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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pediatric Cancer
• Intervention / Treatment: Behavioral: Education; Behavioral: Cotinine Education

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I. DuPont Hospital for Children
  • Florida
    • Fort Myers, Florida, United States, 33908
      • Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hospital
    • Pensacola, Florida, United States, 32504
      • Nemours Children's Clinic
    • St. Petersburgh, Florida, United States, 33701
      • All Children's Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • St. Vincent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Intervention; Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip.	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.; Behavioral: 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.
Other: Education only; Those randomized to the education only group will receive only the education about secondhand smoke exposure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Marisa Couluris, DO, University of South Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Cotinine; Secondhand Smoke Exposure (SHSE); Secondhand Smoke (SHS)
• Other Study ID Numbers: SCUSF 1201