The development and preliminary evaluation of a financial navigation program among patients with breast cancer in China.

Objective: This study aims to develop a financial navigation program among patients with breast cancer in China and assess its feasibility, acceptability, and preliminary effects on cost-related health literacy and financial toxicity (FT). Methods: The Medical Research Council (MRC) framework were adopted to guide the development of the financial navigation program, providing a structured approach to complex intervention development and evaluation. It consisted of three phases: evidence identification via a scoping review, intervention content modeling through qualitative study analysis, and outcome mapping based on social stress theory. The feasibility, acceptability and primary effectiveness were examined in a single-center, assessor-blinded pilot randomized controlled trial with 26 recruited patients. Results: The financial navigation program consists of needs assessment, cost-related health education, resource/service referral and personalized counseling. The consent rate and a 1-month attrition rate for the feasibility study of the intervention were 55.9% and 7.7%, respectively. Most (91.7%) participants were satisfied with the program and perceived benefits. The intervention significantly improved cost-related health literacy, although no statistically significant between-group difference in FT was observed. Conclusions: The MRC framework serves as a useful scientific basis for developing financial navigation program with a culturally sensitive approach. The financial navigation program was feasible, acceptable, effective in improving cost-related health literacy and has the potential to enhance FT among patients with breast cancer in China. Trial registration: ClinicalTrials.gov Identifier NCT06355440.