Patient, caregiver, and clinician perspectives to inform a peer community navigator intervention for early-phase clinical trials participation.

Abstract

118 Background: Black and Hispanic patients remain underrepresented in early-phase cancer clinical trials (EPCTs), limiting equitable access to novel therapies. Building on a pilot study of a community navigator (CN)-led intervention that was feasible, acceptable, and had positive stakeholder feedback, we conducted a qualitative assessment to inform a culturally responsive CN intervention for patients considering EPCT enrollment. Methods: We conducted a single-center qualitative study at the Mount Sinai Early Phase Trials Unit using focus groups with Black and Hispanic EPCT participants and caregivers and semi-structured interviews with clinicians involved in EPCT care. Focus groups were conducted in English and Spanish. Participants reviewed a proposed CN intervention and provided feedback on acceptability, usefulness, timing, content, delivery, and implementation barriers. Sessions were conducted via HIPAA-compliant Zoom, transcribed, coded in ATLAS.ti with 88.5% intercoder agreement, and analyzed thematically. Results: Fourteen stakeholders participated: 5 clinicians, 5 patients, and 4 caregivers. Clinicians included oncologists, program managers, and a patient navigator, with median 4 years of EPTU experience. All patients and caregivers self-identified as Black or Hispanic and reported English or Spanish as their primary language. Stakeholders emphasized that the CN should be a trained interventionist supported by a structured curriculum, and clinicians highlighted clear boundaries from the clinical team. Four priorities emerged. First, language-concordant support and culturally responsive communication were central to building trust. Second, stakeholders endorsed a pre-visit navigator encounter before the oncology appointment and identified key topics: EPCT basics, patient concerns, language-concordant written materials, and preparation for discussion with the trials team. Third, stakeholders recommended post-visit support to consolidate information, reassess concerns, and communicate unresolved questions or barriers. Fourth, participants favored a flexible model that could include in-person, telephone, or video support; variable frequency; and family involvement if desired, while minimizing added burden. Clinicians favored standardization, whereas patients emphasized individualized support. Conclusions: Stakeholders supported a culturally responsive CN intervention for patients considering EPCT enrollment. Key components included language-concordant support, structured navigator training, pre- and post-visit navigation, flexible delivery, and family involvement if desired. These findings will guide refinement of the navigator manual, workflow, and materials before pilot testing to improve equitable access to EPCTs among Black and Hispanic patients.