Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Study II: Rate of Smoking Cessation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Study II: Rate of Smoking Cessation
Time Frame: Up to 24 months
Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.
Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials
Time Frame: Up to 12 months
Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial.