Smoking-cessation: A Spanish-Language Clinical Trial

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Tobacco Dependence; Smoking Cessation

Treatments: Behavioral: Usual care (UC); Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02611076

MCC-18231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Stop Smoking for Good Intervention in Spanish

Experimental group

Description:

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.

Treatment:

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

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual care (UC)