Skip to main content
OpenTrials
Completed

NCT Number: NCT02611076

Smoking-cessation: A Spanish-Language Clinical Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Stop Smoking for Good Intervention in Spanish (SS-SP)

Behavioral

Assessments will occur at six-month intervals, through 24 months.

Usual care (UC)

Behavioral

Assessments will occur at six-month intervals, through 24 months.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • James and Esther King Biomedical Research Program
  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Nov 20, 2015
Registry last updated
Jan 19, 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.

Published trials that share one or more normalized conditions with this study.