Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
- Conditions
- Pediatric Cancer
- Interventions
- Behavioral: EducationBehavioral: Cotinine Education
- Registration Number
- NCT01828502
- Lead Sponsor
- University of South Florida
- Brief Summary
RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.
PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Intervention Education Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip. Active Intervention Cotinine Education Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip. Education only Education Those randomized to the education only group will receive only the education about secondhand smoke exposure.
- Primary Outcome Measures
Name Time Method Change in urine cotinine level 4 weeks after baseline visit 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.
- Secondary Outcome Measures
Name Time Method Change in Self-Reported Smoking Behavior 4 weeks after baseline visit 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.
Number of medical complications 4 weeks after baseline visit 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.
Trial Locations
- Locations (9)
Nemours Children's Clinic
🇺🇸Pensacola, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
All Children's Hospital
🇺🇸St. Petersburgh, Florida, United States
Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States