Smoking-cessation: A Spanish-Language Clinical Trial

NCT ID: NCT02611076

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-15
• Study Completion Date: 2021-10-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Stop Smoking for Good Intervention in Spanish

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Usual care (UC)

Intervention Type: BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Interventions

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

Assessments will occur at six-month intervals, through 24 months.

Intervention Type: BEHAVIORAL

Usual care (UC)

Assessments will occur at six-month intervals, through 24 months.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James and Esther King Biomedical Research Program

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vani N. Simmons, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-18231

Identifier Type: -

Identifier Source: org_study_id