NCT06651359 · University of Oklahoma
Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tallahassee, Florida
- Milledgeville, Georgia
- Oklahoma City, Oklahoma
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations