Effect of a financial navigation intervention on financial toxicity among patients with breast cancer: A randomized controlled trial in China.

1520 Background: Financial toxicity (FT) is a common and burdensome consequence of breast cancer treatment, adversely affecting patients’ psychological well-being, treatment adherence, and quality of life. Financial navigation (FN) has been proposed as an effective strategy to mitigate FT; however, high-quality randomized evidence evaluating its impact on patient-centered outcomes remains limited. Methods: This assessor-blinded, parallel-group randomized controlled trial enrolled adult female patients with breast cancer who had undergone surgery and were receiving or scheduled for adjuvant therapy. Participants were randomized to an FN intervention or usual care (n = 41 per group). The FN intervention included individualized needs assessment, cost-related health education, referral to financial and social resources, and personalized counseling. Outcomes were assessed at baseline (T0), 1 month (T1), and 3 months (T2) post-discharge. Primary outcome was FT, with secondary outcomes including cost-related health literacy (CRHL), shared decision-making (SDM) ability, and perceived stress. Intention-to-treat analysis using generalized estimating equations was applied. Results: Of 311 patients screened, 82 were enrolled. Compared with controls, the FN group demonstrated significantly lower subjective FT at T1 (mean difference = 4.76, 95% CI 0.75–8.76, P = 0.020) and T2 (mean difference = 4.66, 95% CI 0.94–8.37, P = 0.014). CRHL significantly improved at T1 (mean difference = 3.15, 95% CI 0.91–5.38, P = 0.006) and further increased at T2 (mean difference = 5.56, 95% CI 3.53–7.59, P < 0.001). SDM ability was also higher in the FN group at T2 (mean difference = 3.24, 95% CI 0.47–6.00, P = 0.022). No significant effects were observed in material or behavioral FT domains. Perceived stress was higher in the FN group at T2 ( P = 0.032). Conclusions: This randomized controlled trial demonstrates that financial navigation is an effective intervention for alleviating subjective financial toxicity and improving cost-related health literacy and shared decision-making among patients with breast cancer. By providing rigorous randomized evidence, this study advances the field beyond descriptive and observational research and offers high-level evidence supporting financial navigation as a clinically actionable strategy to address cancer-related financial toxicity. These findings contribute to the global effort to mitigate financial toxicity and support the integration of structured financial navigation programs into survivorship care models across diverse healthcare settings. Clinical trial information: NCT06484140 .