Pediatric Cancer
Conditions
Keywords
Cotinine, Secondhand Smoke Exposure (SHSE), Secondhand Smoke (SHS)
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.
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.
Interventions
BEHAVIORALEducation
Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented.
BEHAVIORALCotinine 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.
Sponsors
National Cancer Institute (NCI)
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine cotinine level | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Smoking Behavior | 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 | 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. |
Countries
United States
Outcome results
None listed