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Cleveland African American Prostate Cancer Project

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive Education
Education by Community Navigator
Education at Community Outreach Screening Event
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleAccepts 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
  • English speaking
  • Ability to consent to study

Exclusion Criteria:

  • Individuals who have had a prostatectomy

Sites / Locations

  • Barbershops Local to ClevelandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Education and Passive Navigation

Education and Active Navigation

Education and Active Navigation with Community Based Outreach

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

PSA Screening Test
The number of participants who had a PSA screening test completed.

Secondary Outcome Measures

PSA Screening Test
The number of participants who had a PSA screening test completed.
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.
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.

Full Information

First Posted
July 19, 2022
Last Updated
October 4, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05469269
Brief Title
Cleveland African American Prostate Cancer Project
Official Title
Cleveland African American Prostate Cancer Project: Equivalence of Passive Navigation, Active Navigation, and Community-based Screening for Completion of Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The data analyst will be blinded to the study arm assignments.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education and Passive Navigation
Arm Type
Experimental
Arm 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.
Arm Title
Education and Active Navigation
Arm Type
Experimental
Arm 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.
Arm Title
Education and Active Navigation with Community Based Outreach
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Passive Education
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Education by Community Navigator
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Education at Community Outreach Screening Event
Intervention Description
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 Information:
Title
PSA Screening Test
Description
The number of participants who had a PSA screening test completed.
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
PSA Screening Test
Description
The number of participants who had a PSA screening test completed.
Time Frame
At 14 months
Title
Primary Care Physician Visit
Description
The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.
Time Frame
At 4 months
Title
Primary Care Physician Visit
Description
The number of participants that followed up with a primary care physician for a visit or to establish long-term routine care.
Time Frame
At 14 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 English speaking Ability to consent to study Exclusion Criteria: Individuals who have had a prostatectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Trapl, PhD
Phone
216-368-8772
Email
CAAPP@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Trapl, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbershops Local to Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlies results in publication.
IPD Sharing Time Frame
Available immediately after publication with no end date.
IPD Sharing Access Criteria
Researchers who provide a sound proposal.

Learn more about this trial

Cleveland African American Prostate Cancer Project

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