Finding studies
Finding studies
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Lead
St. Jude Children's Research Hospital
With
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.
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
