Smoking-cessation: A Spanish-Language Clinical Trial

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611076
• Other study ID #: MCC-18231
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: October 28, 2021

Study information

• Verified date: January 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 28, 2021
• Est. primary completion date: October 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Stop Smoking for Good Intervention in Spanish (SS-SP)
Assessments will occur at six-month intervals, through 24 months.
• Usual care (UC)
Assessments will occur at six-month intervals, through 24 months.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	James and Esther King Biomedical Research Program, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Primary	Study II: Rate of Smoking Cessation	Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.	Up to 24 months

External Links

•   Moffitt Cancer Center Clinical Trials website