Clinical trial NCT01828502: Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
Official title: Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pediatric Cancer
Keywords: Cotinine
Secondhand Smoke Exposure (SHSE)
Secondhand Smoke (SHS)
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in urine cotinine level
timeFrame: 4 weeks after baseline visit
Secondary outcomes:
measure: Change in Self-Reported Smoking Behavior
timeFrame: 4 weeks after baseline visit
measure: Number of medical complications
timeFrame: 4 weeks after baseline visit
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Fort Myers
country: United States
facility: Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Clinic
state: Florida
city: St. Petersburgh
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Green Bay
country: United States
facility: St. Vincent Hospital
state: Wisconsin
Study officials:
affiliation: University of South Florida
name: Marisa Couluris, DO
role: STUDY_CHAIR
References: