Clinical trial NCT02945787: Spanish-Language Smoking Cessation Trial
Official title: Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Spanish speaking
self-help
tobacco abstinence
public health
Forever Free
Stop Smoking for Good
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Florida Department of Health
First posted: 2016-10-26
Enrollment: 1417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Tobacco Abstinence at 6 Months
timeFrame: 6 months
measure: Percentage of Participants With Tobacco Abstinence at 12 Months
timeFrame: 12 months
measure: Percentage of Participants With Tobacco Abstinence at 18 Months
timeFrame: 18 months
measure: Percentage of Participants With Tobacco Abstinence at 24 Months
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.