Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of initial interviews completed in 60 minutes
研究概览
简要总结
The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.
If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.
详细描述
To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Life expectancy > 10 years
- •Ability to read English
排除标准
- •Personal history of prostate cancer
- •Personal history of prostate biopsy or prostate surgery
- •Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit
- •Cognitive impairment
研究组 & 干预措施
Prostate Cancer Decision Aid
The research intervention will be exposure to the screening decision aid. Patients will receive standardized counseling including population based risks and benefits of prostate cancer screening. Then, patients will be given opportunity to review the screening decision aid prior to offering a decision on whether or not to undergo prostate cancer screening. The patient decision aid will be a computer application that generates predicted risks associated with prostate cancer.
干预措施: Prostate cancer decision aid (Behavioral)
结局指标
主要结局
Number of initial interviews completed in 60 minutes
时间窗: 60 minutes from beginning of interview
To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.
次要结局
- Health Literacy(1 month after clinical visit)
- Decisional conflict Scale(1 month after clinical visit)
- Decisional regret scale(1 month after clinical visit)
- Multidimensional measure of informed choice(1 month after clinical visit)
- Patient decisional control preferences(1 month after clinical visit)