Status:
ACTIVE_NOT_RECRUITING
Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Neoplasm
Recurrent Brain Neoplasm
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief 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 patient...
Detailed Description
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),...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01503086
Start Date
July 30 2014
End Date
March 31 2026
Last Update
December 5 2025
Active Locations (28)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316