Redefining How to Communicate Treatment Options May Facilitate Equitable Clinical Trial Enrollment

Clinical trials are an integral part of high-quality cancer care, providing patients with access to novel therapies and advancing treatment paradigms. To ensure the generalizability of the results and equitable access to cutting-edge treatments, it is crucial that the enrollment to clinical trials reflects the diversity of the broader patient population. Despite the passing of the National Institutes of Health Revitalization Act of 1993, which mandated the inclusion of women and minorities in federally funded research, trial enrollment among underserved groups remains disproportionately low.^1-8 With underrepresentation, findings from clinical trials may not be generalizable to all populations, thus limiting our understanding of how different groups may respond to treatments. Moreover, it may further contribute to inequitable care across different populations.

Barriers to clinical trial participation are complex and multifactorial. According to a national estimate based on data from the Commission on Cancer, approximately 7.1% of adult patients with cancer participate in clinical trials in the US.⁹ However, when offered enrollment in a study, 55.0% (95% CI, 49.4%-60.5%) of patients enrolled, according to a systematic review published in the Journal of the National Cancer Institute.¹⁰ This emphasizes the importance of offering clinical trials to patients and suggests that low participation in clinical trials may partly be driven by factors other than a lack of willingness from patients, such as patient-physician communication.^11,12 Although many barriers exist outside of the control of the physician, providers’ attitudes and communication strategies are amenable to change.

Furthermore, Black patients are more likely to receive lower-quality care or experience delays in diagnosis, and are less likely to be offered clinical trials compared with White patients.^13-17 It has also been demonstrated that physicians with higher implicit racial bias spend less time in racially discordant interactions (eg, Black patient and non-Black physician).¹⁸ Physicians’ sex bias has also contributed to women less frequently receiving appropriate care than men, as well as delays in cancer diagnoses.^19,20 To ensure equitable access to care and clinical trials, it is imperative that providers use strategies to mitigate bias during encounters with patients.

The American Society of Clinical Oncology provides investigators with a comprehensive framework to ensure effective communication during patient encounters.²¹ They recommend clarifying the goals of treatment prior to discussing options so that patients can contextualize treatment options within their own priorities. When providing treatment options, providers should also discuss the risks and benefits of treatment options in a way that preserves hope but also enables understanding. Importantly, all treatment options, including clinical trials, should be presented to patients.

Considering the challenges that patients face in clinical trial enrollment, understanding how to communicate treatment options to patients of different backgrounds is vital in order to develop interventions that overcome biases in communication and contribute to equitable offers and improved access to clinical trials for all patients. We conducted an observational qualitative study between January 2022 and February 2023 that aimed to characterize treatment options that were discussed with patients, examine differences between these discussions across different racial and sex groups, and assess oncologists’ perceptions of the patient encounter and their level of bias.²² Twenty-one oncologists participated in simulated telehealth encounters with standardized Black and White patients with newly diagnosed metastatic colon cancer who were referred to medical oncology for consultation and discussion of treatment options, including a potential clinical trial.

Notably, nearly all participants discussed a potential clinical trial with patients. Study participants followed a similar structure when discussing clinical trials with patients (Figure 1). However, only 43% of study participants recommended a clinical trial to patients. Additionally, our analysis identified a disconnect between the participants’ perceptions of their communication during simulated patient encounters and their actual behaviors. Although 86% of oncologists thought that they had recommended a clinical trial, only 43% actually did so during the encounters. This discrepancy highlights a gap between oncologists’ intent and execution. Although they may perceive they are providing equitable care, this may not be consistently reflected in their practice. Thus, ensuring that oncologists are equipped with effective communication tools is a critical step toward equitable access to clinical trials.²²

To further address disparities in treatment discussions, the communication tool TrialTALK was developed at the University of Wisconsin (Figure 2). TrialTALK is a communication method that combines verbal elements with a take-home pen-and-paper diagram and is designed to assist investigators with navigating complex treatment discussions with patients. In doing so, the tool aims to organize and facilitate goal-concordant treatment discussions in the clinical setting. A nonblinded, randomized controlled trial assessed the impact of TrialTALK in clinical settings. Results from the study demonstrated that a significantly higher proportion of patients consented to participate in a clinical trial after using TrialTALK during treatment discussions.²³ Moving forward, we aim to test and explore this communication method’s potential to reduce disparities in clinical trial accrual among Black patients by ensuring that all appropriate treatment options, including clinical trials, are presented to all patients regardless of their race and ethnicity.

Ultimately, the complex nature of cancer treatment discussions requires clear and effective communication between oncologists and patients. A structured approach to this complex conversation may help oncologists communicate treatment options to patients in a more effective and consistent manner, which may facilitate equitable clinical trial enrollment.

Samantha Vuong is a medical student at the University of Wisconsin School of Medicine and Public Health.

Monica Patel, MD, is an assistant professor in the Division of Hematology, Medical Oncology, and Palliative Care in the Department of Medicine, as well as faculty director of Diversity and Inclusion in Clinical Research at the University of Wisconsin Carbone Cancer Center.

References

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