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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


Regulatory Point of Contact
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Principal Investigator
Anne-Marie Langevin