- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850954
Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households
Project CASA: Promoting Smoke-Free Indoor Air Policy in Mexican American Households
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Reduction in secondhand smoke exposure: The study will distinguish if a tailored intervention designed to address the needs of the target group will reduce objectively and subjectively measured secondhand smoke exposure of nonsmokers in Mexican American (MA) households.
Ia. Develop tailored fotonovelas for intervention implementation. II. Smoking cessation: The study will identify if a tailored intervention designed to address the needs of the target group will help the primary smokers in the household quit smoking.
III. Stages of change: The study will identify if the proposed intervention will have a significant impact on the primary smoker(s) progression through the stages of smoking cessation.
IV. Knowledge and attitudes: The study will identify if the proposed intervention will result in better knowledge and changed attitudes towards secondhand smoke exposure among members of MA households (smokers and nonsmokers) compared to standard care.
V. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke would improve perceived health.
OUTLINE: Participants are assigned to 1 of 2 groups based on smoking status.
GROUP I (SMOKERS): Participants receive smoking cessation intervention materials based on transtheoretical model of change (TTM).
GROUP II (NON-SMOKERS): Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting.
Participants are followed up at 6 and 12 months to assess for home air quality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Live in the targeted Mexican American neighborhoods.
- Can read Fotonovelas in English and Spanish.
- Access to telephone.
- Smoker in household (adult [18+] person living in the household who smokes INSIDE at least one cigarette a week).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (smoking cessation)
Participants receive smoking cessation intervention materials based on TTM.
|
Ancillary studies
Receive smoking cessation materials based on TTM
Other Names:
|
|
Experimental: Group II (informational)
Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting.
|
Ancillary studies
Receive information on secondhand smoke and supporting smoker in quitting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of nicotine measured at 6 month post intervention
Time Frame: 6 months after treatment
|
Method of analysis is a pre-post test analysis of covariance, ANCOVA, using a linear regression model (PROC REG in SAS).
In this analysis, the prevalence of nicotine levels at the 6-month follow-up compared between conditions while controlling for baseline nicotine levels.
Second hand smoke (SHS) exposure based on objective monitoring of SHS in each household (in the kitchen and TV room) over a 7-day period.
A small, lightweight (16 gram) passive nicotine monitor used to measure exposure to nicotine.
|
6 months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2006-0440 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-02502 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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