A Quasi-Randomized Controlled Trial of a Culturally Tailored Mobile Health Intervention to Improve Quality of Life in Black Prostate Cancer Survivors: A Study Protocol (Preprint)

BACKGROUND Prostate cancer (CaP) disproportionately affects Black men (BM) in the United States, leading to significant disparities in incidence, survival, and quality of life (QoL). Treatment-related side effects, including urinary dysfunction, pain, fatigue, and psychological distress, contribute to poor long-term outcomes. There is an urgent need for culturally-tailored, technology-based interventions to support symptom self-management and survivorship care. OBJECTIVE This study aims to develop, refine, and evaluate the Survivorship App for Ethnically Diverse Black Prostate Cancer Survivors (SAFE-CaPS), a mobile health (mHealth) intervention designed to enhance QoL, improve symptom self-management, and provide psychosocial support. METHODS This 12-month, quasi-randomized clinical trial will enroll 248 Black CaP survivors into the SAFE-CaPS intervention arm and standard care (SC) control group (1:1 allocation). SAFE-CaPS will offer real-time symptom tracking, educational content, and engagement strategies. Primary outcomes include changes in QoL (FACT-P scores), mental health (depression, anxiety), and healthcare engagement, assessed at baseline, 3, 6, 9, and 12 months. Linear mixed models and intent-to-treat analysis will be employed to assess the efficacy of the intervention. RESULTS SAFE-CaPS is expected to significantly improve QoL, reduce symptom burden, and enhance healthcare engagement among Black CaP survivors. Findings will inform scalable, culturally-tailored survivorship interventions for ethnically diverse populations. CONCLUSIONS This study will provide critical evidence on the feasibility, acceptability, and preliminary effectiveness of a culturally tailored mobile health intervention designed to enhance survivorship outcomes among Black CaP survivors, informing future large-scale trials and real-world implementation. CLINICALTRIAL ClinicalTrials.gov, NCT06651359; https://clinicaltrials.gov/study/NCT06651359