Smoking-cessation: A Spanish-Language Clinical Trial

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 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.

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.

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.

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

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