Prostate CancerPCGANCT05331638
Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men
A study testing Prostate Cancer Genius App and US Prevention Taskforce App in people with Prostate Cancer and Health Behavior, run by University of Oklahoma at 1 site in United States.
Trial summary
Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Read more about this study
- Who is it for?
- Ages 55 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Health Behavior
- What is being tested?
- Prostate Cancer Genius App and US Prevention Taskforce App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- live in Oklahoma
- self-identify as "male" and "Black or African American"
- are between the ages of 55 and 69
- have not completed PSA screening within the past two years.
Who cannot join
- Currently or previously diagnosed with prostate cancer ;
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Pilot Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Home-based PSA Screening for African American Men
Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. To address this inequity, innovative team science approaches are required. This project proposes to develop and test the first-of-its-kind Prostate Cancer Genius App to improve knowledge of prostate cancer risk and symptoms, and deliver tailored navigation to complete a home-based PSA test. The primary goal of this study is to evaluate the feasibility of the Prostate Cancer Genius App in a 30-day pilot randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men from Oklahoma, aged between 55 and 69 (N = 80), eligible for the PSA test will be randomly assigned 1:1 to receive either app. Three dimensions of app feasibility will be assessed: (1) preliminary efficacy, evaluated via post-intervention differences in prostate cancer knowledge, (2) app engagement and accessibility, measured via self-report questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. Finally, the investigative team will explore post-intervention PSA screening rates and identify predictors of screening/not screening across both arms. The successful demonstration of feasibility for the Prostate Cancer Genius App within Oklahoma will support expanding this intervention to African Americans nationwide.
Read the detailed description
Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. Disparities in prostate cancer for African American men have persisted for almost half a century, and these health disparities are among the most extreme of all cancers in the United States. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. The process of informed and effective decision-making is heavily underpinned by adequate knowledge levels of the disease and screening benefits and risks, with lower knowledge levels reported among African American men. This project will test the feasibility of a first-of-its-kind Prostate Cancer Genius App (herein referred to as Genius App) to improve knowledge of prostate cancer risk and symptoms. PSA testing is not appropriate for all men, so the Genius App will support informed decision-making with a healthcare provider. The Genius App will also provide novel tailored navigation to complete a home-based PSA test for men who opt to screen. To test the app, 80 African American men from Oklahoma (aged 55 and 69) who are not up to date with PSA screening will be randomly assigned 1:1 to use either the Genius app or an existing U.S. Department of Health \& Human Services app (herein referred to as the Prevention Taskforce App) for 30 days.
Aim 1. Evaluate the preliminary efficacy of a prostate cancer prevention app on prostate cancer knowledge (primary outcome).
Hypothesis: Participants (n = 40) randomly assigned to the Genius app will report significantly greater knowledge about prostate cancer post-intervention than participants (n = 40) randomly assigned to the Prevention Taskforce app at 30 days post-randomization.
Aim 2. Explore the perceived engagement, accessibility, and acceptability of a prostate cancer prevention app.
The investigative team will explore: (i) the extent to which participants find the Genius App engaging and accessible compared to the Prevention Taskforce app via validated self-report questionnaires and app metadata; and (ii) the perceived acceptability of the Genius App by conducting semi-structured interviews (n=40) with participants to acquire in-depth descriptions of their experiences with the app at the end of the study.
Aim 3. Derive preliminary estimates of the effects of a Genius App on PSA screening test completion rates and identify mechanisms of screening adherence.
The investigative team will (i) explore differences in PSA test completion rates, including in-clinic and home-based PSA testing, between the Genius app and the Prevention Taskforce app and (ii) identify whether changes in key variables in weekly smartphone assessments predict completing a PSA test.
- Conditions
- Prostate Cancer, Health Behavior
- Being tested
- Prostate Cancer Genius App, US Prevention Taskforce App
- Keywords
- Prostate cancer, African American, mHealth, randomized clinical trial, health disparity, PSA Test, smartphone, cancer, education
- Medical subject headings
- Prostatic Neoplasms, Health Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Cancer Genius AppBehavioural
Participants assigned to use the Prostate Cancer Genius App will receive a combination of (a) scheduled and (b) on-demand content prostate cancer for one month. Scheduled content will be delivered on specific days each week using app notifications. Participants will also receive tailored navigation for ordering a home-based PSA kit, including receiving follow-up information from trained medical professionals about their test results.
US Prevention Taskforce AppBehavioural
Participants assigned to use the US Prevention Task Force app will download the app from Google Play and will be instructed to use the app for one-month to to become more informed about prostate cancer. They will also be instructed to download a companion app from the Google Play store. This companion app will be used to deliver weekly assessments and order a home-based PSA test kit if the participant chooses to so. Participants assigned to the Prevention Taskforce app will receive a brochure providing details about the purpose of the home-based PSA test.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Genius app | Experimental | The Prostate Cancer Genius app includes the following components: (1) educational content that is consistent with existing evidence and recommendations for prostate cancer and prostate cancer screening but has been adapted for the African American male population and for adults who read at or below the 8th-grade level; (2) real-time messages about the risks of prostate cancer and the benefits of completing a PSA test, placing a special emphasis on screening considerations for individuals with a family history of prostate cancer and/or lower urinary tract symptoms (measured via the American Urological Association Symptom Score); (3) general trivia that also incorporates quiz questions about prostate cancer and the PSA test; (4) African American-specific testimonials and educational videos; (5) optional counseling by African American prostate cancer survivors; and (6) on-demand, automated ordering of a home-based PSA test. Receives: Behavioral: Prostate Cancer Genius App |
| Prevention Taskforce app | Active comparator | The Prevention Taskforce app provides on-demand access to evidence-based recommendations for prostate cancer for men between 55 and 69 (i.e., it can be accessed as needed). Receives: Behavioral: US Prevention Taskforce App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer Knowledge
All participants will complete a baseline survey and a post-intervention survey via REDCap. Baseline and post-intervention assessments will measure prostate cancer risk and screening knowledge using the Prostate Cancer Knowledge Scale.The scale consists of 18 items that assess screening (6 items), risk factors (5 items), and warning signs (7 items) of prostate cancer. This scale has strong internal consistency (α = .80) and has been validated for use in the African American population.
Measured: 30-days
Secondary outcomes (1)
PSA screening test completion rates
Home-based PSA test completion rates will be analyzed four weeks after enrollment via documented receipt of the kit. We will also measure the number of participants who (a) scheduled a visit with their provider, (b) reported shared decision making with their provider, and (c) self-report completing a clinic-based PSA test. To verify, participants will have the option to upload a copy of their results to verify self-report data.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start24 Feb 2023
- Primary completion9 Sep 2024
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Alexander, PhD, Principal investigator, TSET Health Promotion Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331638
- Sponsor's protocol ID
- PCGA2022
- Acronym
- PCGA
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neil J, Mao B, Shao R, Motolani E Ogunsanya, Frank-Pearce S, Businelle M, Cookson M, Stratton K, Doescher M, Pharr S, Moise V, Fleshman B, Fronheiser J, Estrada K, Flores I, Bradley D, Kendrick A, Alexander AC. A pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol. Contemp Clin Trials. 2024 Dec;147:107737. doi: 10.1016/j.cct.2024.107737. Epub 2024 Nov 10.
PubMed 39532237
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Home-based PSA Screening for African American Men
- ClinicalTrials.gov ID
- NCT05331638
- Acronym / sponsor ID
- PCGA / PCGA2022
- Conditions
- Prostate Cancer, Health Behavior
- Keywords
- Prostate cancer, African American, mHealth, randomized clinical trial, health disparity, PSA Test, smartphone, cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. To address this inequity, innovative team science approaches are required. This project proposes to develop and test the first-of-its-kind Prostate Cancer Genius App to improve knowledge of prostate cancer risk and symptoms, and deliver tailored navigation to complete a home-based PSA test. The primary goal of this study is to evaluate the feasibility of the Prostate Cancer Genius App in a 30-day pilot randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men from Oklahoma, aged between 55 and 69 (N = 80), eligible for the PSA test will be randomly assigned 1:1 to receive either app. Three dimensions of app feasibility will be assessed: (1) preliminary efficacy, evaluated via post-intervention differences in prostate cancer knowledge, (2) app engagement and accessibility, measured via self-report questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. Finally, the investigative team will explore post-intervention PSA screening rates and identify predictors of screening/not screening across both arms. The successful demonstration of feasibility for the Prostate Cancer Genius App within Oklahoma will support expanding this intervention to African Americans nationwide.
Detailed description
Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. Disparities in prostate cancer for African American men have persisted for almost half a century, and these health disparities are among the most extreme of all cancers in the United States. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. The process of informed and effective decision-making is heavily underpinned by adequate knowledge levels of the disease and screening benefits and risks, with lower knowledge levels reported among African American men. This project will test the feasibility of a first-of-its-kind Prostate Cancer Genius App (herein referred to as Genius App) to improve knowledge of prostate cancer risk and symptoms. PSA testing is not appropriate for all men, so the Genius App will support informed decision-making with a healthcare provider. The Genius App will also provide novel tailored navigation to complete a home-based PSA test for men who opt to screen. To test the app, 80 African American men from Oklahoma (aged 55 and 69) who are not up to date with PSA screening will be randomly assigned 1:1 to use either the Genius app or an existing U.S. Department of Health \& Human Services app (herein referred to as the Prevention Taskforce App) for 30 days.
Aim 1. Evaluate the preliminary efficacy of a prostate cancer prevention app on prostate cancer knowledge (primary outcome).
Hypothesis: Participants (n = 40) randomly assigned to the Genius app will report significantly greater knowledge about prostate cancer post-intervention than participants (n = 40) randomly assigned to the Prevention Taskforce app at 30 days post-randomization.
Aim 2. Explore the perceived engagement, accessibility, and acceptability of a prostate cancer prevention app.
The investigative team will explore: (i) the extent to which participants find the Genius App engaging and accessible compared to the Prevention Taskforce app via validated self-report questionnaires and app metadata; and (ii) the perceived acceptability of the Genius App by conducting semi-structured interviews (n=40) with participants to acquire in-depth descriptions of their experiences with the app at the end of the study.
Aim 3. Derive preliminary estimates of the effects of a Genius App on PSA screening test completion rates and identify mechanisms of screening adherence.
The investigative team will (i) explore differences in PSA test completion rates, including in-clinic and home-based PSA testing, between the Genius app and the Prevention Taskforce app and (ii) identify whether changes in key variables in weekly smartphone assessments predict completing a PSA test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Genius app | Experimental | Behavioral: Prostate Cancer Genius AppThe Prostate Cancer Genius app includes the following components: (1) educational content that is consistent with existing evidence and recommendations for prostate cancer and prostate cancer screening but has been adapted for the African American male population and for adults who read at or below the 8th-grade level; (2) real-time messages about the risks of prostate cancer and the benefits of completing a PSA test, placing a special emphasis on screening considerations for individuals with a family history of prostate cancer and/or lower urinary tract symptoms (measured via the American Urological Association Symptom Score); (3) general trivia that also incorporates quiz questions about prostate cancer and the PSA test; (4) African American-specific testimonials and educational videos; (5) optional counseling by African American prostate cancer survivors; and (6) on-demand, automated ordering of a home-based PSA test. |
| Prevention Taskforce app | Active comparator | Behavioral: US Prevention Taskforce AppThe Prevention Taskforce app provides on-demand access to evidence-based recommendations for prostate cancer for men between 55 and 69 (i.e., it can be accessed as needed). |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- live in Oklahoma
- self-identify as "male" and "Black or African American"
- are between the ages of 55 and 69
- have not completed PSA screening within the past two years.
Key exclusion criteria (1 listed)
- Currently or previously diagnosed with prostate cancer ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Cancer Genius AppParticipants assigned to use the Prostate Cancer Genius App will receive a combination of (a) scheduled and (b) on-demand content prostate cancer for one month. Scheduled content will be delivered on specific days each week using app notifications. Participants will also receive tailored navigation for ordering a home-based PSA kit, including receiving follow-up information from trained medical professionals about their test results. | Behavioural | Prostate Cancer Genius app |
| US Prevention Taskforce AppParticipants assigned to use the US Prevention Task Force app will download the app from Google Play and will be instructed to use the app for one-month to to become more informed about prostate cancer. They will also be instructed to download a companion app from the Google Play store. This companion app will be used to deliver weekly assessments and order a home-based PSA test kit if the participant chooses to so. Participants assigned to the Prevention Taskforce app will receive a brochure providing details about the purpose of the home-based PSA test. | Behavioural | Prevention Taskforce app |
Primary outcome
Prostate Cancer Knowledge
Time frame: 30-days
All participants will complete a baseline survey and a post-intervention survey via REDCap. Baseline and post-intervention assessments will measure prostate cancer risk and screening knowledge using the Prostate Cancer Knowledge Scale.The scale consists of 18 items that assess screening (6 items), risk factors (5 items), and warning signs (7 items) of prostate cancer. This scale has strong internal consistency (α = .80) and has been validated for use in the African American population.
1 secondary outcome
PSA screening test completion rates
Time frame: 30-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 39532237Neil J, Mao B, Shao R, Motolani E Ogunsanya, Frank-Pearce S, Businelle M, Cookson M, Stratton K, Doescher M, Pharr S, Moise V, Fleshman B, Fronheiser J, Estrada K, Flores I, Bradley D, Kendrick A, Alexander AC. A pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol. Contemp Clin Trials. 2024 Dec;147:107737. doi: 10.1016/j.cct.2024.107737. Epub 2024 Nov 10.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Alexander, PhD principal investigator
TSET Health Promotion Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Cancer Genius App and US Prevention Taskforce App in people with Prostate Cancer and Health Behavior, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Knowledge (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.