CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Increase in KUJ score through education
研究概览
简要总结
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
详细描述
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:
- patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
- measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
- the treatments selected, and
- 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 40 to 85 years
- •Sex: male
- •Race/ethnicity: no restrictions
- •Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
- •localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR
- •Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml
- •Willing to participate and able to give informed consent
- •Able to adequately see the study intervention which is an interactive decision dashboard & complete study-related questionnaires
- •Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires
排除标准
- •Unable to complete study-related tasks due to cognitive deficits or English non-fluency
- •Unwilling to participate.
- •Deemed clinically unsuitable for active surveillance as a prostate cancer management option
研究组 & 干预措施
Control
No use of the decision aid dashboard before, during or after the treatment decision time period.
Dashboard
Use of the decision aid dashboard before, during and after the treatment decision time period.
干预措施: Dashboard (Behavioral)
结局指标
主要结局
Increase in KUJ score through education
时间窗: 2 years
The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.
次要结局
- Measure of overall quality and satisfaction with initial treatment decision.(2 years)
研究者
James Dolan
Associate Professor
University of Rochester