complications, and longer and more costly rehab.

So Badr and her colleagues developed a six-session, telephone-based intervention called Spouses coping with the Head And neck Radiation Experience (SHARE) (Cancer 2018; doi:10.1002/cncr.31906). The program teaches self-management, communication, and coping skills to patients with head and neck cancer and their spouses. In a pilot study that included 60 participants, the intervention led to better outcomes for these patients and their spouses compared with standard care (in this case, no intervention about self-management and coping).

Specifically, patients who received the intervention reported fewer physical symptom burdens than those who received standard care. Patients and spouses who received the intervention also reported lower levels of depressive symptoms than those who received standard care.

Here's what Badr told Oncology Times about the intervention, why it was developed, and the potential benefit it could have for patients with cancer.

1. Can you explain why you helped develop the SHARE intervention—and why spouses play such an important role in the program?

"Given the dosage of radiation required to successfully treat head and neck cancer tumors and the sensitivity of the location that is targeted, patients experience side effects (such as mucositis or xerostomia) and functional challenges (such as dysphagia) that make eating, drinking, and communicating an extremely difficult ordeal. Patient quality of life is also adversely affected due to psychological distress, rapid weight loss, dehydration, and malnutrition—[and all of that] is often related to the physical side effects of their treatment.

"For cancer patients who are in an intimate relationship, their partner is often their primary caregiver and research has demonstrated that marital status confers a substantial health benefit among cancer patients.

"An analysis of SEER data for the 10 most common cancers found that, even after adjusting for demographics, stage, and treatment type, married patients were 17 percent less likely to present with metastatic disease, 53 percent were more likely to opt for definitive treatment, and 20 percent were less likely to die of cancer than their unmarried counterparts (J Clin Oncol 2013;31:3869-3876).

"Head and neck cancer patients benefited the most—being married reduced their risk of dying from cancer by 33 percent. This risk reduction is greater than the published overall survival benefit for chemotherapy for head and neck cancer (Radiother Oncol 2011;100:33-40). Other studies corroborate these findings and have shown that married head and neck cancer patients have significantly better performance status during treatment than unmarried patients (J Clin Oncol 2006;24:4177-4183).

"One possible reason for this is that spouses of head and neck cancer patients play a critical role in caregiving and encouraging patient self-management during radiation therapy.

"At the same time, the spouses of head and neck patients report high levels of distress of their own. Addressing spouse distress is important in its own right, but at the same time, if the spouse is distressed and they are in a caregiving role, this could adversely affect the care and support that they provide to the patient.

"Thus, to maximize quality of life and health outcomes, it is imperative to address both patient and spouse self-management as well as how the couple relates to one another and coordinates care and support during this critical period."

2. What about for patients who are single? Does this intervention reveal how their care might be improved?

"Because of the research showing that marriage confers a benefit for head and neck cancer patients, I wanted to learn more about spousal relationships in this context and figure out: 1) why they were beneficial and 2) how to leverage spousal support to improve patient care and outcomes.

"Now that we have a clearer understanding of what spouses are doing that contributes to better patient outcomes, we can start thinking about how we can develop programs to teach other informal caregivers (such as family members and friends) to do the same, so that unmarried patients could potentially reap the same benefits."

3. What is the bottom-line message about this research?

"Cancer does not occur in a vacuum. Patients are affected and so are their spouses. Improving patient adherence, well-being, and outcomes requires a broader consideration and acknowledgement of the social and relational context of the patient.

"In head and neck cancers, spousal support and the caregiving that spouses provide [are] important assets. If health care can figure out ways to leverage that support, we have a real opportunity to improve both patient and caregiver outcomes and to improve the overall quality of care that we provide to our patients."

Friday, January 18, 2019

With Wynne Norton, PhD, Program Director in the Division of Cancer Control & Population Sciences at NCI

By Sarah DiGiulio

Health care providers across all disciplines are struggling to provide better care and cut costs. And in oncology, the issue is becoming ever more prescient. New drugs are more effective, but more expensive to make. Better tests and screens are available, but may not be worthwhile for everyone. And the consequences of not delivering sustainable, high-quality cancer care are life-threatening.

That's why Wynne Norton, PhD, Program Director in the Division of Cancer Control and Population Sciences at the NIH, along with her NCI colleagues, wrote a Comments and Controversies article in a recent issue of the Journal of Clinical Oncology outlining a better strategy for studying and de-implementing overuse in cancer care (2018; doi:10.1200/JCO.18.00589).

There are two bottom-line messages from the article, Norton shared with Oncology Times. "First, we wanted to encourage researchers and practitioners to develop and test approaches for effectively de-implementing various cancer-focused practices.

"Second, to support this type of work, we tried to highlight some of the key factors that are likely to play a role in this process, and therefore are likely targets of change needed to facilitate de-implementation," she said.

Norton and her coauthors recognize that de-implementation—especially when you're talking about doing it in cancer care where the stakes are so high—is a "difficult enterprise," they noted in the article. But it's also critical to helping cancer care evolve and improve.

Here's why Norton said establishing a process to accomplish it matters.

1. Why did you and your colleagues decide to write this article now?

"Over the past several years, there has been increasing attention to the issue of overuse of ineffective, low-value, harmful, and unproven practices, interventions, and treatments in the scientific literature—and among professional societies, funding agencies, and research-based organizations.

"Of course, this is a very important issue to patients, providers, and payers, as it cuts across many health conditions, delivery settings, and patient populations.

"We've been involved in several efforts recently to better understand the issue of overuse (e.g., review and summary of grants funded by the NIH on this topic; presentations at the Preventing Overdiagnosis Conference), and to begin to identify ways in which we may either prevent or de-implement the use of these types of practices. Recent high-profile studies in cancer—the TAILORx trial in particular—signaled a timely opportunity for us to summarize issues related to de-implementation.

"Ultimately, we wanted to encourage the research and practice communities to move beyond describing the problem of overuse toward developing and testing ways to de-implement ineffective, low-value, harmful, and unproven practices in cancer care delivery. The overarching goal is to achieve the optimal balance of implementation of beneficial interventions along with de-implementation of harmful or low-value interventions."

2. How would you define what a "de-implementation framework" is and how you came up with this one?

"The de-implementation framework is a conceptualization of multi-level factors that are likely to influence and impact the de-implementation process. We wanted to propose a way of thinking about de-implementation that would simultaneously guide providers, clinic managers, and quality improvement specialists in their practice-based efforts and help researchers identify and test strategies to facilitate de-implementation. We hope it serves as a blueprint for advancing the science and practice of de-implementation.

"[To develop it], first we reviewed the research and practice landscape on overuse, medical reversals, inappropriate use, and low-value care, including seminal work by Drs. Carrie Colla, Deborah Korenstein, Daniel Morgan, Daniel Niven, and Vinay Prasad (among others), prominent campaigns (e.g., Choosing Wisely), and various organizations and agencies (e.g., National Academy of Medicine, Canadian Deprescribing Network).

"[My co-authors] and I had many conversations about these issues and solicited feedback from our colleagues at various conferences and meetings. Along the way, we developed, edited, and refined the de-implementation framework until we had the final version, which is now published in Journal of Clinical Oncology.

"Although we are happy with the framework in its current version, we anticipate that it will need to be revised over time as practice experience and scientific evidence accumulate. We look forward to seeing how others may contribute to this work."

3. What's next and how do you envision cancer care providers and the cancer care community using this framework?

"For providers, clinic managers, quality improvement specialists, and other key players involved in cancer care delivery, we hope this framework will provide an outline for how to identify, prioritize, and facilitate de-implementation.

"For researchers, we hope that the framework highlights many of the key factors that are likely to facilitate or impede the de-implementation process, and leverage this information to develop and test strategies to effectively drive de-implementation (where appropriate) in cancer care delivery settings."