Feasibility and Smokers' Reactions to DNA Feedback
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Degree of participant understanding of materials, to be measured by a survey
研究概览
简要总结
The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid) damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.
详细描述
The study aims to recruit 50 smokers who are not engaged in quitting. The study will involve two in-person visits. During visit 1, participants will complete a baseline survey and have their blood drawn. Approximately two weeks later, in visit 2, smokers will be randomized in a 1:2:2 ratio to one of three arms:
- education about harms of smoking (control group);
- same education plus information on DNA damage and biomarker feedback (biomarker arm) without visual of damage; or
- same as arm 2 except accompanied with visuals of participants' normal and DNA damage cells. Participants in the this arm will be informed of their proportion of leucocytes showing DNA damage with pictures of their normal and damaged cells.
The goal of the analyses is to obtain effect size estimates (direction, confidence intervals) to inform if results align with hypotheses and obtain insights about reactions about the feedback (Aim 1). The study will collect feasibility data from baseline to three months (e.g., percentage who show up to the sessions, attrition).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smoke > 5 cig/day during the last week
- •be open to biomarker feedback
- •not actively trying to quit
排除标准
- •smoker carbon monoxide level(CO < 10 ppm)
研究组 & 干预措施
Control
Subjects will review standard health information on the health consequences of smoking.
Subjects will have blood drawn but it will not be tested for DNA damage.
干预措施: standard health information (Behavioral)
Biomarker feedback
Subjects will review this standardized health information, plus receive information on DNA damage along with feedback of their DNA damage.
Subjects will have blood drawn and the feedback will be presented at Visit 2.
干预措施: standard health information plus info. on DNA damage (Behavioral)
Biomarker feedback plus
Subjects will review this standardized health information, information on DNA damage along with feedback of their DNA damage, and will also will see images of their own cells with and without DNA damage.
Subjects will have blood drawn and the feedback and images will be presented at Visit 2.
干预措施: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage (Behavioral)
结局指标
主要结局
Degree of participant understanding of materials, to be measured by a survey
时间窗: week 3
Study will measure the extent to which the biomarker information was understood, as measured by a survey
Percentage of subjects who show up to the sessions
时间窗: Week 3
Study will collect feasibility data on how many participants come to each visit.
Extent to which participants believe the feedback to be accurate
时间窗: Week 3
The study will measure the extent to which DNA damage results would be considered accurate using an interview.
Degree of participant understanding of materials, to be measured by an interview
时间窗: Week 3
Study will measure the extent to which the biomarker information was understood, as measured by an interview.
Extent to which participants believe the feedback to be trustworthy
时间窗: Week 3
The study will measure the extent to which DNA damage results would be considered trustworthy using a survey.
次要结局
- Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on(Baseline to 3 months)
- Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on(Baseline to 3 months)
- Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on(Baseline to 3 months)
- Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on(Baseline to 3 months)
- Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention(3 months)
- Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention(3 months)
- Effect size of the quit rate between the control and biomarker arm at three months post-intervention(3 months)