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

This study has been completed.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00850954
First received: February 24, 2009
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

Objectives:

Exposure to secondhand smoke (SHS) is a major public health problem in the United States. Studies conducted in this country and internationally have irrefutably shown the causal role of passively inhaled cigarette smoke in development and exacerbation of acute and chronic diseases.

The intervention will be delivered primarily in the form of fotonovelas based on smoking cessation programs previously developed, and the national telephone quit line specifically designed to serve Latino users. The intervention addresses the needs of Mexican American families (youth, middle-aged, and older adults). The evaluation study will be a randomized, controlled trial with assessments at baseline and at 6 and 12 months post-treatment. Up to 125 households will be recruited from the established cohort of Mexican American households located in the Houston metropolitan area.

The objectives for this study are as follows:

1. 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 MA households.

1a. Develop tailored Fotonovelas for intervention implementation

2. 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.

3. 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.

4. 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.

5. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke would improve perceived health.


Condition Intervention
Cancer
Behavioral: Printed Materials
Behavioral: Fotonovelas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Project CASA: Promoting Smoke-Free Indoor Air Policy in Mexican American Households

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Monitoring Secondhand Smoke (SHS): Nicotine Exposure Levels [ Time Frame: Baseline and 6 Month Follow Up, up to 12 months ] [ Designated as safety issue: No ]
    SHS exposure based on objective monitoring of SHS in each household (in the kitchen and TV room) over a 7-day period. Passive nicotine monitor used in each home to measure exposure to nicotine which is commonly used as a marker for SHS exposure, and validate self-reported smoking. The method of analysis will be a pre-post test analysis of covariance, ANCOVA, using a linear regression model (PROC REG in SAS).


Enrollment: 168
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention Tools + Materials for Smokers Behavioral: Printed Materials

Pamphlets:

Specific materials for non-smokers and motivated/not motivated smokers.

Behavioral: Fotonovelas
Illustrated storybooks.
Intervention Tools + Materials for Non-Smokers Behavioral: Printed Materials

Pamphlets:

Specific materials for non-smokers and motivated/not motivated smokers.

Behavioral: Fotonovelas
Illustrated storybooks.

Detailed Description:

If you choose to take part in this behavioral study, each household will be randomly assigned to one of 2 study groups. Each study group will receive a different set of learning tools. You will have an equal chance of being assigned to each group.

During Visit 1, researchers will come to your home and explain the study. You will receive a detailed description of the project's goals and procedures. The study staff member will ask you a series of questions to find out about the people who live in your home. The interview will take about 40-50 minutes. Project staff will set up 2 air quality monitors in your home. Each monitor is about the size of a deck of cards. The monitors will be used to measure the air quality in the home.

During Visit 2 (about 1 week after Visit 1), the air quality monitors will be collected. Both participating adult members of the household will be surveyed (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes. In addition, learning tools will be provided.

About 6 months later, you will have 2 more follow-up visits. During Visit 3, project staff will again set up 2 new air quality monitors in your home. Seven (7) days later (Visit 4), project staff will return to the home to collect the monitors. The same participating adult members of the household will be surveyed again (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes.

In another 6 months (12 months from the start of the study), you will have the last 2 follow-up visits. During Visit 5, project staff will again set up 2 air quality monitors in your home. Seven (7) days later (Visit 6), project staff will return to your home to collect the monitors. The same participating adult members of the household will be surveyed again (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes. At the end of this visit, you will have completed the study. Up to 125 households will take part in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study smoke-free indoor air policy of Mexican American households in Houston Metropolitan area.

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)

Exclusion Criteria:

  • None other than not meeting inclusion criteria.
  • Is there an age limit? No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850954

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Flight Attendant Medical Research Institute
Investigators
Principal Investigator: Alex Prokhorov, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00850954     History of Changes
Other Study ID Numbers: 2006-0440
Study First Received: February 24, 2009
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Cancer
Smoke
Mexican American
Indoor Air Policy
Secondhand smoke
SHS
Smoking cessation programs
Smokers
Tobacco
Nicotine
Chronic diseases
Transtheoretical model of change
TTM

ClinicalTrials.gov processed this record on September 18, 2014