Spanish-Language Smoking Cessation Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smoking-cessation: A Spanish-Language Clinical Trial

NCT02611076

Smoking Cessation Tobacco Dependence

COMPLETED NA

Extended Self-Help for Smoking Cessation

NCT01352195

Smoking Cessation

COMPLETED NA

Determinants of Smoking Cessation Among Latinos

NCT01008748

Smoking Cessation

COMPLETED NA

Tobacco Cessation Training Program in Spanish-speaking Countries

NCT02718872

Smoking Smoking Cessation

COMPLETED NA

SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language

NCT06487806

Smoking Cessation

SUSPENDED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Extended Self-help

Spanish-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.

Group Type EXPERIMENTAL

Spanish-Language Version of the Stop Smoking for Good

Intervention Type BEHAVIORAL

Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.

Usual Care (UC)

NCI-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.

Group Type ACTIVE_COMPARATOR

NCI-Produced Spanish-language Self-help Booklet

Intervention Type BEHAVIORAL

Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spanish-Language Version of the Stop Smoking for Good

Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.

Intervention Type BEHAVIORAL

NCI-Produced Spanish-language Self-help Booklet

Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes