Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Lay Description
This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.
Category
- Cancers and Other Neoplasms
- Child Health
- Nervous System
- IRB Number
- 20140435HU
- NCT Number
- NCT01503086
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 6 Years and 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
-
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT
- Note: COG therapeutic study participation is not required for ACCL10P1 enrollment
-
Patient enrollment must occur within 4 calendar months following completion of CRT
- Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
- 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)
- The patient must have access to a telephone and phone number where they can be reached
- The patient and caregiver must have reading, speaking and listening comprehension of English
- 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)
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
- Patients with pontine glioma are not eligible
- Patients with an estimated survival of less than one year are not eligible
- Patients with a history of traumatic brain injury prior to tumor diagnosis are not eligible
- Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial
- Patients with full-scale intelligence quotient (IQ) < 70 per previous testing OR existing diagnosis of/educational classification as a student with an intellectual disability are not eligible
Study Design
Arm Groups
Study Contact
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Principal Investigator
Anne-Marie Langevin