Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs).
研究概览
简要总结
The goal of the study is to adapt and test a participant decision aid about lung cancer screening for use with patients in theHarris Health System (HHS).
详细描述
The study has two phases. In the first phase, the investigators will conduct a cultural and linguistic adaptation of a patient decision aid video on lung cancer screening for use with patients with low health literacy in English and Spanish. They will produce adapted decision aid videos and written educational materials about lung cancer screening. They will survey providers about their lung cancer screening practices, conduct focus groups to learn what patients want to know about screening, and perform cognitive interviews with patients to make sure the adapted videos and educational materials are easy to understand.
In the second phase, the investigators will test the adapted lung cancer screening decision aid videos in English and Spanish to determine acceptability and impact of the aids on decision making outcomes. Patients will be randomized to evaluate an adapted video decision aid intervention or a control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-80 years of age
- •Current smokers or smokers who have quit less than 15 years ago
- •Speak either English or Spanish
- •No history of lung cancer
- •Family member of someone with a history of smoking AND lung cancer
排除标准
- 未提供
研究组 & 干预措施
Pilot Study: Control Patients (Aim 2)
Up to 50 participants (25 English speakers, 25 Spanish speakers)
干预措施: Colon cancer screening video (Behavioral)
Needs Assessment: Provider Survey (Aim 1)
Up to 200 physicians and other health professionals
干预措施: Surveys (Other)
Needs Assessment: Patient/Family member Focus Groups (Aim 1)
Up to 20 participants who speak English or Spanish
干预措施: Focus groups (Other)
Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)
Up to 40 participants who speak English or Spanish
干预措施: Cognitive Interviews (Other)
Pilot Study: Intervention Patients (Aim 2)
Up to 50 participants (25 English speakers, 25 Spanish speakers)
干预措施: Lung cancer screening decision aid video (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs).
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点