Prostate CancerNCT06651359
Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors
A study testing Surveys for Quality of Life and Surveys and mHealth App access in people with Prostate Cancer, run by University of Oklahoma at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Surveys for Quality of Life and Surveys and mHealth App access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Aug 2025to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born
Who cannot join
- Men from other races.
- Men who have never been diagnosed with CaP
- Men who have the inability to speak English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Georgia College & State University
Milledgeville, Georgia, 31061
Ernie Kaninjing, DrPH
Ernie Kaninjing, DrPH
- Recruiting
University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104
Motolani Adedipe, PhD, DPh, MS, Motolani-adedipe@ouhsc.edu
Motolani Adedipe
- Recruiting
Florida State University
Tallahassee, Florida, 32306-4310
Sabrina Dickey, PhD, RN
Sabrina Dickey, PhD, RN
About this study
Official 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)
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.
Read the 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
- Being tested
- Surveys for Quality of Life, Surveys and mHealth App access
- Keywords
- mHealth, Black men, Black survivors, native-born Black man, African-born Black man, Caribbeanborn Black man
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveys for Quality of LifeBehavioural
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 accessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors. Receives: Behavioral: Surveys for Quality of Life |
| Intervention group | Experimental | Participants 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. Receives: Behavioral: Surveys for Quality of Life; Behavioral: Surveys and mHealth App access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start24 Aug 2025
- Primary completionOct 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Motolani Adedipe, PhD, DPh, MS, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651359
- Sponsor's protocol ID
- OU202403MA-MHEALTH
- Other IDs
- PC230551
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41875429
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06651359
- Acronym / sponsor ID
- OU202403MA-MHEALTH
- Conditions
- Prostate Cancer
- Keywords
- mHealth, Black men, Black survivors, native-born Black man, African-born Black man, Caribbeanborn Black man
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 24 Aug 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: Surveys for Quality of LifeParticipants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors. |
| Intervention group | Experimental | Behavioral: Surveys for Quality of Life, Behavioral: Surveys and mHealth App accessParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born
Key exclusion criteria (3 listed)
- Men from other races.
- Men who have never been diagnosed with CaP
- Men who have the inability to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surveys for Quality of LifeThis 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). | Behavioural | Control group, Intervention group |
| Surveys and mHealth App accessThis 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. | Behavioural | Intervention group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 41875429Kumar 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.
- A Culturally Tailored Mobile Health Intervention to Improve Quality of Life in Black Prostate Cancer Survivors: Protocol for a Stratified Randomized Controlled TrialLink provided by the sponsor.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Motolani Adedipe, PhD, DPh, MS principal investigator
University of Oklahoma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys for Quality of Life and Surveys and mHealth App access in people with Prostate Cancer, run by University of Oklahoma at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Motolani Adedipe, PhD, DPh, MS ((405)-271-8001 ext. 50520, Motolani-adedipe@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Quality of Life (QoL) assessment in Black men with prostate cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.