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临床试验/NCT02206971
NCT02206971已完成不适用

Biomarker Feedback for Smoking Cessation

Masonic Cancer Center, University of Minnesota2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
urinary cotinine level

研究概览

简要总结

The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.

详细描述

The smoking pattern among adults in the US is undergoing a remarkable change. A substantial proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is known about how to help light smokers quit. The prevalence of light smoking is high (~50%) among African Americans (AAs) who compared to other groups have high cotinine levels, are less successful quitting smoking, and experience disproportionately higher smoking-related cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a potential smoking cessation strategy is therefore to provide light smokers with feedback on biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is to develop and pilot test a biomarker risk assessment intervention to enhance smoking cessation for AA light smokers. The proposal builds on our previous work that shows that light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well as preferences about how participants would like to receive biomarker feedback (BF; e.g. by mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a (BF) intervention for light smokers. The new intervention will undergo further feasibility evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures, (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with smoking reduction or cessation. By the end of the proposed pilot study, we expect to have developed a replicable, feasible, and acceptable BF intervention that will be ready for efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a BF intervention for smoking cessation in AA light smokers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female cigarette smokers, 18-75 years
  • Smoked an average of less than 10 cigarettes per day during past month
  • A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

排除标准

  • Only one subject per household may participate
  • Pregnancy

结局指标

主要结局

urinary cotinine level

时间窗: week 0, week 8, week 26

changes to biomarker levels with smoking reduction or cessation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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