A 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

e23127 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 symptoms related to their cancer and previous treatments. EPCTs often require frequent visits and additional procedures which may be burdensome. 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, SDoH barriers and navigator interventions between the EPCT and non-EPCT pt groups. Results: From February to December 2023, 31 EPCT pts and 3126 non-EPCT pts completed the assessment. Median age was 55.9 and 56.1 years, respectively. Racial and ethnic self-identification included 13% vs. 23% Black pts and 19% vs. 20% Hispanic pts. EPCT pts had a mean 4.87 navigation encounters per pt compared to 1.94 in non-EPCT pts (p < 0.001). Pts in the EPCT group were found to have an average of 24.97 SDoH barriers identified, in contrast to 2.68 in the non-EPCT group (p < 0.001). The most common barriers identified in EPCT pts were institutional, knowledge, and psychosocial; in non-EPCT pts, institutional, treatment adherence, and transportation barriers were most common. Furthermore, based on the identified barriers, EPCT pts required an average of 17.23 interventions, compared to 1.80 among those not in the EPCT group (p < 0.001). Interventions most frequently involved coordination with the primary team and education for pts in both groups. Conclusions: EPCT pts had more navigation encounters, SDoH barriers identified, and resultant interventions than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. [Table: see text]