Financial navigation for people newly diagnosed with cancer: Results from the CAFÉ randomized trial.

295 Background: Evidence-based interventions to mitigate cancer-related financial hardship are limited. Cancer Financial Experience (CAFÉ) is a financial navigation intervention developed to reduce financial hardship among individuals with cancer. Methods: We conducted a randomized controlled trial at two integrated health systems. Inclusion criteria were age 18+ and receiving care for a new cancer diagnosis at a study site. We prioritized recruitment of people receiving Medicaid, underrepresented race/ethnicity, and Spanish speakers. Participants were randomized 1:1:1 to one of three study conditions: brief intervention (B): one proactive outreach + 6 months of navigation, extended intervention (E): three proactive outreaches + 6 months of navigation; enhanced usual care (UC): mailed financial resource sheet. Trained financial navigators assessed financial concerns and provided personalized support, referrals, and navigation to resources, consulting with care teams as needed. Primary outcomes were self-reported financial hardship (InCharge financial well-being scale; range 1-10, higher scores indicate higher well-being) and health-related quality of life (FACT-G7, range 1-28, higher scores indicate higher quality of life), assessed at 12 months. To analyze primary outcomes, we fit GLM models adjusting for site, cancer site, diversity sample, and demographics, using inverse probability weighting to adjust for survey nonresponse bias. We examined heterogeneity of treatment effect in subgroups by age (< 65, 65+), sex, baseline financial well-being, social need, and the prioritized recruitment group. Exploratory outcomes included COST score, perceived care quality, treatment decision satisfaction, trust in healthcare, and patient support services used during follow-up. Results: The sample (n = 371) was 63% women, 64% white, 61% married, 53% college graduate or more, and 62% annual household income > $50,000. Among survey respondents at 12 months (n = 283), financial hardship and quality of life were similar between intervention groups (InCharge, unadjusted mean (SD): B = 7.39 (2.66); E = 6.84 (2.55); UC = 6.69 (2.66), adjusted p.0.73; FACT-G7: Brief = 19.1 (5.1), Extended = 19.0 (5.2), Usual Care = 19.2 (5.2), p = 0.17. There was no evidence of treatment effect in subgroup analyses. Exploratory analyses suggested no differences between study arms by COST score, decision satisfaction, or trust in health care; slightly higher perceived care quality was reported in the extended intervention group. Use of patient support services was similar between intervention arms. Conclusions: Financial navigation was not associated with financial hardship or health-related quality of life in newly diagnosed cancer patients in an integrated care system. Continued research on strategies to address the urgent problem of cancer-related financial hardship is needed. Clinical trial information: NCT05018000 .