Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05469269

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

Interventions

Passive Education

Education by Community Navigator

Education at Community Outreach Screening Event

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT05469269

Start date

Jun 9, 2023

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Oct 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Passive Education

Education: QR codes will be posted at each barber's station within a barber shop, as well as on other study materials located within the shop. The QR code recruitment mechanism will encourage potential participants to complete a Prostate Cancer Knowledge and Risk Assessment questionnaire (ie. Screener) which acts as a screener for study eligibility. The screener can be completed by scanning the QR code with a cell phone while in the barbershop. Barbers will encourage their clients to complete the Screener.

Education by Community Navigator

A community navigator will be onsite to assist in information delivery, navigation to resources, and encourage the completion of the Screener through the QR code. Participants can opt to connect with the community navigator if they have questions, need assistance in scheduling a PSA screening, or if they have other resource needs. The community navigator will help participants connect with a primary care provider to continue with all preventive healthcare recommendations.

Education at Community Outreach Screening Event

The Community Navigator will set up PSA screening events at specific barber shops for participants who wish to move forward with screenings.

Primary outcome measure

  • PSA Screening Test [ Time Frame: At 4 months ]

Central Contacts and Locations

Central contacts

Erika Trapl, PhD

216-368-8772CAAPP@case.edu

Locations

Barbershops Local to Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-04-08.