Your session is about to expire
← Back to Search
Behavioural Intervention
Computer-Assisted Cognitive Training for Brain Tumor
N/A
Waitlist Available
Led By Kristina K Hardy
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post training completion
Awards & highlights
Study Summary
This trial looks at whether an adaptive computer training program can help improve cognition in young brain tumor patients who have undergone radiation therapy.
Who is the study for?
This trial is for young patients with brain tumors who have finished radiation therapy within the last 4 months. They need to have a caregiver, access to a phone, and understand English. Patients with traumatic brain injury before their tumor diagnosis, pontine glioma, IQ < 70 or severe disabilities that prevent computer use are not eligible.Check my eligibility
What is being tested?
The study compares an adaptive computerized cognitive training program against a non-adaptive one to see if they can improve mental function and quality of life after brain radiation therapy in younger patients with brain tumors.See study design
What are the potential side effects?
Since this trial involves cognitive training programs rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience fatigue or frustration during the exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor is either new or has worsened and hasn't been treated with CRT.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months post training completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post training completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with intervention compliance
Other outcome measures
Adherence based on total number of training sessions completed
Ease of use based on the item responses to the 13-item Feasibility Interview
Executive function using the Groton Maze Learning task of the CogState battery
+8 moreSide effects data
From 2022 Phase 2 trial • 26 Patients • NCT0201796456%
Neutrophil count decreased
44%
White blood cell decreased
28%
Lymphocyte count decreased
28%
Platelet count decreased
4%
Meningitis
4%
Other, Progression Of Medulloblastoma
4%
Hearing impaired
4%
Leukocytosis
4%
Hypernatremia
4%
Hypokalemia
4%
Febrile neutropenia
4%
Death NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Eligible Patients (Combination Chemotherapy)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (non-adaptive training program)Experimental Treatment5 Interventions
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.
Group II: Arm I (interactive training program)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial Assessment and Care
2007
Completed Phase 3
~370
Cognitive Assessment
2011
Completed Phase 2
~1320
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,629 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,082 Total Patients Enrolled
Kristina K HardyPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain tumor located in the pons.I have someone willing to help me during my treatment.I have a phone and can be contacted.I cannot use a computer due to a physical disability.My brain tumor is either new or has worsened and hasn't been treated with CRT.I completed my chemoradiotherapy (CRT) less than 4 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (interactive training program)
- Group 2: Arm II (non-adaptive training program)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it presently feasible for participants to join this experiment?
"This trial is currently enlisting participants, as evidenced by the data hosted on clinicaltrials.gov. This study was created in November of 2013 and most recently revised in late 2022."
Answered by AI
Are there any specific criteria for being accepted into this clinical experiment?
"Inclusion criteria for this trial necessitates that participants have cancer and are aged between 6 to 16. The project is looking for approximatively 71 individuals."
Answered by AI
Does this experiment accept elderly participants aged 75 and older?
"The ideal candidates for this trial are children who have reached the age of 6 but not yet turned 16."
Answered by AI
How many venues is this inquiry accessible in?
"This trial is accepting patients at 23 different medical centres, such as Providence Sacred Heart Medical Center and Children's Hospital in Spokane, Wake Forest University Health Sciences in Winston-Salem, and Children's National Medical Center in Washington."
Answered by AI
What is the capacity for enrollees in this clinical trial?
"Correct. Clinicaltrials.gov reveals that this research trial is enrolling participants, with the initial posting being on November 18th 2013 and last update being on November 28th 2022. 71 people are expected to join from 23 clinics across the country."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger