Prostate Cancer
Conditions
Keywords
mHealth, Black men, Black survivors, native-born Black man, African-born Black man, Caribbeanborn Black man
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.
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.
Interventions
BEHAVIORALSurveys 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).
BEHAVIORALSurveys 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.
Sponsors
University of Oklahoma
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Life (QoL) assessment in Black men with prostate cancer | 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. |
Countries
United States
Contacts
CONTACTMotolani Adedipe, PhD, DPh, MS
CONTACTParisa Ghasemi, MD
PRINCIPAL_INVESTIGATORMotolani Adedipe, PhD, DPh, MS
University of Oklahoma
Outcome results
None listed