跳至主要内容
临床试验/NCT00630188
NCT00630188已完成不适用

Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

University of North Carolina8 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2005年3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
128
试验地点
8
主要终点
Men's understanding that prostate cancer screening requires a decision

研究概览

简要总结

The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

详细描述

Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.

Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

研究设计

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

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Ages 40-80 years
  • Their physician agreed to participate in the study
  • Seen in practice for at least one year

排除标准

  • Prior history of prostate cancer
  • Presenting for acute medical visit
  • Non-skin cancer
  • Lung disease requiring oxygen
  • Renal failure requiring dialysis
  • Intensive care visit in last 6 months
  • Need assistance with activities of daily living

结局指标

主要结局

Men's understanding that prostate cancer screening requires a decision

时间窗: baseline, post intervention, post clinical visit

Men's knowledge about prostate cancer and prostate cancer screening

时间窗: baseline, post intervention, post clinical visit

Men's participation in the decision about prostate cancer screening with their clinician at their preferred level

时间窗: baseline, post intervention, post clinical visit

次要结局

  • The presence of a shared decision(post clinical visit)
  • men's intent to be screened for prostate cancer(post clinical visit)
  • Self reported screening(post visit)
  • Actual screening by chart review(9 month follow-up)

研究者

申办方类型
Other

研究点 (8)

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