Prostate CancerNCT07055165
Connect2Care: Prostate Cancer Education and Screenings 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 tool for prostate cancer, however, knowledge about prostate cancer and screening benefits and risks and uptake of PSA… Read more about this study
- Who is it for?
- Ages 45 to 69 years, men only
- 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
- 466 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2025to Dec 2026
- Phase
- Interventional
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 45 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Live in Oklahoma
- Self-identify as Black/African American
- Self-identify as male
- Between ages 45-69
- Not currently diagnosed with prostate cancer
Who cannot join
- Participants will be excluded if they are not interested in using a phone app for 30 days
- Has taken a PSA test or has completed PSA screening within the past two years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
Jan Foisy
Jordan Neil, PhD
About this study
Official title: Connect2Care: A Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Screenings 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 tool for prostate cancer, however, knowledge about prostate cancer and screening benefits and risks and uptake of PSA screening remains low among African American men. To address this inequity, this project proposes the use of the Connect2Care App to improve knowledge of prostate cancer, screening benefits, risks and increase readiness to complete a PSA test (e.g., intentions, motivation, confidence, and self-efficacy). The primary goal of this study is to evaluate the efficacy of the Connect2Care App in a 30-day randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men between the ages of 45 and 69 from Oklahoma (N = 266), who are not up to date with PSA screening according to recommended guidelines, will be randomly assigned 1:1 to receive either app. The app feasibility will be assessed: (1) efficacy, evaluated via post-intervention differences in knowledge of prostate cancer, screening benefits and risks, (2) app engagement and accessibility, measured via self-report validated questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. We will explore readiness to complete a PSA test and identify predictors of readiness across both study arms. The successful demonstration of the feasibility of the Connect2Care App among African American men living in Oklahoma will support expanding this intervention to African American men 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. The prostate-specific antigen (PSA) test is an early detection screening tool for prostate cancer, however, knowledge about prostate cancer and screening benefits and risks and uptake of PSA screening remains low among African American men. To address this inequity, this project proposes the use of the Connect2Care App to improve knowledge of prostate cancer, screening benefits, risks and increase readiness to complete a PSA test (e.g., intentions, motivation, confidence, and self-efficacy). The primary goal of this study is to evaluate the efficacy of the Connect2Care App in a 30-day randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men between the ages of 45 and 69 from Oklahoma (N = 266), who are not up to date with PSA screening according to recommended guidelines, will be randomly assigned 1:1 to receive either app. The app feasibility will be assessed: (1) efficacy, evaluated via post-intervention differences in knowledge of prostate cancer, screening benefits and risks, (2) app engagement and accessibility, measured via self-report validated questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. We will explore readiness to complete a PSA test and identify predictors of readiness across both study arms. The successful demonstration of the feasibility of the Connect2Care App among African American men living in Oklahoma will support expanding this intervention to African American men nationwide.
- Specific Aims
The overall objectives of this proposal are to: (1) address two key SDOH (i.e., neighborhood and built environment and access to high-quality preventive care); (2) leverage community and individual levels of influence; and (3) implement a social risk screener and social needs referral process, at both community and individual levels, that mitigates significant barriers to PSA screening and timely follow-up care. Our central hypothesis is that combining a traditional community-engaged research intervention with an innovative smartphone app navigation intervention, while providing access to free PSA screening tests and follow-up care at Stephenson Cancer Center (see Letter of Support), will have a meaningful impact on prostate cancer outcomes among AA men in Oklahoma. This hypothesis has been formulated based on our promising pilot data (see Preliminary Studies). To attain our overall objectives, we will recruit a total of 466 AA men, aged 55-69 and not up to date with PSA screening. As such, the following specific aims are proposed:
Aim 1. Conduct a multimodal community outreach intervention to improve awareness of and access to PSA screening. Approach. The intervention will include (1) a culturally tailored Social Media Campaign, geofenced to counties with the greatest AA prostate cancer incidence. Participants who click on the campaign can order a free at-home PSA test. (2) In-person Community Health Events will provide educational information and access to on-site PSA screening via our mobile screening vans. A total of 200 AA men will be accrued across both outreach methods. Outcomes. Awareness will be measured by the reach and penetration of the interventions and access by the number of completed PSA screening tests.
Aim 2. Determine the efficacy of smartphone intervention on at-home PSA screening rates. Approach. A total of 266 AA men will be randomized to a two-arm RCT for 4 weeks. Intervention arms include US Preventive Services Task Force App (control) vs. Prostate Cancer Genius App (Genius App; intervention). In both arms, participants will receive information about prostate cancer and screening, have access to a free at-home PSA test and free follow-up care, and social needs referrals. Participants in the Genius App will also have access to several culturally tailored, novel features to support at-home PSA screening. Outcomes. Efficacy (primary outcome) is determined by PSA screening rates 30 days post-randomization.
Aim 3. Explore the feasibility and acceptability of a social risk screening tool to connect participants to social needs referral services. Approach. After completing a baseline social risk screener, all participants will receive some form of navigation for social needs referral. Navigation will differ by type and intensity. Participants accrued by community outreach will receive One-Time Navigation via a list of referral resources, tailored to their social needs assessment and geography. Participants enrolled in the smartphone intervention will receive Weekly Navigation, which provides more intensive support via a study navigator and geofenced social needs notifications on their study app. Outcomes. Feasibility will be measured by the percentage of participants who complete a social risk screener, and the percentage connected to a referral service. Acceptability will be assessed via qualitative exit interviews (N=80), stratified by social need (high vs. low).
- Conditions
- Prostate Cancer, Health Behavior
- Being tested
- Prostate Cancer Genius App, US Prevention Taskforce App
- Medical subject headings
- Prostatic Neoplasms, Health Behavior
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 |
|---|---|---|
| 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.
Awareness
Awareness will be measured by reach and penetration of the intervention. For the Social Media Campaign, reach will be determined by the percentage of participants who successfully engage with intervention and will be calculated by the number of impressions (i.e., number of times adverts are seen) divided by the number of times participants engaged with the intervention (i.e., click through rate). This will determine a click through rate, which can be calculated per study ad and geographic region. For the Community Health Events, reach will be determined by the number of events hosted and the number of participants who attend. Penetration will also be explored through a geographic informational systems (GIS) analysis to better understand whether spatial (e.g., distance to CHCO sites) and/or participant-level characteristics (e.g., age) were associated with greater likelihood to engage with the intervention (both Social Media Campaign and Community Health Events) and/or complete a PSA.
Measured: 30 Days
Secondary outcomes (1)
Access
Access will be measured by the number of PSA tests completed. The pre- and post-test surveys will assess sociodemographic characteristics, knowledge, attitudes and beliefs about prostate cancer and readiness to screen
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 posted8 Jul 2025
- Study start26 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Neil, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055165
- Sponsor's protocol ID
- 18003
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No