Investigating Information Preferences, Risk Perceptions, and Tradeoffs in Multi-Cancer Early Detection Decisions: A Randomized Vignette Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Decisional Conflict
研究概览
简要总结
The goal of this clinical trial is to learn what people's informational preferences and risk perceptions are in regards to the use of multi-cancer early detection (MCED) tests. Participants will be asked to review three informational factors about MCED tests and complete a survey about their intentions to use an MCED test. Some participants will also be asked to complete an interview.
详细描述
This is a clinical trial using a randomized vignette design where the vignette sequentially introduces 3 information factors to participants. This allows for the effect of each informational factor to be tested in the context of the preceding sequence of factors. In this study, the investigators will deliver the vignette in three phases, varying the level of detail of one factor in each phase, resulting in 8 combinations of study conditions. Participants will be randomly assigned to these conditions and repeated measures of outcomes of interest will be derived from survey assessments conducted after each informational factor is presented. At the end of trial participation, respondents will be invited to participate in one qualitative interview lasting 30-45 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-74
- •Speak English or Spanish
排除标准
- •Prior diagnosis of cancer (with the exception of non-melanoma skin cancers)
- •Previous use of a Multi-Cancer Early Detection (MCED) test.
研究组 & 干预措施
Arm 3: High, Low, Low
干预措施: Test Performance Information: High Detail (Behavioral)
Arm 3: High, Low, Low
干预措施: Diagnostic Workup Information: Low Detail (Behavioral)
Arm 3: High, Low, Low
干预措施: Test and Workup Cost Information: Low Detail (Behavioral)
Arm 4: High, Low, High
干预措施: Test Performance Information: High Detail (Behavioral)
Arm 4: High, Low, High
干预措施: Diagnostic Workup Information: Low Detail (Behavioral)
Arm 4: High, Low, High
干预措施: Test and Workup Cost Information: High Detail (Behavioral)
Arm 5: Low, High, High
干预措施: Test Performance Information: Low Detail (Behavioral)
Arm 5: Low, High, High
干预措施: Diagnostic Workup Information: High Detail (Behavioral)
Arm 5: Low, High, High
干预措施: Test and Workup Cost Information: High Detail (Behavioral)
Arm 6: Low, Low, High
干预措施: Test Performance Information: Low Detail (Behavioral)
Arm 6: Low, Low, High
干预措施: Diagnostic Workup Information: Low Detail (Behavioral)
Arm 6: Low, Low, High
干预措施: Test and Workup Cost Information: High Detail (Behavioral)
Arm 7: Low, High, Low
干预措施: Test Performance Information: Low Detail (Behavioral)
Arm 7: Low, High, Low
干预措施: Diagnostic Workup Information: High Detail (Behavioral)
Arm 7: Low, High, Low
干预措施: Test and Workup Cost Information: Low Detail (Behavioral)
Arm 8: Low, Low, Low
干预措施: Test Performance Information: Low Detail (Behavioral)
Arm 8: Low, Low, Low
干预措施: Diagnostic Workup Information: Low Detail (Behavioral)
Arm 8: Low, Low, Low
干预措施: Test and Workup Cost Information: Low Detail (Behavioral)
Arm 2: High, High, Low
干预措施: Test Performance Information: High Detail (Behavioral)
Arm 2: High, High, Low
干预措施: Diagnostic Workup Information: High Detail (Behavioral)
Arm 2: High, High, Low
干预措施: Test and Workup Cost Information: Low Detail (Behavioral)
Arm 1: High, High, High
干预措施: Test Performance Information: High Detail (Behavioral)
Arm 1: High, High, High
干预措施: Diagnostic Workup Information: High Detail (Behavioral)
Arm 1: High, High, High
干预措施: Test and Workup Cost Information: High Detail (Behavioral)
结局指标
主要结局
Decisional Conflict
时间窗: 24 hours
A validated 10-item scale scored 0-100 that assesses decisional conflict using a 3-point Likert for each item; Includes 4 subscales: informed, uncertainty, values clarity, and support. The full scale will be administered after the third vignette is presented (Time 3).
次要结局
- Screening Intentions(24 hours)
- Informed Subscale of the Decisional Conflict Scale(24 hours)
- Uncertainty Subscale of the Decisional Conflict Scale(24 hours)
研究者
Christine M. Gunn
Associate Professor of Health Policy and Clinical Practice
Trustees of Dartmouth College