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SCUSF 1201 Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer

Study Chair:
Marisa Couluris, D.O.
Status:
Approved by NCI
Activation Date: 5/13/2013

NCT01828502

Study 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.

Subject Selection

Inclusion Criteria:

  • Patients must be between 2 and 12 years of age 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 must be at least 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.

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 cotinine test.

 

 

Link to Abstract

Please note, this information may change if the protocol is amended. Please refer to the current protocol for the most accurate information such as a complete list of the eligibility requirements.

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