Understanding the Barriers to Clinical Trial Referral and Enrollment Among Oncology Providers Within the Veterans Health Administration

Abstract

ABSTRACT Introduction Clinical trials are essential for advancing treatment options in oncology while providing cancer patients with innovative care; however, few cancer patients are referred to clinical trials. System-, provider-, and patient-level barriers to clinical trial participation have been described but have not been studied in the Veterans Health Administration (VHA). Although the VHA has engaged in several initiatives to improve Veteran’s access to clinical trials, including the National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment program and VHA work on the White House Cancer Moonshot, further research is needed to understand the multifaceted challenges underlying limited enrollment for Veterans who receive care in the VHA system. This research aims to evaluate VHA oncology providers’ attitudes toward and experiences with referral and enrollmentof Veterans with cancer into clinical trials, for the purpose of informing actions that could be taken to enhance Veterans’ access to clinical trials as well as the VHA’s contributions to clinical research. Materials and Methods This research comprised the administration of an electronic 34-item survey and semistructured interviews among oncology care providers in the VHA nationally, between May 2022 and August 2023. The survey was introduced via a presentation at VHA Oncology Office Hours and aimed to capture VHA oncology care providers’ perceptions of and experiences with referral and enrollment to clinical trials. The semistructured interviews explored providers’ perceived barriers to clinical trial participation and recruitment bias, as well as inquired about potentially modifiable factors for improving clinical trial enrollment at the VHA, such as providers’ concerns, motivations for and facilitators of enrollment of patients into clinical trials, and the manner in which they communicate about clinical trials with their patients. Results Thirty-eight oncology care providers completed the survey, and eight completed the semistructured interview, including 5 staff physicians, 1 fellow, 1 nurse practitioner, and 1 physician assistant. Thirty-four survey respondents identified their specialty as medical oncology, one respondent identified the specialty as radiation oncology, and three identified the specialty as hematology. Nineteen respondents identified as women and 14 as men; the remainder did not provide their gender. Three respondents identified as Hispanic or Latino individuals, 11 as Asians, 3 as Black individuals, and 17 as White individuals. Five interview participants reported holding an individual academic affiliation. Participants identified and described various barriers to clinical trial referral and enrollment at multiple levels, including lack of appropriate trials, strict patient eligibility criteria, difficulties in understanding and managing the referral process for trials outside the VHA system, challenges with obtaining information and identifying available clinical trials, Veterans’ financial and logistical concerns, lack of trust in the medical establishment, lack of adequate social support, and Veterans’ psychological and physical comorbidities. They also highlighted opportunities for system-level change that can overcome some of these barriers, including academic affiliations, patient support from internal and external nurse navigators, and dedicated research coordinators. Conclusions The insights gleaned from this research can guide VHA in its efforts to optimize access to clinical trials for Veterans.