Promoting Shared Decision Making in Prostate Cancer Through Decision Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
DVD Decision Aid
Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") AND the DVD decision aid ("Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer"), which provides instruction and recommendations on how to participate in shared decision making with one's physician.
干预措施: DVD Decision Aid (Behavioral)
Written Decision Aid
Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.
干预措施: Written decision aid (Behavioral)
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
Self-efficacy for discussing preferences (intention)
时间窗: Time 1 (baseline)
14 item survey instrument
次要结局
- Decisional regret(Time 4 (6 months post diagnosis))
- 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))
- 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))
- Preference for shared decision making(Time 1 (baseline))
- Preference for shared decision making(Time 2 (post-intervention, an average of 3 days after Time 1 baseline))
- Prostate cancer related knowledge(Time 1 (baseline))
- Prostate cancer related knowledge(Time 2 (post-intervention, an average of 3 days after Time 1 baseline))
- Prostate cancer related anxiety(Time 1 (baseline))
- Prostate cancer related anxiety(Time 2 (post-intervention, an average of 3 days after Time 1 baseline))
- Prostate cancer related anxiety(Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline))
- Treatment decision(Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline))
- Preference for shared decision making(Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline))
研究者
Angela Fagerlin
Associate Professor
University of Michigan