Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors

NCT ID: NCT06651359

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-24

Study Completion Date

2030-11-30

Brief Summary

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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

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors.

Group Type OTHER

Surveys for Quality of Life

Intervention Type 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).

Intervention group

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.

Group Type EXPERIMENTAL

Surveys for Quality of Life

Intervention Type 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).

Surveys and mHealth App access

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born, within the early phase of their CaP survivorship journey (defined as within the first five years after diagnosis).

Exclusion Criteria

* Men from other races.
* Men who have never been diagnosed with CaP
* Men who have the inability to speak English
* Men who do not own a smartphone
* Black CaP survivors who are over 5 years since the time of diagnosis
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Motolani Adedipe, PhD, DPh, MS

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status RECRUITING

Georgia College & State University

Milledgeville, Georgia, United States

Site Status RECRUITING

University of Oklahoma HSC

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Motolani Adedipe, PhD, DPh, MS

Role: CONTACT

(405)-271-8001 ext. 50520

Facility Contacts

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Sabrina Dickey, PhD, RN

Role: primary

Ernie Kaninjing, DrPH

Role: primary

Motolani Adedipe, PhD, DPh, MS

Role: primary

Other Identifiers

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PC230551

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OU202403MA-MHEALTH

Identifier Type: -

Identifier Source: org_study_id

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