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Completed

NCT Number: NCT02945787

Spanish-Language Smoking Cessation Trial

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spanish-Language Version of the Stop Smoking for Good

Behavioral

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

Behavioral

Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.

Primary outcomes

  1. Percentage of Participants With Tobacco Abstinence at 6 Months

    Time frame: 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.

  2. Percentage of Participants With Tobacco Abstinence at 12 Months

    Time frame: 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.

  3. Percentage of Participants With Tobacco Abstinence at 18 Months

    Time frame: 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.

  4. Percentage of Participants With Tobacco Abstinence at 24 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Department of Health
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2016
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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