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

• ClinicalTrials.gov Identifier: NCT01828502
• Recruitment Status: Withdrawn
• First Posted: April 10, 2013
• Last Update Posted: October 29, 2014
• Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of South Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Cancer	Behavioral: Education; Behavioral: Cotinine Education	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
• Study Start Date: October 2013
• Estimated Primary Completion Date: June 2016
• Estimated Study Completion Date: June 2016

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in urine cotinine level [ Time Frame: 4 weeks after baseline visit ]
   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.

Secondary Outcome Measures :

1. Change in Self-Reported Smoking Behavior [ Time Frame: 4 weeks after baseline visit ]
   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.
2. Number of medical complications [ Time Frame: 4 weeks after baseline visit ]
   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

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

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.

Contacts and Locations

Locations

United States, Delaware

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States, 19803

United States, Florida

Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States, 33908

Nemours Children's Clinic

Jacksonville, Florida, United States, 32207

Nemours Children's Hospital

Orlando, Florida, United States, 32827

Nemours Children's Clinic

Pensacola, Florida, United States, 32504

All Children's Hospital

St. Petersburgh, Florida, United States, 33701

Tampa General Hospital

Tampa, Florida, United States, 33606

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

United States, Wisconsin

St. Vincent Hospital

Green Bay, Wisconsin, United States, 54301

Sponsors and Collaborators

University of South Florida

National Cancer Institute (NCI)

Investigators

• Study Chair: Marisa Couluris, DO; University of South Florida

More Information

Additional Information:

SunCoast CCOP Research Base 

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT01828502
• Other Study ID Numbers: SCUSF 1201
• First Posted: April 10, 2013
• Last Update Posted: October 29, 2014
• Last Verified: October 2014

Keywords provided by University of South Florida:

Cotinine; Secondhand Smoke Exposure (SHSE); Secondhand Smoke (SHS)