Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Pediatric Cancer

In brief

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.

Key facts

Study ID

NCT01828502

Run by

University of South Florida

People needed

0

Starts

2013-10-01

Expected to finish

2016-06-01

Last updated by the study team

2014-10-29

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Nemours Children's Clinic — Pensacola, Florida, United States
• All Children's Hospital — Saint Petersburgh, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Columbia University Medical Center — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• St. Vincent Hospital — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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