Clinical trial NCT06651359: Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: mHealth
Black men
Black survivors
native-born Black man
African-born Black man
Caribbeanborn Black man
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 248
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Quality of Life (QoL) assessment in Black men with prostate cancer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Milledgeville
country: United States
facility: Georgia College & State University
state: Georgia
city: Oklahoma City
country: United States
facility: University of Oklahoma HSC
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Motolani Adedipe, PhD, DPh, MS
role: PRINCIPAL_INVESTIGATOR
References: