Spanish-Language Smoking Cessation Trial

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Spanish-Language Version of the Stop Smoking for Good; Behavioral: NCI-Produced Spanish-language Self-help Booklet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02945787

R01CA199143 (U.S. NIH Grant/Contract)

MCC-18633

Details and patient eligibility

About

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.

Enrollment: 1,417 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,417 participants in 2 patient groups

Extended Self-help

Experimental group

Description:

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.

Treatment:

Behavioral: Spanish-Language Version of the Stop Smoking for Good

Usual Care (UC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: NCI-Produced Spanish-language Self-help Booklet