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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01828502
• Other study ID #: SCUSF 1201
• Status: Withdrawn
• Phase: Phase 2
• First received: March 28, 2013
• Last updated: October 28, 2014
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Education
Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented.
• Cotinine Education
Those randomized to the active intervention will also be provided with education utilizing the cotinine test strip in conjunction with the education from the EPA.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine cotinine level	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.	4 weeks after baseline visit	No
Secondary	Change in Self-Reported Smoking Behavior	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.	4 weeks after baseline visit	No
Secondary	Number of medical complications	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.	4 weeks after baseline visit	No

External Links

•   SunCoast CCOP Research Base