Connect2Care: A Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Screenings for African American Men
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.
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.
A. 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).
Inclusion Criteria:
Exclusion Criteria:
jordan-neil@ouhsc.edu(405) 271-5046
adam-alexander@ouhsc.edu(405) 271-5046