N/A
Completed N=1,417
Spanish-Language Smoking Cessation Trial
Source: ClinicalTrials.gov NCT02945787 ↗Enrolled (actual)
1,417
Serious AEs
—
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Tobacco Abstinence at 6 Months — 21.7; 11.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Tobacco Abstinence at 6 Months |
21.7; 11.3 | — |
| PRIMARY Percentage of Participants With Tobacco Abstinence at 12 Months |
28.4; 17.0 | — |
| PRIMARY Percentage of Participants With Tobacco Abstinence at 18 Months |
29.3; 20.7 | — |
| PRIMARY Percentage of Participants With Tobacco Abstinence at 24 Months |
33.1; 23.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02945787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.