Status:
WITHDRAWN
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pediatric Cancer
Eligibility:
All Genders
2-12 years
Phase:
PHASE2
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 rand...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01828502
Start Date
October 1 2013
End Date
June 1 2016
Last Update
October 29 2014
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
2
Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
3
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
4
Nemours Children's Hospital
Orlando, Florida, United States, 32827