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Behavioural Intervention
Cognitive Training for Brain Cancer
N/A
Recruiting
Led By Andrew Heitzer, PhD, ABPP-CN
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approach for enrollment, an average of 3 weeks after starting radiation therapy
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates feasibility & acceptability of cognitive training via virtual reality & iPad for children with brain tumors undergoing radiotherapy to improve quality of life. Results will inform a larger trial.
Who is the study for?
This trial is for children aged 8-22 undergoing radiotherapy for brain tumors, who speak English or Spanish. They and a parent must agree to participate and follow the study's procedures. It excludes those with an IQ < 70, severe psychiatric conditions, major sensory/motor impairments that affect testing, significant neurological history before their tumor diagnosis, or need for general anesthesia during treatment.
What is being tested?
The study tests cognitive training using either an iPad or virtual reality (VR) to see if VR is feasible and acceptable in this setting. Children will be randomly assigned to one of these methods and undergo cognitive tests plus brain activity exams before and after the intervention to assess potential neurocognitive benefits.
What are the potential side effects?
While not explicitly mentioned, side effects may include discomfort from wearing VR equipment, eye strain from screen use on both iPad and VR devices, possible motion sickness from VR use, and fatigue due to concentration required during cognitive training sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after approach for enrollment, an average of 3 weeks after starting radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approach for enrollment, an average of 3 weeks after starting radiation therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence
Participation Rate
Side Effects
Secondary study objectives
Cerebral Hemodynamics
Neurobehavioral
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality Cogmed TrainingExperimental Treatment1 Intervention
The investigator will be randomizing participants to complete Cogmed training in Virtual Reality.
Group II: IPad Cogmed TrainingActive Control1 Intervention
The investigator will be randomizing participants to complete Cogmed training on an iPad.
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,436 Total Patients Enrolled
Andrew Heitzer, PhD, ABPP-CNPrincipal InvestigatorSt. Jude Children's Research Hospital
Heather Conklin, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
2 Previous Clinical Trials
144 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 8 and 22 years old.I primarily speak English or Spanish.I am willing to participate in Cogmed training.I have had a significant brain-related condition like a stroke or severe head injury before my brain tumor diagnosis.I do not have any major physical or sensory issues that would stop me from completing cognitive tests.I am starting radiotherapy for a brain tumor.I only need sedation for planning my radiation therapy, not for daily treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IPad Cogmed Training
- Group 2: Virtual Reality Cogmed Training
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.
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