Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06651359

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Tallahassee, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born

Exclusion criteria

  • Men from other races.
  • Men who have never been diagnosed with CaP
  • Men who have the inability to speak English

Treatment and study plan

Surveys for Quality of Life

Behavioral

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).

Surveys and mHealth App access

Behavioral

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.

Primary outcomes

  1. Overall Quality of Life (QoL) assessment in Black men with prostate cancer

    Time frame: 12 months

    The proportion of patients in the intervention arm reporting increased QoL using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) survey.

    FACT-P has five subscales:

    • Physical Well-Being- Evaluate symptoms like pain and energy.
    • Social/Family Well-Being- Measures support and communication satisfaction.
    • Emotional Well-Being- Assesses sadness, anxiety, coping, and hope.
    • Functional Well-Being- Measures daily activities, contentment, and enjoyment.
    • Prostate Cancer Subscale- Addresses symptoms like sexual function, pain, and urinary issues.

    Higher scores indicating better QoL overall. FACT-P captures physical, social, emotional, functional, and prostate-specific well-being to measure comprehensive patient outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Motolani Adedipe, PhD, DPh, MS

CONTACT

[email protected]

(405)-271-8001 ext. 50520

Parisa Ghasemi, MD

CONTACT

[email protected]

(405) 271-8001 ext. 50491

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Oct 21, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.