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

This study is currently recruiting participants.
Verified March 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01828502
First received: March 28, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Pediatric Cancer
Behavioral: Education
Behavioral: Cotinine Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change in urine cotinine level [ Time Frame: 4 weeks after baseline visit ] [ Designated as safety issue: No ]
    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:
  • Change in Self-Reported Smoking Behavior [ Time Frame: 4 weeks after baseline visit ] [ Designated as safety issue: No ]
    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.

  • Number of medical complications [ Time Frame: 4 weeks after baseline visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 236
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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 and up to 16 weeks after a 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828502

Contacts
Contact: Lauren Bello, MPH 813-396-9569 lauren.bello@epi.usf.edu
Contact: Angelina Fink, MPH 813-396-9245 angelina.fink@epi.usf.edu

Locations
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Ande Wrightson    302-651-5584      
Principal Investigator: E. Anders Kolb, MD         
United States, Florida
Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Molly Arnstrom    239-343-6959      
Principal Investigator: Emad Salman, MD         
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Kelly Waldrep    904-697-2508      
Principal Investigator: Eric Sandler, MD         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Kristen Gibbs    407-650-7652      
Principal Investigator: Ramamoorthy Nagasubramanian, MD         
Nemours Children's Clinic Recruiting
Pensacola, Florida, United States, 32504
Contact: Dannah McCormick    850-505-4794      
Principal Investigator: Jeffrey Schwartz, MD         
All Children's Hospital Recruiting
St. Petersburgh, Florida, United States, 33701
Contact: Jennifer Flanary    727-767-6466      
Principal Investigator: Gregory Hale, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Denise Fife    813-844-7829      
Principal Investigator: Cameron K Tebbi, MD         
United States, Wisconsin
St. Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Christy Gilchrist    920-433-8272      
Principal Investigator: Anthony Jaslowski, MD         
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01828502     History of Changes
Other Study ID Numbers: SCUSF 1201
Study First Received: March 28, 2013
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Keywords provided by University of South Florida:
Cotinine
Secondhand Smoke Exposure (SHSE)
Secondhand Smoke (SHS)

ClinicalTrials.gov processed this record on April 17, 2014