Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy

PRIMARY OBJECTIVES:

I. To assess the feasibility of a home-based, computerized, cognitive training program for
patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT),
treated in multiple Children Oncology Group (COG) institutions.

EXPLORATORY OBJECTIVES:

I. To estimate the effect size of this program on measures of attention and working memory in
patients with brain tumors treated with CRT in order to design a definitive large-scale
clinical trial.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (intervention): Patients undergo a home-based, computerized, interactive training
program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program
contains twelve visually engaging and interesting exercises that target skills involving
visual-spatial and verbal working memory (WM). The program is adaptive in a way that each
difficulty task is automatically adjusted on a trial-by-trail basis to match a patient?s
current WM. Each patient has an interventional coach who has online access to patient's
training sessions and outcomes (pass or fail). Coaches are able to modify the training
sequence or make suggestions to patients and/or parents about how progress can be maximized.
Coaches also have telephone meetings with patients and/or families once a week to ensure
compliance, track progress, provide feedback, and answer questions that arise during
training.

ARM II (control): Patients undergo a home-based, computerized, interactive, non-adaptive
training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient
also has an interventional coach as in arm I. Patients in both arms complete a brief
neuropsychological/behavioral assessment comprising the Wechsler Intelligence Scale for
Children (WIS-IV), the Children's Memory Scale (CMS), and the California Verbal Learning
Test-Children's Version (CVLT-C) at baseline, after completion of study, and at 6 months
after completion of study. Additionally, parents complete a parent-report questionnaire to
gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social
and functional impairment. Parents and children also complete surveys about the program
regarding technical feasibility, adherence, ease-of-use, and satisfaction.

After completion of study treatment, participants are followed up within 3 weeks, then at 6
months.

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