N/A
N=45
Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Brain Neoplasm · Recurrent Brain Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01503086 ↗Enrolled (actual)
45
Serious AEs
—
Results posted
Dec 2025
Primary outcome: Primary: Intervention Compliance — 0.39; 0.50 Proportion of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Assessment (Procedure); Computer-Assisted Cognitive Training (Other); Psychosocial Assessment and Care (Procedure); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Compliance |
0.39; 0.50 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01503086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.