Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 498
- 试验地点
- 12
- 主要终点
- Decisional Satisfaction
研究概览
简要总结
The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.
Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.
About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 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, stage I or II
- •Diagnosis within the past 6 months
- •Has appointment with a consulting specialist at one of the clinical trial sites
- •Must be able to read and write English or Spanish at a 6th grade level
- •Must not have begun any treatment (except watchful waiting)
- •Must be able to complete baseline assessment before target clinician visit.
排除标准
- •Advanced prostate cancer
- •Diagnosed more than 6 months ago
- •Cannot read and write English or Spanish at a 6th grade level
- •Does not have appointment at one of the clinical trial sites
结局指标
主要结局
Decisional Satisfaction
时间窗: Baseline to 6 months
Satisfaction with Preparation for Decision Making
时间窗: Baseline to 1 month
Decisional Conflict
时间窗: Baseline to 6 months
次要结局
- Shift in decisional control preference from pre-decision to 1 month post-treatment(Baseline to 1 month)
- Resource utilization(Baseline to 6 months)
研究者
Donna Berry, PhD, RN, FAAN, ACON
Director, The Phyllis F. Cantor Center
Dana-Farber Cancer Institute