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

This study has been withdrawn prior to enrollment.
(The study was closed due to poor accrual. No patients were enrolled.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01828502
First received: March 28, 2013
Last updated: October 28, 2014
Last verified: October 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.


Enrollment: 0
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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828502

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
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: October 28, 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 October 29, 2014