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The study was closed due to poor accrual. No patients were enrolled.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip. |
|
| Education only | Other | Those randomized to the education only group will receive only the education about secondhand smoke exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urine cotinine level | 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. | 4 weeks after baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Smoking Behavior | 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. | 4 weeks after baseline visit |
| Number of medical complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisa Couluris, DO | University of South Florida | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida |
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| Cotinine Education | Behavioral | 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. |
|
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. |
| 4 weeks after baseline visit |
| Fort Myers |
| Florida |
| 33908 |
| United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Nemours Children's Clinic | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | Saint Petersburgh | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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