Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PC230551 | Other Grant/Funding Number | DoD CDMRP PCRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
Not provided
Not provided
Inclusion Criteria:
- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Motolani Adedipe, PhD, DPh, MS | Contact | (405)-271-8001 | 50520 | Motolani-adedipe@ouhsc.edu |
| Parisa Ghasemi, MD | Contact | (405) 271-8001 | 50491 | parisa-ghasemi@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Motolani Adedipe, PhD, DPh, MS | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306-4310 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41875429 | Derived | 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. |
| Label | URL |
|---|---|
| A Culturally Tailored Mobile Health Intervention to Improve Quality of Life in Black Prostate Cancer Survivors: Protocol for a Stratified Randomized Controlled Trial | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Georgia College & State University | Recruiting | Milledgeville | Georgia | 31061 | United States |
|
| University of Oklahoma HSC | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |