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Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850954
Recruitment Status : Withdrawn
First Posted : February 25, 2009
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies the effect of an intervention program, Project CASA, on smoking cessation and reducing secondhand smoke exposure in Mexican American households. Project CASA, comprising pamphlets and fotonovelas (illustrated storybooks), may provide valuable information to participants on how to improve the air quality in their homes.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Current Smoker Currently Living With Smoker Other: Informational Intervention Behavioral: Smoking Cessation Intervention Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project CASA: Promoting Smoke-Free Indoor Air Policy in Mexican American Households
Actual Study Start Date : August 8, 2006
Actual Primary Completion Date : August 7, 2018
Actual Study Completion Date : August 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (smoking cessation)
Participants receive smoking cessation intervention materials based on TTM.
Behavioral: Smoking Cessation Intervention
Receive smoking cessation materials based on TTM
Other Name: Smoking and Tobacco Use Cessation Interventions

Other: Survey Administration
Ancillary studies

Experimental: Group II (informational)
Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting.
Other: Informational Intervention
Receive information on secondhand smoke and supporting smoker in quitting

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850954


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alexander V Prokhorov M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00850954    
Other Study ID Numbers: 2006-0440
NCI-2019-02502 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006-0440 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No