Smoking-cessation: A Spanish-Language Clinical Trial

H. Lee Moffitt Cancer Center and Research Institute42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Smoking Cessation Tobacco Dependence

Interventions

Stop Smoking for Good Intervention in Spanish (SS-SP)BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Usual care (UC)BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials

Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial.

Time frame: Up to 12 months

Study II: Rate of Smoking Cessation

Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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