Cleveland African American Prostate Cancer Project

NCT ID: NCT05469269

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
The data analyst will be blinded to the study arm assignments.

Study Groups

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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.

Group Type EXPERIMENTAL

Passive Education

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Passive Education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Passive Education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erika Trapl, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

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Barbershops Local to Cleveland

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erika Trapl, PhD

Role: CONTACT

Phone: 216-368-8772

Email: [email protected]

Other Identifiers

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CASE7822

Identifier Type: -

Identifier Source: org_study_id