Feasibility and preliminary efficacy of a peer community navigator (PCN)–led intervention for minoritized individuals considering early-phase clinical trials (EPCTs).

Abstract

e23152 Background: EPCTs assess the safety and early clinical activity of new cancer therapies. Underrepresentation of members of racial and ethnic minority groups (REMG) in EPCTs limits accessibility to novel therapies and is influenced by limited knowledge about CTs, mistrust, and structural racism. We conducted a pilot study to assess the feasibility and preliminary efficacy of a peer community navigator (PCN)-led educational intervention for REMG patients with advanced solid tumors (AST) considering EPCT participation. Methods: Participants were English speaking and ≥18 with AST who self-identified as REMG and were referred to the Mount Sinai Early Phase Trials Unit (EPTU). The PCN identifies as Black and is a former EPCT participant and trained peer navigator. The intervention consisted of a virtual call with the PCN to provide an introduction to EPCTs and identify barriers to and concerns about participation before the initial EPTU visit followed by a structured exit interview. The primary endpoint of feasibility was assessed using Bowen’s Framework. Secondary 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. Exit interviews were analyzed by 3 researchers who iteratively developed a codebook and independently coded transcripts using ATLAS.ti to identify emergent themes. Results: Among participants, 7 were male and 11 female; 9 identified as Black, 7 non-Black Hispanic, and 2 multiracial. Median age was 61. Median annual household income was $30K. Of 24 approached, 18 agreed to participate (75%), demonstrating high acceptability. PCN-EPTU communication occurred in all cases (100%), indicating strong integration. 16 of 18 participants completed the intervention (88.89%), exceeding the 80% remote feasibility benchmark. Median CHEKS scores increased from 105.0 (IQR 86.0-108.0) to 117.0 (IQR 111.0-121.0), median delta value 13.0, p < 0.01. No significant differences were observed in median GBMM Scale scores (25.0 [IQR 18.0–34.0] vs. 24.0 [IQR 18.0–25.0]). In exit interviews, all participants indicated they would work with a PCN again. Common themes included increased knowledge and comfort about EPCTs, rapport with the PCN, and increased likelihood to participate. Conclusions: This study supports the feasibility and acceptability of a PCN-led educational intervention to enhance REMG awareness of and interest in EPCTs. Significant increases in CHEKS scores indicated improved CT knowledge. Participant experiences were positive and indicated increased comfort with EPCTs and interest in enrolling. Next iterations will be multilingual and guided by focus group feedback from patients, caregivers, and clinicians.