Cleveland African American Prostate Cancer Project: Equivalence of Passive Navigation, Active Navigation, and Community-based Screening for Completion of Prostate Cancer Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- PSA Screening Test
Study Overview
Brief Summary
The purpose of this research is to test intervention strategies that encourage and support Black or African American men who are 40 and older to complete prostate cancer screening, and specifically to complete a prostate-specific antigen (PSA) test.
Detailed Description
This intervention is designed to evaluate the effectiveness of three different approaches to increasing PSA screening in African American men, starting at age 40. The approaches are 1) education and passive navigation, 2) education and active navigation, and 3) education and active navigation with community based outreach. Completion of a PSA blood test is the primary outcome of this study, which will be evaluated four months following the recruitment phase at each shop. At the 4 month follow-up, participants will be asked about PSA completion; participants who completed PSA screening will be asked to provide outcomes from their PSA screening (ie. PSA results and provider recommended next steps), as well as their feelings regarding their screening experience, trust in the screening process, and knowledge about prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Masking Description
The data analyst will be blinded to the study arm assignments.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •≥40 years old
- •Self-identify as Black or African American
- •Have a prostate gland (includes biological males, transwomen)
- •PSA-naïve or has not received a PSA test in the past 12 months
- •Has not had a previous prostate cancer diagnosis
- •English speaking
- •Ability to consent to study
Exclusion Criteria
- •Individuals who have had a prostatectomy
Arms & Interventions
Education and Active Navigation with Community Based Outreach
This arm adds the community navigator and a community outreach screening event. Case Comprehensive Cancer Center Community Outreach and Engagement will offer barber shops an onsite PSA screening event.
Intervention: Education by Community Navigator (Behavioral)
Education and Active Navigation with Community Based Outreach
This arm adds the community navigator and a community outreach screening event. Case Comprehensive Cancer Center Community Outreach and Engagement will offer barber shops an onsite PSA screening event.
Intervention: Education at Community Outreach Screening Event (Behavioral)
Education and Active Navigation
This arm includes all interventions of the first arm plus the addition of a community navigator. The community navigator will be onsite to assist in information delivery and navigation to resources and encourage the completion of the Screener through the QR code. The community navigator will help participants connect with a primary care provider to continue with all preventive healthcare recommendations.
Intervention: Education by Community Navigator (Behavioral)
Education and Passive Navigation
This arm receives barber-led education and access to a resource website. Barbers will encourage clients to access the screening website. Other study materials will also be located within the shop. The resource website will be accessible via QR code that will encourage potential participants to complete a Prostate Cancer Knowledge and Risk Assessment questionnaire.
Intervention: Passive Education (Behavioral)
Education and Active Navigation
This arm includes all interventions of the first arm plus the addition of a community navigator. The community navigator will be onsite to assist in information delivery and navigation to resources and encourage the completion of the Screener through the QR code. The community navigator will help participants connect with a primary care provider to continue with all preventive healthcare recommendations.
Intervention: Passive Education (Behavioral)
Education and Active Navigation with Community Based Outreach
This arm adds the community navigator and a community outreach screening event. Case Comprehensive Cancer Center Community Outreach and Engagement will offer barber shops an onsite PSA screening event.
Intervention: Passive Education (Behavioral)
Outcomes
Primary Outcomes
PSA Screening Test
Time Frame: At 4 months
The number of participants who had a PSA screening test completed.
Secondary Outcomes
- Primary Care Physician Visit(At 14 months)
- PSA Screening Test(At 14 months)
- Primary Care Physician Visit(At 4 months)