Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947045
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-06-07
Brief Title:
Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens Research Hospital
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 Childrens Research Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03975 | REGISTRY | NCI Clinical Trial Registration Program | None |