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Spanish-Language Smoking Cessation Trial

Not Applicable
Completed
Conditions
Smoking Cessation
Interventions
Behavioral: Spanish-Language Version of the Stop Smoking for Good
Behavioral: NCI-Produced Spanish-language Self-help Booklet
Registration Number
NCT02945787
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Extended Self-helpSpanish-Language Version of the Stop Smoking for GoodSpanish-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 BookletNCI-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
NameTimeMethod
Percentage of Participants With Tobacco Abstinence at 6 Months6 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 Months12 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 Months24 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 Months18 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
NameTimeMethod

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

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