Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 4
- 主要终点
- Preparation for decision making
研究概览
简要总结
The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level
- •Biopsy done at enrolling site
- •Upcoming appointment with consulting specialist at enrolling study site
- •Able to read, write, understand English
排除标准
- •Two or more post-biopsy specialist consults
- •Begun treatment (or active surveillance)
研究组 & 干预措施
Usual patient education + standard educational websites
干预措施: Standard prostate cancer information websites (Behavioral)
Usual patient education + P3P decision support website
干预措施: Personal Patient Profile - Prostate (P3P) (Behavioral)
结局指标
主要结局
Preparation for decision making
时间窗: 1-month after study entry
Graham and O'Connor, 1995, Preparation for decision making scale
Decisional conflict
时间窗: Change from baseline to 6-months
O'Connor, 1995, Decisional conflict scale
Satisfaction with decision
时间窗: 6-months after study entry
Holmes-Rovner et al, 1996, Satisfaction with decision scale
次要结局
- Concordance of care choice selected with self-reported influential personal preferences(6-months from study entry)
- Net cost and benefit of the intervention(1-week after study entry)
- Time to treatment decision(6-months from study entry)
研究者
Donna Berry, PhD, RN, FAAN, ACON
Principal Investigator
Dana-Farber Cancer Institute