Smoking-cessation: A Spanish-Language Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.

Detailed Description
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Study Aim 1: To transcreate the existing English-language 10 Stop Smoking for Good booklets and accompanying 9 supportive My Story pamphlets into a series of culturally relevant and acceptable materials for Spanish-speaking smokers who prefer to receive health information in Spanish. The adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of Hispanic/Latino smokers representing diverse subcultural groups. Study Aim 2: To test the efficacy of the self-help intervention developed in Study I among Spanish-speaking smokers in a randomized controlled trial. Participants (500) will be randomized to receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention or usual care (UC) comprising an existing booklet from NCI. Investigators hypothesize SS-SP will produce higher abstinence rates than UC through 24 months. Secondary Aim: Test moderator variables to improve targeting the intervention. Moderator analyses will be exploratory, without strong a priori hypotheses.

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

Conditions
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Smoking Cessation, Tobacco Dependence

Intervention / Treatment
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* Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP)
* Behavioral: Usual care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish. Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish. ≥ 1 year history of smoking Smoking ≥ 5 cigarettes per week Age ≥ 18 years Not currently enrolled in a face-to-face smoking cessation program

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stop Smoking for Good Intervention in Spanish<br>Study II: Stop Smoking for Good Intervention in Spanish (SS-SP) will comprise a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 9 supportive pamphlets developed in Study I. Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP) Assessments will occur at six-month intervals, through 24 months. | Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP)<br>* Assessments will occur at six-month intervals, through 24 months.<br>|
| Active Comparator: Usual Care<br>Study II: Usual Care (UC) will comprise a single, Spanish-language, smoking cessation booklet developed by the National Cancer Institute (NCI). Behavioral: Usual care (UC) Assessments will occur at six-month intervals, through 24 months. | Behavioral: Usual care (UC)<br>* Assessments will occur at six-month intervals, through 24 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials | Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial. | Up to 12 months | 
| Study II: Rate of Smoking Cessation | Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, self-help, Spanish language