Multidimensional barriers and facilitators to early phase clinical trial (EPCT) participation among diverse patients with advanced solid tumors.

Abstract

117 Background: Early phase clinical trials (EPCTs) are critical for oncology innovation and access to novel therapies, yet members of minoritized communities remain underrepresented as a result of complex psychosocial, structural, and systemic barriers. Understanding the varying perspectives of patients, caregivers, and clinicians is essential to improving equitable access. Methods: As part of a qualitative study regarding community navigators for minoritized potential EPCT participants, focus groups were conducted in English and Spanish with EPCT participants (n=5) who self-identified as Hispanic or Black and caregivers of such patients (n=4). Semi-structured interviews were also conducted with clinicians (n=5) in the Mount Sinai Early Phase Trials Unit. Transcripts were coded in ATLAS.ti, employing thematic analysis to identify core drivers of trial participation and refusal. Results: Analysis revealed four primary thematic domains: communications gap, systemic and language barriers, altruism vs. fear of the unknown, and trust between clinicians and patients. Communications gap: Patients and caregivers reported profound initial lack of familiarity with EPCTs and clinical trials in general. Clinicians highlighted common fundamental misunderstanding of Phase I goals which they perceived as exacerbated by low health literacy and socioeconomic status. Systemic and Language Barriers: Language discordance emerged as a critical barrier; clinicians admitted to offering trials less frequently to non-English speakers due to time constraints and "cold" interpreter interactions. Clinicians noted that logistical burdens, specifically frequent visits, transportation, and associated costs disproportionately affected lower-income families, while patients and caregivers described few practical burdens. Altruism vs Fear of the Unknown: Patients and caregivers characterized decision-making as a tension between fear (of being a "guinea pig" or experiencing unknown toxicity) and hope. Participants frequently cited altruism and the perception of having "nothing to lose" or being in a state of desperation as primary motivators. Trust as a Mediator: The clinician-patient relationship was the strongest facilitator of enrollment. Patients relied heavily on the recommendation of their primary oncologist, while clinicians used transparency to build trust with minoritized groups. Conclusions: Barriers to EPCT participation among a group of minoritized trial participants and caregivers were driven by a combination of limited awareness, language barriers, logistical intensity, fear of uncertainty, and historical distrust. To foster equitable access, clinical teams must move beyond "equal offering" toward equitable support using education, language concordant materials and personnel, and trust-building with patients and families.