Spanish-Language Smoking Cessation Trial

Smoking Cessation Clinical Trial

Official title:

Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945787
• Other study ID #: MCC-18633
• Secondary ID: R01CA199143
• Status: Completed
• Phase: N/A
• Start date: October 24, 2016
• Est. completion date: July 2020

Study information

• Verified date: November 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1417
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Spanish-Language Version of the Stop Smoking for Good
Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.
• NCI-Produced Spanish-language Self-help Booklet
Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.

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	Florida Department of Health, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website