Abstract
BACKGROUND: High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance. METHODS: This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs. metastatic) who plan to receive anticancer systemic therapy at one of the participating NCI Community Oncology Research Practices (NCORP). Participants are randomized to receive four up to 1-h remote counseling sessions which include systemic therapy OOP cost communication, financial navigation and counseling (CostCOM intervention) vs. enhanced usual care with provision of an informational brochure for Patient Advocate Foundation (PAF), a national non-profit financial navigation organization (EUC). Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to compare the effectiveness of CostCOM vs. EUC at 12 months on (1) patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns and (2) patient-reported material financial hardship, financial worry, and quality of life; and to (3) conduct a process evaluation to examine practice providers' and CostCOM arm patients' satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM. A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes. TRIAL REGISTRATION: NCT06295367.