Clinical trial NCT05947045: Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Official title: Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: Radiotherapy
Brain tumor
Cognitive training
Virtual Reality
Working memory
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The objectives of this study are:

Primary Objective:

• To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.

Secondary Objectives:

* To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad.
* To evaluate patterns of cortical activation (oxygenated and deoxygenated hemoglobin responses) pre- and post- cognitive training in the virtual reality setting and on an iPad.

The investigators will use a randomized, single blind (psychology examiner), parallel group design (cognitive training via iPad versus virtual reality) to test hypotheses about behavioral and neurophysiological changes associated with cognitive training in childhood cancer survivors. The investigators will recruit patients who are being treated for a BT with radiotherapy. Patients will participate in study sessions in the Psychology Clinic during routine visits to St. Jude for radiotherapy. fNIRS studies will be conducted with participants randomized to both the virtual reality and iPad groups pre- and post- Cogmed training sessions. The time period between pre- and post-cognitive assessments will be 2 to 4 weeks for both virtual reality and iPad groups.

Participants will be enrolled until 30 patients initiating radiotherapy for a BT are evaluable, with approximately 20 randomized to the virtual reality group and 10 to the iPad group. The investigators expect to recruit and screen up to 45 patients to ascertain 30 eligible participants.

Enrollment and assessment will be completed approximately 18 months after the study begins. Imaging data will be processed approximately two years after the study begins, and study findings will be disseminated within three years after the study begins.

Data management and statistical analysis will be provided locally by the Department of Psychology, the Neuroimaging Division of Radiological Sciences and the Biostatistics Department at St. Jude Children's Research Hospital

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Participation Rate
timeFrame: After approach for enrollment, an average of 3 weeks after starting radiation therapy
measure: Adherence
timeFrame: At the completion of radiation therapy, an average of 6 weeks after enrollment
measure: Side Effects
timeFrame: At the completion of radiation therapy, an average of 6 weeks after enrollment
Secondary outcomes:
measure: Neurobehavioral
timeFrame: After completion of post-training assessment, an average of 8 weeks after enrollment
measure: Cerebral Hemodynamics
timeFrame: After completion of post-training assessment, an average of 8 weeks after enrollment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Andrew Heitzer, PhD, ABPP-CN
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Heather Conklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: