Smoking-cessation: A Spanish-Language Clinical Trial
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
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
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
|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.|
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