ACCL10P1, Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
Study ID: STU 022014-019
Patients will have baseline testing to see if they are eligible to be randomized on the study. Randomization will take place after baseline testing has been performed within approximately 3 months ((+-)1 month) of completing CRT. Patients meeting criteria for randomization will be assigned to either arm a (adaptive testing) or arm B (non-adaptive testing). Randomization will be stratified by age ([Less Than]8 years versus [GreaterThanorequalTo]8 years), treatment intensity (whole brain vs. focal radiation) and Coach (a versus B). The treatment on this study involves completing 25 cognitive training sessions on the computer at home. The treatment on this study takes about 5 to 9 weeks. if patients do not have a computer at home, one will be provided to them during the study so they can complete the training sessions. The treatment on this study that is experimental is the cognitive training. The training sessions will start about 3 months after radiation therapy is completed. each training session will last about 15 to 45 minutes. There will be 3 to 5 sessions per week for 5 to 9 weeks. Patients will also have some testing of cognitive function (ability to think, learn and remember) at 3 timepoints in this study: before patients start the cognitive training (1.5 hours), soon after they complete the cognitive training (45 minutes), and about 6 months after they complete the cognitive training (45 minutes). This testing will include questions and problems given by an examiner as well as a computerized test of patients' memory, called CogState. if the tests suggest there may be a problem, the study doctor will share these results with patients and discuss whether or not additional tests are needed. Parent(s) will also complete some questionnaires about patients and their family at these same timepoints. The questionnaires will take approximately 1 hour to complete. During treatment, patients will be contacted by a treatment coach once a week by phone. The coach will answer questions and be sure patients are not having problems completing the training.
1. The patient must be aged 6 to 16 years at diagnosis, inclusive. 2. Patient must be newly diagnosed (ie, not relapsed) with a brain tumor. 3. Patient is within 3 (+ or -) 1 calendar months following completion of cranial radiation therapy (CRT). 4. Patient is currently being followed at 1 of the participating sites (includes UT Southwestern Medical Center) and may be enrolled on a COG therapeutic study. 5. The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT). 6. The patient must have access to a telephone and phone number where they can be reached. 7. The patient and caregiver must have reading, speaking and listening comprehension of English. 8. All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution[?]s policy). 9. All institutional, FDA, and NCI requirements for human studies must be met.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Naomi Joan Winick
CHILDRENS ONCOLOGY GROUP OPERATIONS CTR