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Clinical Trials/NCT02945787
NCT02945787
Completed
Not Applicable

Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country1,417 target enrollmentOctober 24, 2016

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2016
End Date
July 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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.

Study Sites (1)

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