Overview

This trial is active, not recruiting.

Conditions smoking cessation, tobacco dependence
Treatments stop smoking for good intervention in spanish (ss-sp), usual care (uc)
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator James and Esther King Biomedical Research Program
Start date October 2015
End date October 2016
Trial size 42 participants
Trial identifier NCT02611076, MCC-18231

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.

United States Florida
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Study II: Stop Smoking for Good Intervention in Spanish (SS-SP) will comprise a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 9 supportive pamphlets developed in Study I. Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP) Assessments will occur at six-month intervals, through 24 months.
stop smoking for good intervention in spanish (ss-sp)
Assessments will occur at six-month intervals, through 24 months.
(Active Comparator)
Study II: Usual Care (UC) will comprise a single, Spanish-language, smoking cessation booklet developed by the National Cancer Institute (NCI). Behavioral: Usual care (UC) Assessments will occur at six-month intervals, through 24 months.
usual care (uc)
Assessments will occur at six-month intervals, through 24 months.

Primary Outcomes

Measure
Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials
time frame: Up to 12 months
Study II: Rate of Smoking Cessation
time frame: Up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial
Principal investigator Vani N. Simmons, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.