High-volume patient navigator encounters and access to oncology clinical trials.

Abstract

e23227 Background: Only 7% of US adults with cancer enroll in clinical trials, despite a rising number of clinical trials available. Barriers to trial participation extend beyond clinical eligibility and include social determinants of health such as logistical and insurance related factors. Timely and consistent patient navigation is needed to address these barriers. The Trial Library platform includes a navigation operating system to facilitate end-to-end support to eligible patients. Methods: he Trial Library platform was integrated in community oncology settings from January 1, 2025, to December 31, 2025. Patient referrals were captured in a HIPAA-compliant platform and triggered navigation. Navigation support included trial eligibility verification and patient care coordination, including assistance with logistical and insurance authorization-related barriers. Navigator encounters involved patients, healthcare providers, study sites, and/or insurance personnel. High navigation volume was defined as ≥ 10 navigation encounters per referral. Associations between navigation volume and patient and trial characteristics were examined using Firth penalized likelihood logistic regression. Results: The platform supported 131 patients, with a median of 7 encounters per referral (range: 1-88); 36% of referrals (47/131) required a high volume of navigation encounters. In univariable analyses, older age, male sex, and referral for interventional trials, compared to observation trials, were associated with high navigation encounter volume, whereas cancer type was not (Table). All high navigation volume encounters occurred among male patients, resulting in complete separation. Conclusions: Navigation needs varied markedly by trial type and patient characteristics, with higher utilization observed among patients referred for interventional trials. These findings highlight the importance of robust patient navigation infrastructure to address non-clinical barriers and support expansion of clinical trial access. Association of high navigation encounter volume with patient and trial characteristics. OR (95% CI) p-value Age (Continuous) 1.05 (1.01 - 1.10) 0.007 Cancer type (Hematologic vs Solid) 0.95 (0.10 - 8.24) 0.9 Sex (Female vs Male) 0.04 (0.0003 - 0.29) < 0.001 Trial type (Interventional vs Observational) 5.93 (2.51 - 14.91) < 0.001