Evaluating the impact of financial navigation on financial catastrophe and distress for cancer care in Nigeria: A randomized control trial—COST-FIN.

515 Background: Cancer is a leading cause of premature death in Nigeria, with over 100,000 new cases annually. The most common cancers—breast (BC), colorectal (CRC), & prostate (PC)—have 5-year survival rates below 50% in Nigeria, compared to up to 90% in high-income countries. This disparity is driven by late-stage presentation & significant financial barriers to care, where out-of-pocket costs (OOP) often exceed the country’s per capita GDP. Financial navigation programs (FNPs) have been associated with a reduction in the risk of financial catastrophe (FC) in high-income countries, but its impact in resource-limited settings is unknown. This study assesses the baseline risk of FC among newly diagnosed cancer patients in Nigeria and evaluates the impact of a FNP on financial distress (FD) and risk of FC. Methods: In this pragmatic single-blinded randomized controlled trial, adults (≥18 years) diagnosed within 6 weeks with BR, CRC, or PC at two Nigerian sites were randomized 1:1 to navigation (FNP) or control arm. The study aims to enroll 330 patients with structured interviews captured demographic, treatment, and financial data. FC was defined as health expenditures exceeding 10% of HHI, 25% of total HHE, or 40% of HSE. The FACIT-COST (Comprehensive Score for Financial Toxicity–Functional Assessment of Chronic Illness Therapy) tool—a 12-item survey with scores ranging from 0–44—measured FD. While primary analysis is planned at 6 and 12 months, preliminary data from 122 patients at baseline and 3 months were analyzed using an independent t-test to compare FC & FD between arms. Results: Among the 122 patients (median age: 56 years), 65% are female and 82% married. BC was the most common diagnosis (64%) followed by PC (21%) and CRC (15%). One-fifth (22%) of patients are unemployed. Financial constraints were associated with a delay in diagnosis and treatment for 70%. Surgery, chemotherapy and radiotherapy accounted for the highest treatment costs (45.8%), followed by imaging (26.8%) and consultation fees (7.4%). 70.6% of all expenses were paid OOP. 87.9% were at risk of FC in the control arm with a 7.9% reduction in the FNP arm (80%) at 3 months. There was also an improvement of +1.56 points in FD score in the FNP arm at 3 months, with preliminary 6-month analysis (N = 26) showing a +2.5 increase in the FNP arm at 6-months. These results were not statistically significant. Conclusions: Cancer patients in Nigeria face a high risk of financial catastrophe, contributing to delayed diagnosis and treatment. While currently no statistically significant differences were observed at 3 months and 6-months, the improvement in FD and FC in the FNP arm suggests potential benefit. 6- and 12-month follow-up analysis are crucial to determine whether FNP is associated with a reduction in FC and FD in Nigeria. Clinical trial information: NCT06630962 .