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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02611076
Other study ID # MCC-18231
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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