NCT02611076

Smoking-cessation: A Spanish-Language Clinical Trial

Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smoking Cessation
• Tobacco Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Stop Smoking for Good Intervention in Spanish (SS-SP)	Assessments will occur at six-month intervals, through 24 months.
BEHAVIORAL	Usual care (UC)	Assessments will occur at six-month intervals, through 24 months.

Timeline

• Start date: 2015-10-15
• Primary completion: 2016-10-11
• Completion: 2021-10-28
• First posted: 2015-11-20
• Last updated: 2022-01-19

Locations

1 site across 1 country: United States