An updated comparative analysis of needs and role of patient navigation among early phase cancer clinical trial participants and non-participants at a single cancer center.

Abstract

237 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptom burdens. EPCTs may add to these burdens by requiring frequent, long visits and additional procedures. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters and SDoH barriers between the EPCT and non-EPCT pt groups. Results: From February 2023 to April 2024, 40 EPCT pts and 1290 non-EPCT pts completed the assessment. Median age was 60.5 and 63.1 years, respectively. Racial and ethnic self-identification included 17.5% vs. 19% Black pts and 10% vs. 17% Hispanic pts. EPCT pts had a mean 5.2 navigation encounters per pt compared to 3.05 in non-EPCT pts (p=0.002). Pts in the EPCT group were found to have an average of 2.8 SDoH barriers identified, in contrast to 2.0 in the non-EPCT group (p=0.002). The most common barriers identified in EPCT pts were institutional, knowledge, psychosocial and financial; in non-EPCT pts, transportation, institutional, knowledge and treatment adherence were most common. Interventions related to institutional barriers most frequently involved coordinating with the primary team and among departments. Interventions related to knowledge included providing education and teach back. Conclusions: EPCT pts had more SDoH barriers identified, higher acuity of barriers, and required more navigation encounters than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. EPCT pts Non-EPCT pts p value Navigation encounters, mean (SD) 5.20 (6.16) 3.05 (4.34) 0.002 SDoH barriers identified, mean (SD) 2.82 (1.83) 2.00 (1.66) 0.002