Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
2 Years
12 Years
Both
Pediatric Cancer
Trial Information
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
OBJECTIVES:
The primary objective of this study is to determine if providing urine cotinine feedback to
caregivers in conjunction with standard education will be more effective than education
alone in reducing patient SHS exposure.
The secondary objectives of this study are:
To determine whether urine cotinine feedback in conjunction with education provided to the
caregiver is more effective in changing parental smoking behavior compared to education
alone.
As an exploratory measure we will collect history and physical exam data to follow patient's
clinical complications during the study to determine if patients with a decrease in SHS
exposure also have a decrease in clinical complications.
Inclusion Criteria:
- Age ≥ 2 years and ≤ 12 years at the time of study entry.
- Currently undergoing treatment for cancer at the time of enrollment, at least 28
days post diagnosis and up to 16 weeks after a diagnosis.
- The child must reside 5 days a week with a household smoker (defined as a person who
smokes greater than 10 cigarettes daily).
- Child must be potty trained.
- Parent/Legal Guardian ≥ 18 years of age.
- Parent/Legal Guardian who accompanies the child to the first visit must accompany the
child to all other visits. This person does not need to be the household smoker, but
must be willing to educate the smoker on results at the visit and take the education
handout home to them.
- Parent/Legal Guardian must have a working phone to complete the week 5 follow-up
phone call.
- Able and willing to sign informed consent/assent.
- Signed HIPAA compliant research authorization.
Exclusion Criteria:
- Planned hospitalization within 3 days of any scheduled study visit (due to the urine
cotinine measurement representing the previous 48-72 hours of tobacco exposure.
- Inability to perform the initial cotinine test.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Change in urine cotinine level
Outcome Description:
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
Outcome Time Frame:
4 weeks after baseline visit
Safety Issue:
No
Principal Investigator
Marisa Couluris, DO
Investigator Role:
Study Chair
Investigator Affiliation:
University of South Florida
Authority:
United States: Federal Government
Study ID:
SCUSF 1201
NCT ID:
NCT01828502
Start Date:
Completion Date:
June 2016
Related Keywords:
- Pediatric Cancer
- Cotinine
- Secondhand Smoke Exposure (SHSE)
- Secondhand Smoke (SHS)
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