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Trial record 67 of 2035 for:    Smoking Cessation

Smoking-cessation: A Spanish-Language Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02611076
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
James and Esther King Biomedical Research Program
University of Miami
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Dependence Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP) Behavioral: Usual care (UC) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Clinical Trial
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : October 11, 2016
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP)
Assessments will occur at six-month intervals, through 24 months.

Active Comparator: 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.
Behavioral: Usual care (UC)
Assessments will occur at six-month intervals, through 24 months.




Primary Outcome Measures :
  1. Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials [ Time Frame: Up to 12 months ]
    Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial.

  2. Study II: Rate of Smoking Cessation [ Time Frame: Up to 24 months ]
    Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611076


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
University of Miami
Investigators
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Principal Investigator: Vani N. Simmons, Ph.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02611076     History of Changes
Other Study ID Numbers: MCC-18231
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
smoking cessation
self-help
Spanish language

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders