August 2, 2025

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)

Key Points

MAIN FINDING: The mobile health intervention is expected to significantly enhance quality of life for Black prostate cancer survivors.
KEY EVIDENCE: Primary outcomes include improved FACT-P scores and reduced mental health issues like anxiety and depression.
APPROACH: A 12-month trial will include 248 Black prostate cancer survivors in intervention and control groups.
SIGNIFICANCE: Findings will guide culturally tailored interventions to improve survivorship care for diverse populations.

Abstract

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

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