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临床试验/NCT01415375
NCT01415375已完成2 期

Prostate Cancer Education in African American Men

Temple University2 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
490
试验地点
2
主要终点
Knowledge about prostate cancer and prostate cancer tests

研究概览

简要总结

This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

详细描述

African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).

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)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 45 to 70 year old
  • African descent
  • accessible by telephone
  • have primary care physician

排除标准

  • Prostate cancer test in 12 months prior to enrollment
  • History of prostate cancer

结局指标

主要结局

Knowledge about prostate cancer and prostate cancer tests

时间窗: baseline and 8 months post randomization

12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure.

Decisional conflict

时间窗: 8 months post randomization

Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations.

Verified doctor visit to discuss prostate cancer testing

时间窗: 2 years post randomization

Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records

congruence between prostate cancer testing intention and behavior

时间窗: 1 and 2 years post randomization

Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0).

次要结局

  • State anxiety(baseline and 8 months post-randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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