Smoking Cessation, Tobacco Dependence
Conditions
Keywords
smoking cessation, self-help, Spanish language
Brief summary
The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.
Detailed description
Study Aim 1: To transcreate the existing English-language 10 Stop Smoking for Good booklets and accompanying 9 supportive My Story pamphlets into a series of culturally relevant and acceptable materials for Spanish-speaking smokers who prefer to receive health information in Spanish. The adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of Hispanic/Latino smokers representing diverse subcultural groups. Study Aim 2: To test the efficacy of the self-help intervention developed in Study I among Spanish-speaking smokers in a randomized controlled trial. Participants (500) will be randomized to receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention or usual care (UC) comprising an existing booklet from NCI. Investigators hypothesize SS-SP will produce higher abstinence rates than UC through 24 months. Secondary Aim: Test moderator variables to improve targeting the intervention. Moderator analyses will be exploratory, without strong a priori hypotheses.
Interventions
BEHAVIORALStop Smoking for Good Intervention in Spanish (SS-SP)
Assessments will occur at six-month intervals, through 24 months.
BEHAVIORALUsual care (UC)
Assessments will occur at six-month intervals, through 24 months.
Sponsors
James and Esther King Biomedical Research Program
University of Miami
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish. * Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish. * ≥ 1 year history of smoking * Smoking ≥ 5 cigarettes per week * Age ≥ 18 years * Not currently enrolled in a face-to-face smoking cessation program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials | Up to 12 months | Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial. |
| Study II: Rate of Smoking Cessation | Up to 24 months | Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm. |
Countries
United States
Outcome results
None listed