Communicating Multiple Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,184
- 试验地点
- 1
- 主要终点
- Change in decisions
研究概览
简要总结
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
详细描述
Many newer cancer drugs are approved before uncertainties with their underlying clinical trial evidence have been adequately studied, in turn making it difficult to accurately determine the drug's benefits and harms. Prescription drug information rarely communicates these uncertainties. In a nationally representative sample of US adults, this study will evaluate the effect of using brief statements to communicate multiple different sources of uncertainties about the benefits and harms of new cancer drugs on participants' decisions.
In the pre-intervention phase, participants will be given information about a hypothetical new drug approved for the treatment of non-small cell lung cancer. Participants will be asked how likely they would be to take the drug, and how certain they are that the drug will work. Participants will then be randomized with equal allocation to 1 of 5 groups. The control group will receive information about a new cancer drug's benefits and harms; the intervention groups will also be given brief statements about sources of uncertainties with the drug's evidence (1, 2, 3, or 4 sources of uncertainties). The post-intervention questions will re-assess participants' decision making, perceptions of uncertainty, emotions, understanding, and trust.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older
- •Adults fluent in English
- •Adults residing in the United States
排除标准
- •Participants who do not meet each of the 3 inclusion criteria
- •Participants who initiated the first survey about communicating individual sources of uncertainties (verified using unique participant identifiers assigned by the survey company)
研究组 & 干预措施
1 source of uncertainty
Other: Statement communicating uncertainty with small magnitude of benefit
干预措施: Statement communicating 1 source of uncertainty (Other)
Control group
No information about uncertainty given.
干预措施: Control group (Other)
2 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit and limited study population
干预措施: Statements communicating 2 sources of uncertainties (Other)
3 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, and unvalidated surrogate endpoint
干预措施: Statements communicating 3 sources of uncertainties (Other)
4 sources of uncertainties
Other: Statements communicating uncertainty with a small magnitude of benefit, limited study population, unvalidated surrogate endpoint, and limited study duration.
干预措施: Statements communicating 4 sources of uncertainties (Other)
结局指标
主要结局
Change in decisions
时间窗: Immediately prior to and after the intervention.
"Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely are you to take the new drug, Zenova?" 4-point Likert scale for decision-making: very likely; somewhat likely; somewhat unlikely; very unlikely
次要结局
- Change in understanding(Immediately prior to and after the intervention.)
- Change in perception of uncertainty(Immediately prior to and after the intervention.)
- Change in emotions(Immediately prior to and after the intervention.)
- Trust(Immediately prior to and after the intervention.)