RECRUITING

Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors

Conditions

Brain Tumor Radiotherapy Cognitive training Virtual Reality Working memory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are: 1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects? 2. Will cognitive training via virtual reality provide neurocognitive benefits? 3. Will there be predictable changes in brain activity as measured by neuroimaging? Findings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.

Official Title

Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors

Quick Facts

Study Start:2023-06-22

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05947045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Initiating radiotherapy for a BT * Between 8-22 years of age at the time of enrollment * English or Spanish as the primary language * Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines * Participant willing to take part in required aspects of Cogmed training	* Significant impairment in global intellectual functioning (estimated or full scale IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \[NOPP\]) * History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness * Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training) * Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation) * Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation/planning but not daily treatment)

Inclusion Criteria

Exclusion Criteria

* Initiating radiotherapy for a BT
* Between 8-22 years of age at the time of enrollment
* English or Spanish as the primary language
* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
* Participant willing to take part in required aspects of Cogmed training

* Significant impairment in global intellectual functioning (estimated or full scale IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \[NOPP\])
* History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness
* Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)
* Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)
* Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation/planning but not daily treatment)

Contacts and Locations

Study Contact

Heather Conklin, PhD

CONTACT

901-595-3585

referralinfo@stjude.org

Principal Investigator

Andrew Heitzer, PhD, ABPP-CN

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Heather Conklin, PhD

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

Andrew Heitzer, PhD, ABPP-CN, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
Heather Conklin, PhD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22

Study Completion Date2025-03

Study Record Updates

Study Start Date2023-06-22

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Radiotherapy
Brain tumor
Cognitive training
Virtual Reality
Working memory

Additional Relevant MeSH Terms

Brain Tumor