Cleveland African American Prostate Cancer Project

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: Passive Education; Behavioral: Education at Community Outreach Screening Event; Behavioral: Education by Community Navigator

Study type: Interventional

Funder types: Other

Identifiers

NCT05469269

CASE7822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 3 patient groups

Education and Passive Navigation

Experimental group

Description:

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.

Treatment:

Behavioral: Passive Education

Education and Active Navigation

Experimental group

Description:

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.

Treatment:

Behavioral: Passive Education

Behavioral: Education by Community Navigator

Education and Active Navigation with Community Based Outreach

Experimental group

Description:

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.

Treatment:

Behavioral: Passive Education

Behavioral: Education by Community Navigator

Behavioral: Education at Community Outreach Screening Event