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Trial Title:
Using a mHealth App to Improve Quality-of-Life Outcomes in Black Prostate Cancer Survivors
NCT ID:
NCT06651359
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
mHealth
Black men
Black survivors
native-born Black man
African-born Black man
Caribbeanborn Black man
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Surveys for Quality of Life
Description:
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).
Arm group label:
Control group
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Surveys and mHealth App access
Description:
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.
Arm group label:
Intervention group
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida State University
Address:
City:
Tallahassee
Zip:
32306-4310
Country:
United States
Contact:
Last name:
Sabrina Dickey, PhD, RN
Investigator:
Last name:
Sabrina Dickey, PhD, RN
Email:
Sub-Investigator
Facility:
Name:
Georgia College & State University
Address:
City:
Milledgeville
Zip:
31061
Country:
United States
Contact:
Last name:
Ernie Kaninjing, DrPH
Investigator:
Last name:
Ernie Kaninjing, DrPH
Email:
Sub-Investigator
Facility:
Name:
University of Oklahoma HSC
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Contact:
Last name:
Motolani Adedipe, PhD, DPh, MS
Email:
Motolani-adedipe@ouhsc.edu
Investigator:
Last name:
Motolani Adedipe
Email:
Principal Investigator
Start date:
November 2024
Completion date:
December 2028
Lead sponsor:
Agency:
University of Oklahoma
Agency class:
Other
Source:
University of Oklahoma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06651359
