Cleveland African American Prostate Cancer Project

Clinicaltrials.gov ID: NCT05469269
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 40 Years
b-bullseye-arrow Enrollments 800

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Erika Trapl, PhD

Eligibility Criteria

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 Plan

Education and Passive Navigation

EXPERIMENTAL

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.

  • BEHAVIORAL:

    Passive Education

    Description:

    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

EXPERIMENTAL

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.

  • BEHAVIORAL:

    Passive Education

    Description:

    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.
  • BEHAVIORAL:

    Education by Community Navigator

    Description:

    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

EXPERIMENTAL

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.

  • BEHAVIORAL:

    Passive Education

    Description:

    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.
  • BEHAVIORAL:

    Education by Community Navigator

    Description:

    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.
  • BEHAVIORAL:

    Education at Community Outreach Screening Event

    Description:

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

Outcome Measures

Primary Outcome Measures

PSA Screening Test

Time Frame: At 4 months

Secondary Outcome Measures

PSA Screening Test

Time Frame: At 14 months

Primary Care Physician Visit

Time Frame: At 4 months

Primary Care Physician Visit

Time Frame: At 14 months

Timeline

  • Last Updated
    May 10, 2024
  • Start Date
    July 21, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    March 31, 2027

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