Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-28 @ 4:08 PM
Study NCT ID:
NCT06298357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)', 'description': 'Steps per day measured by a tri-axial accelerometer (Fitbit Flex).'}], 'secondaryOutcomes': [{'measure': 'Minutes of gameplay', 'timeFrame': 'Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.', 'description': 'Minutes of gameplay measured by the Meta Quest headset.'}, {'measure': 'Global Health', 'timeFrame': 'Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.', 'description': 'National Institutes of Health (NIH) PROMIS Global Health Short Form 7+2 survey. The scale consists of 7 items that are summarized into a single score of overall health. Participants respond to items without a recall period on how they would rate their overall health, quality of life, and their physical, mental, and social health, using a 5-point Likert scale with varying response categories.'}, {'measure': 'Forced Expiratory Volume in the first second (FEV1)', 'timeFrame': 'Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.', 'description': 'FEV1 (Liters) by a Spirometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '39714090', 'type': 'DERIVED', 'citation': 'Lai B, Chaviano K, Richman JS, Ahmad M, Wright A, Young R, Davis D, Rimmer JH, Madan-Swain A, Chewning JH. Extended Reality Gaming for Exercise and Mindfulness Throughout Pediatric Cancer Rehabilitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 23;13:e64879. doi: 10.2196/64879.'}]}, 'descriptionModule': {'briefSummary': 'This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>7 years of age\n* medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant or a hospital stay that is anticipated to last for at least 2 weeks\n* a caregiver who can assist the child with the study procedures\n\nExclusion Criteria:\n\n* complete blindness or deafness\n* inability to operate the hand-held controllers\n* susceptible to motion sickness in virtual reality\n* inability to communicate in English'}, 'identificationModule': {'nctId': 'NCT06298357', 'briefTitle': 'Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '300012601'}, 'secondaryIdInfos': [{'id': 'LAIKPRI02012024', 'type': 'OTHER_GRANT', 'domain': 'Kaul Pediatric Research Institute Pilot Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Start', 'description': 'Program starts in the hospital and lasts for 8 weeks after hospital discharge.', 'interventionNames': ['Behavioral: Immediate Start - Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'After 8 weeks after hospital discharge, these participants start the 8 week intervention.', 'interventionNames': ['Behavioral: Delayed Start - Virtual Reality']}], 'interventions': [{'name': 'Immediate Start - Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness. They will start using the headsets in the hospital and then will continue to do so for 8 weeks after hospital discharge.', 'armGroupLabels': ['Immediate Start']}, {'name': 'Delayed Start - Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Participants will receive usual care in the hospital and outside of the hospital for 8 weeks. After the 8 week post-discharge period, participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness for an 8 week period.', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Byron Lai', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}