Reduction of Environmental Tobacco Smoke (ETS) Exposure In Pediatric Cancer Patients
N/A
17 Years
Both
Cancer
Trial Information
Reduction of Environmental Tobacco Smoke (ETS) Exposure In Pediatric Cancer Patients
160 St. Jude families with a cancer patient who meets eligibility criteria will be enrolled
on the study. Eligible St. Jude patients must be 17 years of age or younger at the time of
enrollment. They must also be at least one month from initial diagnosis and in active
treatment. The patient cannot currently be using tobacco, and he/she must live with at
least one cigarette smoking adult who smokes in his/her presence. Both smoking and
non-smoking parents are eligible to participate. The inclusion of non-smoking parents
reflects the primary objective of the proposed study to reduce ETS exposure in the child's
environment. We will evaluate the efficacy of an ETS intervention by using a randomized
controlled trial design that incorporates an experimental intervention group (ETS) and a
standard care control group (SCC). Parents in the SCC group will receive the standard
advice with no additional intervention. The experimental group will participate in a three
month, multi-component behavioral program focused on the reduction of the cancer patient's
ETS exposure. The program will consist of three bi-weekly face-to-face coaching sessions
followed by three bi-weekly telephone coaching sessions that will occur within the first
three months following enrollment onto the study. Although telephone counseling sessions
will be offered for parents who are not available in person, the face-to-face sessions are
encouraged as much as possible. Parents in this group will receive physician feedback
letters acknowledging their participation and progress at the start and end of the coaching
phase, as well as, a follow-up telephone contact at five months. Self-report and biological
measures will be obtained from all families during clinic visits at baseline and at three,
six, nine, and twelve months. Reported ETS exposure and the child's urine cotinine levels
will serve as the primary dependent variables. Other psychosocial and health outcomes will
also be assessed. Children 10 years of age and older will complete a brief ETS exposure
questionnaire that asks them to report on exposure in their environment. Parents in each
group will be paid $10 for each set of study forms they answer. The total amount that a
parent in the control group may receive is $50. Parents in the ETS intervention program
will also receive $12.50 for each face-to-face and telephone coaching session in which they
take part. The telephone follow-up call occurring at five months will not be compensated.
The total amount that a parent in the ETS intervention group may receive is $125. Patients
will receive a $10 hospital gift voucher for each urine sample they provide. The total
amount that a patient may receive is $50 to $60. At the end of the study, parents who were
assigned to the standard advice control group may receive the ETS intervention program
without charge, if they so choose. Also, parents in both groups may choose to receive
feedback about their child's urine cotinine results at the completion of the study.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
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.
Outcome Time Frame:
Parent self-reports and patient's urine cotinine levels will be assessed at Baseline, 3, 6, 9, and 12 months
Safety Issue:
No
Principal Investigator
Vida Tyc, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
SMOKN5
NCT ID:
NCT00766766
Start Date:
September 2002
Completion Date:
June 2010
Related Keywords:
- Cancer
- Environmental Tobacco Exposure
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
