Jimoh, Mutiu

Abstract Background: As with most Sub-Saharan African countries, Nigeria has a rising incidence of cancer, with disproportionate mortality rates. The financial burden of cancer care often results in catastrophic healthcare spending, leading to treatment refusal, disruption, and discontinuation. This is particularly significant in Nigeria, where nearly all patients are uninsured, and out-of-pocket costs often exceed households’ ability to pay. Financial Navigation Programs (FNPs) have been shown to mitigate treatment-related financial toxicity in cancer care and reduce treatment abandonment, but there is a paucity of high-quality data on this intervention in resource-constrained settings. Here, we present a randomized controlled trial to evaluate the impact of a novel FNP in Nigeria. Methods: We designed the COST-FIN trial, a multi-site pragmatic single-blinded randomized controlled trial of newly diagnosed (<6 weeks from diagnosis) adults (≥18 years) with breast, colorectal, or prostate cancer at two tertiary cancer centers in Nigeria. Participants (n=200) will be randomized (1:1) to either the intervention (FNP) or the control arm and followed for 12 months. Data on key individual, treatment, and financial parameters will be collected via structured interviews and chart abstraction at baseline, 3, 6, and 12-month follow-up. In addition, participants randomized to the FNP will receive a tailored financial literacy assessment, financial planning support, and enhanced access to resources by trained financial navigators. Primary and secondary outcomes are Financial Catastrophe (FC) and Financial Distress (FD), respectively. Exploratory outcomes will include cost-related non-adherence and cost-effectiveness of the program. An interim analysis will be conducted when 50% of the estimated accruals reach 6 months of follow-up, with crossover if compelling evidence of benefit is demonstrated at that time point. All participants will be followed for 12 months from recruitment. Discussion: This first-of-its-kind study will provide evidence on the role of FNP in potentially eliminating financial barriers to cancer care in Nigeria. Given the country’s renewed interest in cancer control through the passage of the National Cancer Control Plan, findings from this study have the potential to influence policy reform and set the stage for further studies to evaluate the scalability and implementation of similar interventions in resource-limited settings. Trial registration : ClinicalTrials.gov NCT06630962. Oct 8, 2024 (https://clinicaltrials.gov/study/NCT06630962)

Abstract Background: The need to increase understanding of prostate cancer (CaP) is ever increasing. Unfortunately, there is limited understanding of how CaP affects men of African ancestry (MAA) despite significant disparities in CaP prevention, diagnosis, and treatment due to genetic and sociobehavioral factors. Conducting CaP clinical trials (CTs) in Africa presents multiple opportunities to improve upon collective knowledge of CaP in MAA experiences, expand patient access to CTs, and provide opportunities for African scientists and urologists to contribute to research on the global stage. The International Registry of Men with Advanced Prostate Cancer (IRONMAN) seeks to reduce CaP disparities by sponsoring sites throughout Africa. Four Prostate Cancer Transatlantic Consortium (CaPTC) institutions in Nigeria currently participate in IRONMAN: University of Ilorin Teaching Hospital, Federal Medical Center, University of Maiduguri, and Lagos State University Teaching Hospital. Because CTs of this scale are infrequently conducted in Africa, there are special considerations when conducting CTs in low-middle-income countries (LMICs) like Nigeria. Methods: Hourlong interviews dedicated to site staff were conducted via Zoom in Spring 2023 (four total). Interviews utilized a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis approach. Each interview was recorded, transcribed, and validated by study staff for accuracy. Themes from each were inductively coded and then collated across all four sites. Results: The urologists, oncologists, phlebotomists, pathologists, nurses, research coordinators that make up the study teams identified the holistics of conducting the IRONMAN study at their sites. Strengths included a large patient population to recruit from and appropriate resources to conduct the study (ex., lab space, clinical knowledge, staffing levels). Weaknesses included the social determinants of health that negatively impact patient participation, limited biorepository space to store samples, and the need for patient-physician trust. The greatest opportunity presented was Nigerian institutions joining more CTs in the future, particularly multi-site global trials. Described threats included staff turnover, national stability, and increased economic disparities. Discussion: While increasing the overall number of CTs in Africa is a noble cause, sponsors and institutions should note the unique circumstances in implementing CTs in Africa when designing CTs and recruiting sites. Listening to the experiences of study teams is pivotal in ensuring CTs are Africa-minded - they will be complimentary to established research infrastructure, appropriately funded, and culturally responsive all in the name of equitable research. By doing so, ethical compliance and quality data collection will ensue and reduce disparities at the micro, mezzo, and macro levels. Citation Format: Opeyemi Oreoluwa Bolajoko, Parisa Fathi, Oluwaseyi Toye, Dottington D. Fulwood, Ademola Popoola, Chidiebere Ogo, Hassan Dogo, Omolara Fatiregun, Anthonia Sowumi, Paul Jibrin, Mutiu A. Jimoh, Faruk Mohammed, Folakemi Odedina, Prostate Cancer Transatlantic Consortium. Strengths, weaknesses, opportunities, and threats of conducting clinical trials in Nigeria: The IRONMAN study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1013.