Journal Article

Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials

Hulsey, Thomas, Gao, Ang, Rojas, Marisol, Eluri, Venkata, Makhnoon, Sukh, Gerber, David E., Kitzman, Heather, Grant, D'Angelo, Renn, Rebecca, Zhang, Song, Williams, Erin L., Lee, Jessica L., Sadeghi, Navid, Robles, Fabian, Pezzia, Carla

2025

Overview

Background Achieving adequate, timely, and diverse trial enrollment remains a major challenge in clinical research. Insufficiently diverse patient representation compromises the generalizability of clinical trial findings and remains a persistent issue in oncology. Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to trial enrollment and retention. Methods We implemented a patient navigation program to support diverse enrollment and retention of patients in cancer clinical trials; the proximal outcomes were receipt of financial navigation and trial interest. The study was conducted from July 2023 to July 2024 at two demographically diverse health care settings: a university‐based tertiary healthcare system and an integrated safety‐net healthcare system. Evaluation was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and incorporated programmatic data, structured surveys of patients and staff, and qualitative patient interviews. Results The program navigated 429 oncology patients (52% female, 28% Hispanic/Latino (HL), and 16% non‐HL Black). Compared to the underlying patient population of the clinical settings, program participants were more likely to be Hispanic (31% vs. 21%; p < 0.01), female (52% vs. 48%; p = 0.01) and from a minority race (30% vs. 24%, p ≤ 0.01). Within the population who were successfully contacted, 325 of 408 (92%) patients already enrolled in a trial received financial navigation to help with trial retention. Among the remaining 83 patients not enrolled in a cancer clinical trial at the time of referral, 39 (47%) expressed interest in participating in a clinical trial in thefuture. Conclusion A patient navigation program to influence enrollment and retention of diverse patients into trials was feasible to implement, highly acceptable to patients, and reached a priority population of patients generally underrepresented in cancer clinical trials. Further research into the effect of navigation on trial enrollment and retention is warranted.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Academic Medical Centers - organization & administration / Aged / Cancer / Clinical trials / Clinical Trials as Topic - organization & administration / Clinics / Demography / diversity / Educational materials / Evidence-Based Practice - organization & administration / Female / Health care / Health Plan Implementation / Humans / implementation science / Interviews as Topic / Male / Medical records / Medical screening / Middle Aged / Neoplasms - therapy / Oncology / Participation / patient navigation / Patient Navigation - organization & administration / Patient Participation / Patient Selection / Patients / Polls & surveys / Qualitative Research / Safety-net Providers - organization & administration / Sustainability / Teams / Tertiary Healthcare - organization & administration