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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00112 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| COG-ACCL10P1 | |||
| CDR0000721387 | |||
| ACCL10P1 | Other Identifier | Children's Oncology Group | |
| COG-ACCL10P1 | Other Identifier | DCP | |
| ACCL10P1 | Other Identifier | CTEP | |
| U10CA095861 | U.S. NIH Grant/Contract | View source | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (interactive training program) | Experimental | 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. |
|
| Arm II (non-adaptive training program) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Assessment | Procedure | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Compliance | Intervention compliance is defined as at least 80% of computerized training sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). Will report the proportion of eligible, randomized patients who meet the compliance definition by arm with corresponding 95% confidence intervals. | Up to 9 weeks of starting training |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Working Memory (WM) Using the Metacognition Subscales From (BRIEF) |
Inclusion Criteria:
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT
Patient enrollment must occur within 4 calendar months following 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:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina K Hardy | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Alfred I duPont Hospital for Children |
There were 45 total enrollments, among which 3 were never assigned to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2018 |
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| Computer-Assisted Cognitive Training | Other | Receive computer-assisted cognitive training |
|
| Psychosocial Assessment and Care | Procedure | Ancillary studies |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
Descriptive/summary statistics will be provided. |
| Up to 6 months post training completion |
| 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 |
| WM by the One-back Task From CogState | Descriptive/summary statistics will be provided. | Up to 6 months post training completion |
| WM by Digit Span From Wechsler Intelligence Scales | Descriptive/summary statistics will be provided. | Up to 6 months post training completion |
| Visual Working Memory Using Spatial Span From Wechsler Scale | Descriptive/summary statistics will be provided. | Up to 6 months post training completion |
| Visual Memory Using Dot Location From Children's Memory Scale | Descriptive/summary statistics will be provided. | Up to 6 months post training completion |
| 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 |
| Adherence Based on Total Number of Training Sessions Completed | Descriptive/summary statistics will be provided. | Up to 6 months post training completion |
| 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 |
| 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 |
| Wilmington |
| Delaware |
| 19803 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| FG001 | 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. |
| FG002 | No Assigned Arm | Patients never assigned to a treatment arm. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | No Assigned Arm | Patients never assigned to a treatment arm. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Compliance | Intervention compliance is defined as at least 80% of computerized training sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training). Will report the proportion of eligible, randomized patients who meet the compliance definition by arm with corresponding 95% confidence intervals. | Per protocol, the analysis includes all eligible, randomized participants without a medical event during cognitive training (cancer relapse/progression, death, removal from protocol therapy due to physician's determination in the patient's best interest, development of seizures or other change in functional status, or starting or changing the dose of psychostimulants). dose of psychostimulants)." | Posted | Number | 95% Confidence Interval | Proportion of Participants | Up to 9 weeks of starting training |
|
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| ||||||||||||||||||||||||||||
| Other Pre-specified | Parent-rated Executive Function Using the Metacognition Subscales From the Behavior Rating Inventory of Executive Function (BRIEF) | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Working Memory (WM) Using the Metacognition Subscales From (BRIEF) | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Executive Function Using the Groton Maze Learning Task of the CogState Battery | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | WM by the One-back Task From CogState | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | WM by Digit Span From Wechsler Intelligence Scales | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Visual Working Memory Using Spatial Span From Wechsler Scale | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Visual Memory Using Dot Location From Children's Memory Scale | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Technical Feasibility Based on the Item Responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adherence Based on Total Number of Training Sessions Completed | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Satisfaction Based on the Item Responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Ease of Use Based on the Item Responses to the 13-item Feasibility Interview | Descriptive/summary statistics will be provided. | Not Posted | Up to 6 months post training completion | Participants |
Serious and other [non-serious] adverse events were not collected or assessed as part of the study.
Serious and other [non-serious] adverse events were not collected or assessed as part of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 21 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 21 | 0 | 0 | 0 | 0 |
| EG002 | No Assigned Arm | Patients never assigned to a treatment arm. | 0 | 3 | 0 | 0 | 0 | 0 |
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Must obtain prior sponsor approval
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 6262411500 | resultsreportingcoordinator@childrensoncologygroup.org |
| Nov 17, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|