A Patient-Centered Approach to Integration of Life Expectancy Into Treatment Decision Making for Patients With Genitourinary Malignancy
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Decisional Conflict
研究概览
简要总结
Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.
详细描述
Subjects in the intervention arm will be provided with life expectancy estimates specific to their age and health status. Life expectancy estimates for prostate and kidney cancer patients will be estimated by age and Charlson comorbidity score cutoffs, and life expectancy for bladder cancer patients will be determined using definitions as noted by Cho et al. Talking points will be provided to counseling physicians on how to meaningfully communicate life expectancy data. Subjects will also complete a computer-based conjoint analysis exercise prior to the counseling visit; results will be used to help physicians understand how the subject values life expectancy compared with other decision attributes. The control arm will consist of the current standard of care for treatment counseling.
The intervention will be randomized at the level of the patient after stratification by type of cancer.
All participants will be asked to fill out a validated questionnaire to measure decisional conflict at the conclusion of their counseling visit. Investigators will audiotape treatment counseling visits to allow for qualitative analysis of the quality of communication of life expectancy information. Treatment choice will be documented to assess rates of aggressive versus non-aggressive treatment among patients with limited life expectancy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed clinical T1-2 prostate adenocarcinoma with Gleason scores of 7 or less
- •Newly diagnosed clinical T1a kidney cancer or renal masses < 4cm
- •Newly diagnosed clinical T2 nonmetastatic urothelial carcinoma of the bladder
排除标准
- •Under 18 years of age
- •Subjects with difficulty communicating or dementia
- •Non-English speakers
结局指标
主要结局
Decisional Conflict
时间窗: At time of treatment decision, up to 12 weeks after diagnosis
Decisional conflict evaluated based on the total decisional conflict score (DCS). The scale measures the degree of certainty/uncertainty an individual feels in selecting choices, feelings of being uninformed or unclear about values, and feelings of satisfaction with the selected decision. Scores range from 0 to 100. A total score of 0 indicates no decisional conflict, while a score of 100 indicates extremely high levels of decisional conflict.
次要结局
- Number of questions asked about life expectancy(At time of treatment decision, up to 12 weeks after diagnosis)
- Mention of life expectancy(At time of treatment decision, up to 12 weeks after diagnosis)
- Time devoted to life expectancy(At time of treatment decision, up to 12 weeks after diagnosis)
- Treatment Choice(At time of treatment decision, up to 12 weeks after diagnosis)
研究者
Timothy J. Daskivich
Principal Investigator
Cedars-Sinai Medical Center