Spanish-Language Smoking Cessation Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Spanish-Language Version of the Stop Smoking for Good
* Behavioral: NCI-Produced Spanish-language Self-help Booklet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Self-help<br>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. | Behavioral: Spanish-Language Version of the Stop Smoking for Good<br>* Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.<br>|
| Active Comparator: Usual Care (UC)<br>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. | Behavioral: NCI-Produced Spanish-language Self-help Booklet<br>* Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Tobacco Abstinence at 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spanish speaking, self-help, tobacco abstinence, public health, Forever Free, Stop Smoking for Good