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临床试验/NCT05469269
NCT05469269招募中不适用

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

Case Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
PSA Screening Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •≥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

排除标准

  • •Individuals who have had a prostatectomy

研究组 & 干预措施

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.

干预措施: Education by Community Navigator (Behavioral)

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.

干预措施: Education at Community Outreach Screening Event (Behavioral)

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.

干预措施: Education by Community Navigator (Behavioral)

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.

干预措施: Passive Education (Behavioral)

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.

干预措施: Passive Education (Behavioral)

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.

干预措施: Passive Education (Behavioral)

结局指标

主要结局

PSA Screening Test

时间窗: At 4 months

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

次要结局

  • Primary Care Physician Visit(At 14 months)
  • PSA Screening Test(At 14 months)
  • Primary Care Physician Visit(At 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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