NCT06651359

Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors

Development and Preliminary Evaluation of a Tailored mHealth App Designed to Improve Quality-of-Life Outcomes in Ethnically-Diverse Black Prostate Cancer Survivors (SAFE-CaPs)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to ensure that the mobile health application for Black patients with prostate cancer (either actively undergoing treatment or survivors) is usable and acceptable to patients, get feedback about how to improve the app and assess its usefulness in examining their quality of life.

Detailed description

The purpose of this study is to test the effectiveness of a culturally appropriate and specific mobile app for ethnically diverse Black men with prostate cancer (either those actively undergoing treatment or survivors) to empower them to be active participants in their care. This app will provide 1) relevant information/education about prostate cancer-specific to Black men; 2) symptoms monitoring - allowing participants to report difficulties and prompting providers to respond to concerns; and 3) testimonials from other patients with shared experiences. All participants will be asked to complete surveys online when they start and then again at 3, 6, 9, and 12 months. A subset of randomized participants will be provided access to this app, which they will be asked to use at home for 12 months. The app users will answer daily surveys about their symptoms and activities as well as weekly mood assessments for 3 months. At the end of the 12 months, interviews will be conducted to receive feedback regarding the app.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Surveys for Quality of Life	This group will take scheduled electronic surveys (at the beginning of the study, months 3, 6, 9, and 12) to assess the overall impact of prostate cancer on quality of life (QoL).
BEHAVIORAL	Surveys and mHealth App access	This group will take scheduled electronic surveys (at the beginning of the study, months 3, 6, 9, and 12) to assess the overall impact of prostate cancer on quality of life (QoL). Additionally, they will have a brief "initial study visit," in-person or virtually, to review the app use. This arm of participants will use the mobile application at home for 12 months. During the first 12 weeks, the application will send daily surveys about symptoms, dietary and physical activities, weekly surveys about their mood, and an assessment of their overall QoL every 3 months. The app will provide tailored educational content, including short readings, videos, and audio recordings, to help users learn more about managing symptoms and improving their functioning. After 12 months of app use, an interview will be conducted to gather feedback about their experiences with the app. The information collected from these interviews will be analyzed to further enhance and improve the app's functionality.

Timeline

• Start date: 2025-08-24
• Primary completion: 2029-10-01
• Completion: 2030-11-01
• First posted: 2024-10-21
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States