Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 1417
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Tobacco Abstinence at 6 Months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants With Tobacco Abstinence at 6 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.