Spanish-Language Smoking Cessation Trial
Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
2 other identifiers
interventional
1,417
1 country
1
Brief Summary
Results of a recently completed National Cancer Institute (NCI) funded trial of an intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24- month follow-up period, further supporting the utility of extended self-help for promoting and maintaining tobacco abstinence. Investigators have recognized that wide-scale implementation, and therefore public health impact, would be enhanced by the availability of a Spanish-language version to reach the largest and fastest growing ethnic minority population of smokers. The goal of this study is to address this gap by testing a Spanish-language version of the validated self-help smoking cessation intervention. If demonstrated effective, the proposed intervention would represent an easily disseminable and low-cost intervention with significant public health impact for Hispanic/Latino smokers throughout the United States. The aims of this project are to test the efficacy of a Spanish-language version of a validated, extended self-help intervention for smoking cessation among Spanish-speaking smokers against usual care control. Participants (N = 1400) recruited nationally will be randomized to the two arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2016
CompletedFirst Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedNovember 4, 2022
November 1, 2022
3.7 years
October 25, 2016
July 27, 2021
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Tobacco Abstinence at 6 Months
Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
6 months
Percentage of Participants With Tobacco Abstinence at 12 Months
Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
12 months
Percentage of Participants With Tobacco Abstinence at 18 Months
Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
18 months
Percentage of Participants With Tobacco Abstinence at 24 Months
Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates.
24 months
Study Arms (2)
Extended Self-help
EXPERIMENTALSpanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers.
Usual Care (UC)
ACTIVE COMPARATORNCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere.
Interventions
Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.
Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.
Eligibility Criteria
You may qualify if:
- Smoking ≥ 5 tobacco cigarettes/week over the past year
- Not currently enrolled in a face-to-face smoking cessation program
- Monolingual Spanish-speaking, or bilingual Spanish-English and prefer receiving educational health materials in Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- National Cancer Institute (NCI)collaborator
- Florida Department of Healthcollaborator
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Publications (1)
Simmons VN, Sutton SK, Medina-Ramirez P, Martinez U, Brandon KO, Byrne MM, Meade CD, Meltzer LR, Brandon TH. Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial. Cancer. 2022 Mar 1;128(5):984-994. doi: 10.1002/cncr.33986. Epub 2021 Oct 22.
PMID: 34679188DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas H. Brandon PhD
- Organization
- Moffitt Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Brandon, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 26, 2016
Study Start
October 24, 2016
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
November 4, 2022
Results First Posted
September 16, 2021
Record last verified: 2022-11