Cleveland African American Prostate Cancer Project

Prostate Cancer Clinical Trial

Official title:

Cleveland African American Prostate Cancer Project: Equivalence of Passive Navigation, Active Navigation, and Community-based Screening for Completion of Prostate Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469269
• Other study ID #: CASE7822
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: October 2023
• Source: Case Comprehensive Cancer Center
• Contact: Erika Trapl, PhD
• Phone: 216-368-8772
• Email: CAAPP[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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
• English speaking
• Ability to consent to study

Exclusion Criteria:

• Individuals who have had a prostatectomy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Barbershops Local to Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Screening Test	The number of participants who had a PSA screening test completed.	At 4 months
Secondary	PSA Screening Test	The number of participants who had a PSA screening test completed.	At 14 months
Secondary	Primary Care Physician Visit	The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.	At 4 months
Secondary	Primary Care Physician Visit	The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.	At 14 months