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)
2 other identifiers
interventional
248
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Aug 2025
Typical duration for not_applicable prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
August 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
April 1, 2026
March 1, 2026
4.1 years
October 17, 2024
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Quality of Life (QoL) assessment in Black men with prostate cancer
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: 1. Physical Well-Being- Evaluate symptoms like pain and energy. 2. Social/Family Well-Being- Measures support and communication satisfaction. 3. Emotional Well-Being- Assesses sadness, anxiety, coping, and hope. 4. Functional Well-Being- Measures daily activities, contentment, and enjoyment. 5. 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.
12 months
Study Arms (2)
Control group
OTHERParticipants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors.
Intervention group
EXPERIMENTALParticipants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors, who are given access to the mHealth app for this study.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- \- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born
You may not qualify if:
- Men from other races.
- Men who have never been diagnosed with CaP
- Men who have the inability to speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- United States Department of Defensecollaborator
Study Sites (3)
Florida State University
Tallahassee, Florida, 32306-4310, United States
Georgia College & State University
Milledgeville, Georgia, 31061, United States
University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
Kumar G, Ghasemi P, Alexander AC, Dwyer K, Neil JM, Cole P, Beckford P, Reese D, Montgomery E, Odeleye R, Harris MA, Zhao YD, Nagykaldi Z, McIntosh AG, Kaninjing E, Young ME, Dickey S, Morton DJ, Bolajoko O, Odedina FT, Planas LG, Businelle MS, Kendzor DE, Ogunsanya ME. A Culturally Tailored Mobile Health Intervention to Improve Quality of Life in Black Survivors With Prostate Cancer: Protocol for a Stratified Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 24;15:e81503. doi: 10.2196/81503.
PMID: 41875429DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Motolani Adedipe, PhD, DPh, MS
University of Oklahoma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 21, 2024
Study Start
August 24, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
November 1, 2030
Last Updated
April 1, 2026
Record last verified: 2026-03