Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
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ClinicalTrials.gov Identifier: NCT01828502 |
Recruitment Status :
Withdrawn
(The study was closed due to poor accrual. No patients were enrolled.)
First Posted : April 10, 2013
Last Update Posted : October 29, 2014
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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 |
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 (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 |

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.
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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.
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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. |
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828502
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 |
Study Chair: | Marisa Couluris, DO | University of South Florida |
Responsible Party: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT01828502 |
Other Study ID Numbers: |
SCUSF 1201 |
First Posted: | April 10, 2013 Key Record Dates |
Last Update Posted: | October 29, 2014 |
Last Verified: | October 2014 |
Cotinine Secondhand Smoke Exposure (SHSE) Secondhand Smoke (SHS) |