Addressing financial and health-related social needs among patients with cancer: Study protocol for CAN-ASSIST Pilot Clinical Trial

Financial hardship and health-related social needs (HRSNs) are prevalent among cancer patients and contribute to disparities in outcomes. Addressing these issues can reduce harm, yet routine screening and intervention remains underutilized. Navigator-led interventions such as combining out-of-pocket cost (OOPC) communication and financial navigation (CostCOM) have shown promise, but face implementation barriers due to navigator shortages. It is unclear whether financial education and resource access alone (FinEd), without navigator support, can meet patients’ needs. We propose a three-arm pilot randomized controlled trial comparing FinEd, enhanced usual care (EUC) and CostCOM in 90 newly diagnosed cancer patients undergoing systemic or radiation therapy who screen positive for financial hardship or HRSNs. FinEd includes (1) a list of local/national resources for financial and HRSNs support, and (2) educational materials on health insurance, delivered via mail and a one-time phone/video session with a study coordinator. CostCOM includes (1) systemic therapy OOPC estimates, (2) financial navigation to identify assistance programs, and (3) financial counseling, delivered over two phone/video sessions by a financial navigator. EUC includes study-specific identification of financial hardship and HRSNs. Our goals are to investigate preliminary efficacy of the three arms within six months post-randomization on cost-related care non-adherence (primary outcome), treatment completion, missed appointments, financial worry, material hardship, insurance literacy, quality of life, and sleep quality. We will evaluate patient experience with FinEd using qualitative interviews. This study will support feasibility for a larger trial, and provide initial efficacy estimates comparing FinEd vs. EUC vs. CostCOM in improving cancer outcomes. Clinicaltrials.gov NCT06430840; registered 5/24/2024; https://clinicaltrials.gov/study/NCT06430840?cond=NCT06430840&rank=1