Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
NCT ID: NCT01503086
Last Updated: 2025-12-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
45 participants
INTERVENTIONAL
2014-07-30
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (interactive training program)
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 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.
Questionnaire Administration
Ancillary studies
Cognitive Assessment
Ancillary studies
Computer-Assisted Cognitive Training
Receive computer-assisted cognitive training
Psychosocial Assessment and Care
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Arm II (non-adaptive training program)
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 WIS-IV, the CMS, and the 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.
Questionnaire Administration
Ancillary studies
Cognitive Assessment
Ancillary studies
Computer-Assisted Cognitive Training
Receive computer-assisted cognitive training
Psychosocial Assessment and Care
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Questionnaire Administration
Ancillary studies
Cognitive Assessment
Ancillary studies
Computer-Assisted Cognitive Training
Receive computer-assisted cognitive training
Psychosocial Assessment and Care
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Kristina K Hardy
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, 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
Nemours Children's Hospital
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Blank Children's Hospital
Des Moines, Iowa, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2012-00112
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-ACCL10P1
Identifier Type: -
Identifier Source: secondary_id
CDR0000721387
Identifier Type: -
Identifier Source: secondary_id
ACCL10P1
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ACCL10P1
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL10P1
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL10P1
Identifier Type: -
Identifier Source: org_study_id
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