View Clinical Trial (Medical Research Study)
Community Outreach and Biomarker Feedback for Smoke-Free Homes
| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55455 |
| Conditions: |
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Smoking Cessation - Tobacco Cessation |
| Purpose: |
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Smoking is widely accepted to cause an increase in an individual's likelihood of developing
cancer and heart disease. The effects of tobacco smoke are not limited to smokers.
Secondhand smoke inhaled by a non-smoker has also been associated with the development of
several illnesses. This study focuses on learning how to make your home smoke-free.
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| Study Summary: |
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This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot
study with the purpose to develop a motivationally enhanced biomarker feedback counseling
protocol and all printed materials to be used in Phase 2. After investigators develop a good
working treatment protocol, an active intervention in smoking homes who live with a child in
their home will be carried out.
Those randomized to the Control Group will receive health education in the form of brochures
detailing the health effects of secondhand smoke and how to make their home smoke free.
Participants randomized to the Treatment Group will receive tobacco-specific biomarker
feedback and personalized motivationally enhanced counseling.
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| Criteria: |
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Inclusion Criteria (adult):
- Age 18 years or older
- Female
- Smoked ≥ 1 cigarettes per day for at least the past 6 months
- Smoked on 20 days or more in the last month
- Smoking status confirmed via cotinine verification strips
- Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
- Will agree to provide a urine sample at study enrollment
- Will also agree to the child providing a urine sample at study enrollment and at
follow-up visits (for children who are not toilet trained, a diaper sample will be
collected in lieu of the urine sample)
- Has a home address
- Has a functioning home phone or cell phone
- Provides written informed consent
Inclusion criteria (child):
- < or = 10 years of age
- Non-smoker -no cigarette use within prior 30 days to enrollment; however
experimentation with smoking (a puff) will not exclude the child
- Lives in the primary home with the adult study participant at least 5 days a week
Exclusion criteria (adult):
- Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy
for smoking cessation
- Planning to move outside of Minnesota within the next 3 months
- Have complete home smoking restrictions currently in place verified by the nicotine
dosimeter
- Currently pregnant
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| NCT ID: |
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NCT01574560 |
| Primary Contact: |
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Principal Investigator
Janet L. Thomas, Ph.D.
Masonic Cancer Center, University of Minnesota
Janet L. Thomas, Ph.D.
Phone: 612-625-0414
Email: jthomas@umn.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Minneapolis, Minnesota 55455
United States
Janet L. Thomas, Ph.D.
Phone: 612-625-0414
Email: jthomas@umn.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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