Work

Improving access to therapeutic clinical trials: a randomized controlled trial of GUIDE navigation and reimbursement

Year: 2026

Type: article

Abstract: Introduction Disparities in access to cancer clinical trials persist among patients with limited socioeconomic resources. Clinical trial navigation programs are an emerging solution to improve clinical trial access, although their components are varied and not well-described. Methods Guiding participation toward Understanding, Inclusion, Diversity, and Equity in Cancer Clinical Trials (GUIDE) is an evidence-based clinical trial navigation program that focuses on financial reimbursement for trial-related expenses and clinical trial navigation services, including local resource connections. We are conducting a pilot randomized controlled trial of 100 adults with cancer who are eligible for a clinical trial to evaluate GUIDE implementation outcomes and preliminary efficacy in increasing clinical trial enrollment and retention, reducing the financial burden and resolving health-related social needs, and increasing patient trust, health-related quality of life, and resilience. Staff time and effort, participant time, overheads, and reimbursement costs of GUIDE will also be evaluated. Participants are randomized 1:1 to GUIDE with usual care versus usual care alone for a 6-month period. Usual care includes institutional social work and patient and financial navigation support. Discussion Although disparities in clinical trial participation may be addressed by clinical trial navigation programs, components of effective programs are not well-understood, in part due to a paucity of published protocols. To address these critical gaps in clinical trial representation and navigation program transparency, we present the GUIDE protocol. Clinical Trial Registration ClinicalTrials.gov, identifier NCT06484595.

Source: Frontiers in Cancer Control and Society

DOI: 10.3389/fcacs.2026.1794900