跳至主要内容
临床试验/NCT02053389
NCT02053389已完成不适用

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

University of Michigan2 个研究点 分布在 1 个国家目标入组 564 人开始时间: 2010年11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
564
试验地点
2
主要终点
Self-efficacy for discussing preferences (actual)

研究概览

简要总结

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

  • increase patients' perceptions of the importance of their preferences to their decision making
  • increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
  • increase patients' actual engagement with their physician during the clinical encounter
  • increase the concordance between patient decision making preferences and actual decision making outcomes
  • increase long term satisfaction with decision on type of treatment selected
  • increase patient satisfaction with their decision and the decision making process
  • influence patient perception of his physician (e.g., trust) and of the diagnosis visit

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • Men aged 18 years and older
  • Scheduled for a prostate biopsy to test for prostate cancer
  • Ability to read and answer survey questions in English

排除标准

  • Previous diagnosis of prostate cancer

结局指标

主要结局

Self-efficacy for discussing preferences (actual)

时间窗: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

14 item survey instrument

Self-efficacy for discussing preferences (intention)

时间窗: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

14 item survey instrument

次要结局

  • Treatment preference(Time 2 (post-intervention, an average of 3 days after Time 1 baseline))
  • Preference for shared decision making(Time 4 (6 months post diagnosis))
  • Decisional regret(Time 4 (6 months post diagnosis))
  • Prostate cancer related knowledge(Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline))
  • Prostate cancer related anxiety(Time 4 (6 months post diagnosis))
  • Treatment decision(Time 4 (6 months post diagnosis))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Fagerlin

Associate Professor

University of Michigan

研究点 (2)

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