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Patient Navigators, Clinician Education Can Remove Barriers to Enrollment in Clinical Trials

August 2019, Vol 12, Special Issue: Payers' Perspectives In Oncology: ASCO 2019 Highlights - Value-Based Care
Chase Doyle

Chicago, IL—Fewer than 7% of adults with cancer and even fewer minority patients participate in clinical trials, which negatively affects the ability to determine the safety and efficacy of new and investigational therapies. At ASCO 2019, 2 experts discussed strategies to overcome the barriers to clinical trial participation and to help enroll more patients with cancer in them.

Improving Risk Assessment Accuracy

Risk-estimation errors and susceptibility to framing can influence a patient’s decision to participate in a clinical trial, according to Kessely Hong, PhD, MPA, Lecturer in Public Policy, Harvard Kennedy School, Cambridge, MA. Because patients tend to focus very heavily on the potential adverse effects of treatment, they may overlook additional strategies or treatment options that could be used to mitigate those side effects or some of the risks associated with the standard of care itself. Moreover, said Dr Hong, these patient risk-estimation errors may be exacerbated by a lack of trust or poor communication.

“Misestimating any probabilities of success or failure, overly focusing on negative outcomes, or not having a good understanding of the compliance burden might cause patients to choose one branch or the other in a way that might not be fully in line with the actual probabilities,” Dr Hong explained. “Several studies have shown that this is particularly likely to be the case when patients are minorities.”

Drawing on the work of Tversky and Kahneman, Dr Hong noted how prospect theory can help clinicians understand the ways in which patients evaluate their potential options based on their starting reference point. Using examples that span a wide array of contexts and decisions, this theory has shown that people are often risk-seeking when they are looking at a loss domain, but they are risk-averse when thinking about things in a gain domain.

“In the case of advanced pancreatic cancer, for example, the standard of care is quite dismal and there is a very high risk of dying in a short time period,” said Dr Hong. “Any clinical trial option that is proposed, even if it carries a risk of more imminent loss or worse side effects, is likely to be embraced, because it offers a tiny sliver of hope of avoiding that certain loss,” she added.

By contrast, for diagnoses for which the standard of care is not as dire, whether that treatment is presented as a positive option (which may provide better outcomes but also the risk of losing the benefit) or a negative option (in which the patient could avoid the loss by participating in a clinical trial) will make a very big difference to a patient’s decision-making. Consequently, there are several strategies to help clinicians and patients make more accurate risk assessments and better-­informed decisions.

Providers’ Education

Dr Hong highlighted several potential risk assessment errors. These included overestimating the burden of compliance among minority patients enrolled in clinical trials, or underestimating the willingness of minority populations to participate in clinical research.

“Clinicians need to be made aware of data showing that when offered the chance to participate in a clinical trial, minority patients actually have very similar rates of clinical trial accrual compared to nonminority patients,” said Dr Hong. “Clinicians should not assume the answer will be ‘no,’ because minority patients are actually willing to participate in trials at similar rates as other patients, if they’re just given the chance,” she pointed out.

Role of Patient Navigators

Patient navigation, which has been shown to be effective across the cancer care continuum, is another strategy for overcoming barriers to clinical trial participation. Patient navigation can enhance communication between patients and clinicians about potential health benefits and risks, as well as the nuances regarding the burden of compliance, according to Electra D. Paskett, PhD, Director, Center for Cancer Health Equity, Ohio State University Comprehensive Cancer Center, Columbus.

“Patient navigation can address multiple barriers to clinical trial participation at multiple levels, and deal with the unique barriers that every different patient has who comes into your clinic,” said Dr Paskett, highlighting that navigators work for the patients not the provider.

“Navigators do not recommend care. Their goal is to identify and address any barrier that a specific patient has to receiving the care that’s recommended by the provider,” Dr Paskett emphasized.

Patient navigators speak to patients in the language they understand, Dr Paskett explained, and they have demonstrated improved metrics with respect to clinical trials, knowledge, intention, and retention. Navigators can easily be integrated into the clinical trial process, but adequate funding is required.

“More institutions need to realize the value and the return on investment for patient navigators and hire them,” Dr Paskett concluded. “Adding patient navigation as a reimbursable service would also be beneficial.”

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Last modified: August 30, 2021