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临床试验/NCT02945787
NCT02945787已完成不适用

Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 1,417 人开始时间: 2016年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,417
试验地点
1
主要终点
Percentage of Participants With Tobacco Abstinence at 6 Months

研究概览

简要总结

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 ≥ 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

排除标准

  • 未提供

研究组 & 干预措施

Extended Self-help

Experimental

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.

干预措施: Spanish-Language Version of the Stop Smoking for Good (Behavioral)

Usual Care (UC)

Active Comparator

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.

干预措施: NCI-Produced Spanish-language Self-help Booklet (Behavioral)

结局指标

主要结局

Percentage of Participants With Tobacco Abstinence at 6 Months

时间窗: 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.

Percentage of Participants With Tobacco Abstinence at 12 Months

时间窗: 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.

Percentage of Participants With Tobacco Abstinence at 24 Months

时间窗: 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.

Percentage of Participants With Tobacco Abstinence at 18 Months

时间窗: 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.

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 (1)

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