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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:2 - 12
Updated:11/8/2014
Start Date:October 2013
End Date:June 2016
Contact:Lauren Bello, MPH
Email:lauren.bello@epi.usf.edu
Phone:813-396-9569

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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.

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.

- 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.
We found this trial at
10
sites
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Fort Myers, FL
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Green Bay, Wisconsin 54301
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Orlando, FL
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Pensacola, Florida 32504
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St. Petersburgh, Florida 33701
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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