Spanish-Language Smoking Cessation Trial
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: Spanish-Language Version of the Stop Smoking for GoodBehavioral: NCI-Produced Spanish-language Self-help Booklet
- Registration Number
- NCT02945787
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1417
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended Self-help Spanish-Language Version of the Stop Smoking for Good 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. Usual Care (UC) NCI-Produced Spanish-language Self-help Booklet 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Tobacco Abstinence at 6 Months 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 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States