Spanish-Language Smoking Cessation Trial

Not Applicable

Completed

• Conditions: Smoking Cessation

• 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

Study Timeline

• Study Start: 2016-10-24
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Results First Submitted: 2021-07-27
• Results First Submitted QC: 2021-08-20
• Results First Posted: 2021-09-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

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

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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States