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

NCT01828502 | Withdrawn Phase 2 DMC

• 1 other identifier: SCUSF 1201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Pediatric Cancer

Keywords

Cotinine; Secondhand Smoke Exposure (SHSE); Secondhand Smoke (SHS)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Self-Reported Smoking Behavior

  4 weeks after baseline visit

• Number of medical complications

  4 weeks after baseline visit

Study Arms (2)

Active Intervention

EXPERIMENTAL

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

Behavioral: Education; Behavioral: Cotinine Education

Education only

OTHER

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

Behavioral: Education

Interventions

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.

Active Intervention; Education only

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.

Active Intervention

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

Saint Petersburgh, Florida, 33701, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Marisa Couluris, DO

  University of South Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 10, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

US (10)