Abstract B059: Patient-reported barriers to clinical trial enrollment: A site-level analysis of DCP-001 non-enrollees at an academic medical center

Abstract

Understanding why eligible patients with cancer decline clinical trial participation is critical to developing targeted accrual interventions. DCP-001 is a National Cancer Institute (NCI) Division of Cancer Prevention protocol within the NCI Community Oncology Research Program (NCORP). The protocol systematically captures patient-reported reasons for non-enrollment at the point of trial decision-making, which provides information rarely available through administrative databases or chart review. At present, there remains a paucity of site-level analyses, which can reveal locally actionable patterns obscured in aggregate data. This secondary analysis included adults ≥18 years enrolled on DCP-001 from 2017–2024 at the Columbia University Herbert Irving Comprehensive Cancer Center (NCORP) and affiliated sites. Patients eligible for a therapeutic or supportive care study who declined participation were included in the present analysis. Sociodemographic data were collected via the DCP-001 tool and included age, sex/gender, race/ethnicity, country of origin, primary language, education, employment, income, insurance, and marital status. Reasons for non-enrollment were classified into six domains and grouped as personal (autonomy, toxicity concerns, lack of interest) or logistical (access, time, provider timing/communication). Associations between barrier type and sociodemographic factors were assessed using chi-square tests (two-sided P<0.05). Of 498 eligible patients, 324 (65%) enrolled on DCP-001; of these, 219 (68%) enrolled on an NCORP trial (170 [53%] supportive care; 49 [15%] treatment). Enrollment was not associated with race/ethnicity, education, income, or insurance. Non-enrollees had a median age of 57 years, 67% were female, and the group was diverse (40% non-Hispanic White, 35% Hispanic, 18% non-Hispanic Black, 5% Asian). The most common reasons for non-enrollment were autonomy concerns (26%), toxicity concerns (19%), and lack of interest (19%), followed by time constraints (17%), provider timing/communication (16%), and access (12%). Overall, 54% cited personal reasons and 37% logistical reasons. Personal reasons were similar by nativity (61% vs. 62%), but U.S.-born patients reported fewer logistical barriers (24% vs. 38%; P = 0.002). Similarly, English-speaking patients more often cited personal reasons (65% vs. 40%) and less often logistical barriers (23% vs. 60%; P = 0.001). Barrier type was not associated with race/ethnicity, age, education, income, or insurance. Among a diverse cohort of trial-eligible patients who declined participation, personal concerns, particularly about autonomy and toxicity, predominated over logistical barriers, but profiles varied by nativity and language. Site-level DCP-001 data offer a unique window into the decision-making of patients who decline clinical trials and can inform distinct, locally tailored interventions. Supported by NCORP Grant 3UG1CA189960-11S1 and the Blood Cancer United Scholar in Clinical Research Award. Justine M. Kahn, Melissa Beauchemin, Erik Harden, Kathryn McHenry, Rohit Raghunathan, Susan Bates, Yeun-Hee A. Park, Stephanie Smith-Marrone, Nancy Mills, Natalie Berger, Mariana Molero. Zambrano, Bruno Bastos, Ashley Johnson, Ian Bhatia, Katherine D. Crew, Dawn Hershman, Jennifer E. Amengual, Lisa A. Kachnic. Patient-reported barriers to clinical trial enrollment: A site-level analysis of DCP-001 non-enrollees at an academic medical center [abstract]. In: Proceedings of the 19th AACR Conference on the Science of Cancer Health Disparities; 2026 Oct 18-21; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2026;35(10 Suppl):Abstract nr B059.