Abstract B039: Feasibility and preliminary efficacy of a pilot community navigator-led intervention for minoritized individuals considering early phase clinical trial participation

Abstract Background: Early phase clinical trials (EPCTs) evaluate the safety and preliminary efficacy of new cancer therapies. However, racial and ethnic minoritized groups (REMG) remain underrepresented, limiting access to novel therapies and representativeness of findings. Barriers to participation include systemic inequities, mistrust in healthcare, and limited knowledge about CTs. This pilot study assessed a community navigator (CN)-led educational intervention for REMG patients with advanced solid tumors considering EPCT participation. Methods: We conducted a single arm study examining participant outcomes before and after the intervention. Eligible participants were English-speaking adults with advanced solid tumors who self-identified as REMG and had been referred to the Mount Sinai Early Phase Trials Unit (EPTU). The CN identifies as Black and is a former EPCT participant and trained peer navigator. The intervention included a virtual educational session before the initial EPTU consultation, providing socioemotional, health literacy, and informational support. The primary endpoint of feasibility was assessed using Bowen’s Framework. Exploratory endpoints included pre- and post-intervention Clinical Trials Knowledge and Beliefs Scale (CHEKS) and the Group-Based Medical Mistrust (GBMM) Scale. Wilcoxon signed-rank tests were used for comparison. Analyses were conducted using PRISM v8.0.2. Results: Between March 15, 2024, and June 5, 2025, 285 patients were referred to EPTU; 40 were eligible and had an initial visit. Of 21 patients approached for the CN-led educational intervention, 15 agreed to participate (71.4%), demonstrating high acceptability. CN-EPTU communication occurred in all cases (100%), indicating strong integration. CN-led sessions were delivered to 13 of 15 participants (86.7%), exceeding the 80% practicality benchmark. Among participants, 7 were male and 8 female; 8 identified as Black (53%), 5 as Hispanic (33%), and 2 as multiracial (13%). Median age was 60 years (range, 43–81) and median annual household income was $30,000. Of patients who agreed to participate, 12 completed baseline assessments and 11 completed the full intervention (dropout rate: 8.3%). Median CHEKS scores increased from 99.5 (IQR 82.5-107.3) to 114.5 (IQR 109.3-119.5), median delta value 12.5, p<0.01. No significant differences were observed in median GBMM Scale scores: 24.0 (IQR 14.8–36.0) compared to 20.0 (IQR 18.0–24.75). Conclusions: This study supports the feasibility and acceptability of a CN-led educational intervention to enhance REMG participation in EPCTs. Statistically significant gains in CHEKS scores suggest improved knowledge and beliefs about trials. These results support a larger study to assess impact on clinical trial knowledge, trust, equitable research access, and EPCT participation. Citation Format: Deborah B. Doroshow, Karen Peterson, Natalie M. Lucas, Annie L. Chen, Olivia Hapanowicz, Gabriela Fazilov, Kaberi Dhar, Marina Serrano Fernandez, Taira Anderson, Cardinale Smith, Melissa Mazor. Feasibility and preliminary efficacy of a pilot community navigator-led intervention for minoritized individuals considering early phase clinical trial participation [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr B039.