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

University of South Florida

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Pediatric Cancer

Interventions

EducationBEHAVIORAL

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 EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks after baseline visit

Secondary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks after baseline visit

Data from ClinicalTrials.gov

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