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

September 26, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Smoking and Tobacco Use Cessation Interventions
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2006

Primary Completion (Actual)

August 7, 2018

Study Completion (Actual)

August 7, 2018

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimated)

February 25, 2009

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

June 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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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