Reduction of Environmental Tobacco Smoke (ETS) Exposure In Pediatric Cancer Patients

NCT00766766 | Completed

• 2 other identifiers: SMOKN55R01CA085406
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

SMOKN5 is aimed at studying ways to reduce environmental tobacco smoke (ETS) for children who are being treated for cancer. The study includes St. Jude parents whose child lives with at least one adult smoker who exposes the child to ETS, also called "secondhand smoke." We are comparing two groups of parents to see which group results in lower ETS exposure levels for the child being treated with cancer. The first group will receive the standard information and advice usually given to parents about secondhand smoke. The second group will take part in a new program designed to reduce ETS. The primary objective of the study is to determine the efficacy of an environmental tobacco smoke intervention compared to the standard care control condition, as measured by parent report. Parents in each group answer questions about ETS exposure. We also collect urine samples from the child at specific time points throughout the study. The urine is tested to measure the amount of cotinine, a metabolite of nicotine. Measuring cotinine tells us how much nicotine from tobacco smoke the child has been exposed to. Children who are at least 10 years of age or older will also be asked to complete a set of questions pertaining to their tobacco use history and ETS exposure from others. This will occur at the same five time points in which the parent completes his/her portion. The study will last about 12 months for each participating family. Parents who take part in the study may learn how to lower their child's exposure to ETS, and this may, in turn, lower the child's chances of having ETS-related health problems.

Conditions

Cancer

Keywords

Environmental Tobacco Exposure

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of an Environmental Tobacco Smoke (ETS) exposure intervention compared to a Standard Care Control (SCC) condition, as measured by parent report.

  Parent self-reports and patient's urine cotinine levels will be assessed at Baseline, 3, 6, 9, and 12 months

Study Arms (2)

1

EXPERIMENTAL

Experimental Intervention Group

Behavioral: Health Risk and Behavioral Skills Coaching Sessions; Behavioral: Telephone Coaching Sessions; Behavioral: Physician Feedback Letter

2

NO INTERVENTION

Standard Care Control

Interventions

Health Risk and Behavioral Skills Coaching Sessions BEHAVIORAL

Health Risk and Behavioral Skills Coaching Sessions

1

Telephone Coaching Sessions BEHAVIORAL

Telephone Coaching Sessions

1

Physician Feedback Letter BEHAVIORAL

Physician Feedback Letter

1

Eligibility Criteria

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

You may qualify if:

• Patient Characteristics
• SJCRH patient with primary diagnosis of any type of cancer.
• ≤17 years of age at the time of enrollment.
• At least one month from diagnosis and in active treatment at the time of enrollment.
• Does not currently use tobacco (defined as abstinence from tobacco during the 30 days preceding the screening assessment as based on patient, 10-17 years of age,and/or parent report).
• Lives with at least one cigarette smoking adult (must be parent or family member/relative) who smokes in their presence (i.e. in the home/hotel, in the same room, in the car, etc) by parent report. Smoking adults will be defined as those who have smoked cigarettes in the past 30 days, per parent report.
• Patient, 10-17 years of age, reads and speaks English.
• Parent/Step-Parent/Legal Guardian Characteristics:
• Reads and speaks English.
• Informed consent by institutional guidelines.

You may not qualify if:

• Patient Characteristics
• Patients with relapse or recurrence of disease within the past month or those with progressive disease.
• Patients in medical crisis as determined by consultation with the child's primary care physician.
• Patients with poor prognosis high-risk malignancies not likely to survive 12 months from diagnosis as documented by child's primary care physician.
• On bone marrow transplant service.
• Parent/Step-Parent/Legal Guardian Characteristics:
• Patient's social worker or primary care physician will be consulted prior to parents being approached for enrollment to ensure that the parent is not currently in crisis or distress or have another disabling condition that would preclude participation.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sean Phipps, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: September 1, 2002
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

US (1)