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

University of South Florida

Status and phase: Withdrawn; Phase 2

Conditions: Pediatric Cancer

Treatments: Behavioral: Cotinine Education; Behavioral: Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01828502

SCUSF 1201

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Active Intervention

Experimental group

Description:

Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip.

Treatment:

Behavioral: Education

Behavioral: Cotinine Education

Education only

Other group

Description:

Those randomized to the education only group will receive only the education about secondhand smoke exposure.

Treatment:

Behavioral: Education