Brain NeoplasmNCT01503086
Computer Training Program for Younger Patients With a Brain Tumor Who Underwent Radiation Therapy
A study testing Cognitive Assessment, Computer-Assisted Cognitive Training and Psychosocial Assessment and Care in people with Brain Neoplasm and Recurrent Brain Neoplasm, run by Children's Oncology Group at 28 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Brain Neoplasm, Recurrent Brain Neoplasm
- What is being tested?
- Cognitive Assessment, Computer-Assisted Cognitive Training and Psychosocial Assessment and Care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 30 Jul 2014to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States27 sites
Albany Medical Center
Albany, New York, 12208
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Medical University of South Carolina
Charleston, South Carolina, 29425
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Blank Children's Hospital
Des Moines, Iowa, 50309
Duke University Medical Center
Durham, North Carolina, 27710
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Nemours Children's Hospital
Orlando, Florida, 32827
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Seattle Children's Hospital
Seattle, Washington, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Brain Neoplasm, Recurrent Brain Neoplasm
- Being tested
- Cognitive Assessment, Computer-Assisted Cognitive Training, Psychosocial Assessment and Care, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive AssessmentProcedure or surgery
Ancillary studies
Computer-Assisted Cognitive TrainingOther
Receive computer-assisted cognitive training
Psychosocial Assessment and CareProcedure or surgery
Also called Psychosocial Care/Assessment
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cognitive Assessment; Other: Computer-Assisted Cognitive Training; Procedure: Psychosocial Assessment and Care; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Procedure: Cognitive Assessment; Other: Computer-Assisted Cognitive Training; Procedure: Psychosocial Assessment and Care; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 9 weeks of starting training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study start30 Jul 2014
- Primary completion31 Dec 2024
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kristina K Hardy, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503086
- Sponsor's protocol ID
- ACCL10P1
- Other IDs
- NCI-2012-00112, COG-ACCL10P1, CDR0000721387, ACCL10P1, COG-ACCL10P1, ACCL10P1, U10CA095861, UG1CA189955
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2011
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT01503086
- Acronym / sponsor ID
- ACCL10P1
- Conditions
- Brain Neoplasm, Recurrent Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jul 2014 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (interactive training program) | Experimental | Procedure: Cognitive Assessment, Other: Computer-Assisted Cognitive Training, Procedure: Psychosocial Assessment and Care, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 | Procedure: Cognitive Assessment, Other: Computer-Assisted Cognitive Training, Procedure: Psychosocial Assessment and Care, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive AssessmentAncillary studies | Procedure or surgery | Arm I (interactive training program), Arm II (non-adaptive training program) |
| Computer-Assisted Cognitive TrainingReceive computer-assisted cognitive training | Other | Arm I (interactive training program), Arm II (non-adaptive training program) |
| Psychosocial Assessment and CareAlso: Psychosocial Care/AssessmentAncillary studies | Procedure or surgery | Arm I (interactive training program), Arm II (non-adaptive training program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (interactive training program), Arm II (non-adaptive training program) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (interactive training program), Arm II (non-adaptive training program) |
Primary outcome
Intervention Compliance
Time frame: Up to 9 weeks of starting training
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina K Hardy principal investigator
Children's Oncology Group
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Assessment, Computer-Assisted Cognitive Training and Psychosocial Assessment and Care in people with Brain Neoplasm and Recurrent Brain Neoplasm, run by Children's Oncology Group at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Compliance (time frame: Up to 9 weeks of starting training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.