Brain Neoplasm Clinical Trial
Official title:
Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
Verified date | May 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 71 |
Est. completion date | March 30, 2027 |
Est. primary completion date | March 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | Albany Medical Center | Albany | New York |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Tampa General Hospital | Tampa | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parent-rated executive function using the Metacognition subscales from the Behavior Rating Inventory of Executive Function (BRIEF) | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Working memory (WM) using the Metacognition subscales from (BRIEF) | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Executive function using the Groton Maze Learning task of the CogState battery | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | WM by the one-back task from CogState | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | WM by Digit Span from Wechsler Intelligence Scales | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Visual working memory using Spatial Span from Wechsler Scale | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Visual memory using Dot Location from Children's Memory Scale | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Technical feasibility based on the item responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Adherence based on total number of training sessions completed | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Satisfaction based on the item responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Other | Ease of use based on the item responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Up to 6 months post training completion | |
Primary | Proportion of patients with intervention compliance | Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). | Up to 9 weeks of starting training |
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