跳至主要内容
临床试验/NCT01516801
NCT01516801已完成不适用

A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
303
试验地点
2
主要终点
Rate of PSA testing

研究概览

简要总结

  1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
  2. Do patients find the flyer useful and understandable?

Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.

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
None

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men age 50-74 who were cared for in a general internal medicine clinic
  • had scheduled an annual health exam
  • had not had a PSA test within the previous year

排除标准

  • active cancer diagnosis
  • history of prostate cancer
  • need for PSA surveillance

结局指标

主要结局

Rate of PSA testing

时间窗: At the time of the annual exam (within two weeks of their annual physical)

Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical

Rate of documented PSA discussions

时间窗: At the time of the annual exam (within two weeks of their annual physical)

Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.

次要结局

  • Flyer acceptability(Within two weeks of the annual exam)
  • Perceived participation(Within two weeks)
  • Prostate Cancer Screening knowledge(Within two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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