Extended Self-Help for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,124
- 试验地点
- 2
- 主要终点
- 7-Day Point-Prevalence Abstinence at Each Follow-up Point
研究概览
简要总结
The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.
详细描述
The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •smoking at least five cigarette per day over the past year
- •not currently enrolled in a face-to-face smoking cessation program
- •able to speak and read English
- •desire to quit smoking, as indicated by a score of at least 5 ("Think I should quit, but not quite ready") on the Contemplation Ladder (Biener & Abrams, 1991)
排除标准
- •number of participants from the same street address limited to 1
- •no more than 2 referrals per participant
结局指标
主要结局
7-Day Point-Prevalence Abstinence at Each Follow-up Point
时间窗: 30 months per participant
Time will be measured in months from the start of condition. Potential confounding variables (e.g., group differences in demographic, smoking history, or pharmacotherapy use) will be adjusted for in the model. Pair-wise condition and time interval comparisons will be tested using the generalized score statistics from generalized estimating equations (GEE) models by utilizing the contrast statements.
次要结局
未报告次要终点