Spanish-Language Smoking Cessation Trial
Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
Results of a recently completed National Cancer Institute (NCI) funded trial of an intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24- month follow-up period, further supporting the utility of extended self-help for promoting and maintaining tobacco abstinence. Investigators have recognized that wide-scale implementation, and therefore public health impact, would be enhanced by the availability of a Spanish-language version to reach the largest and fastest growing ethnic minority population of smokers.
The goal of this study is to address this gap by testing a Spanish-language version of the validated self-help smoking cessation intervention. If demonstrated effective, the proposed intervention would represent an easily disseminable and low-cost intervention with significant public health impact for Hispanic/Latino smokers throughout the United States. The aims of this project are to test the efficacy of a Spanish-language version of a validated, extended self-help intervention for smoking cessation among Spanish-speaking smokers against usual care control. Participants (N = 1400) recruited nationally will be randomized to the two arms.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Tampa、Florida、美国、33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Smoking ≥ 5 tobacco cigarettes/week over the past year
- Not currently enrolled in a face-to-face smoking cessation program
- Monolingual Spanish-speaking, or bilingual Spanish-English and prefer receiving educational health materials in Spanish
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Extended Self-help
Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.
|
Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.
|
|
有源比较器：Usual Care (UC)
NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.
|
Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Tobacco Abstinence at 6 Months
大体时间：6 months
|
Participants will complete follow-up assessment packets at 6 month intervals through 24 months.
At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
|
6 months
|
|
Percentage of Participants With Tobacco Abstinence at 12 Months
大体时间：12 months
|
Participants will complete follow-up assessment packets at 6 month intervals through 24 months.
At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
|
12 months
|
|
Percentage of Participants With Tobacco Abstinence at 18 Months
大体时间：18 months
|
Participants will complete follow-up assessment packets at 6 month intervals through 24 months.
At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
|
18 months
|
|
Percentage of Participants With Tobacco Abstinence at 24 Months
大体时间：24 months
|
Participants will complete follow-up assessment packets at 6 month intervals through 24 months.
At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
|
24 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.