Smoking-cessation: A Spanish-Language Clinical Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | October 15, 2015 |
| End Date: | May 2020 |
Expanding the Reach of a Validated Smoking-Cessation Intervention: 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.
appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and
remaining smoke-free.
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.
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.
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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Vani Simmons, Ph.D.
Phone: 813-745-4374
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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