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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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
No
Vida Tyc, PhD
Principal Investigator
St. Jude Children's Research Hospital
United States: Institutional Review Board
SMOKN5
NCT00766766
September 2002
June 2010
Name | Location |
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St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |