Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 6:13 AM
Study NCT ID:
NCT05589857
Status:
WITHDRAWN
Last Update Posted:
2024-10-23
First Post:
2022-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-05', 'size': 342553, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-21T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No Patients Enrolles', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'through completion of study, an average of 1 year', 'description': 'Quality of life assessment: Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.', 'detailedDescription': 'Primary Objective:\n\nTo assess the efficacy of SpellBound\'s AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.\n\nSecondary Objectives:\n\nTo assess the impact of AR versus non-AR control technology in pediatric oncology patients, including:\n\n* Inpatient opioid use\n* Average daily inpatient pain score\n* Number of opioid requests during hospital stay\n* Inpatient PedsQL (quality of life) questionnaire score\n* Ambulation/"out of bed" movement\n* Number days to discharge-ready status\n* Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team\n* Outpatient opioid use reported at 30, 60, 90 days.\n* Outpatient pain scores reported at 30, 60, 90 days\n* Outpatient PedsQL scores reported at 30, 60, and 90 days\n* Potential adverse events related to the use of AR (i.e., falls).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ages 5-15\n2. English and Spanish-speaking parents/legal guardians and patients\n3. Undergoing surgery requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night\n4. Expected to be prescribed postoperative inpatient opioids\n5. Prescribed daily opioids for pain for a period equal to or longer than 30 days before surgery.\n6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.\n7. Both the child and a legal guardian are willing and able to provide informed consent.\n\nThe range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (\\>15 years of age) were disinterested in the interactive game.\n\nExclusion Criteria:\n\n1. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery\n2. Inability to demonstrate an understanding of the game from English instructions\n3. Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital"}, 'identificationModule': {'nctId': 'NCT05589857', 'briefTitle': 'A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use', 'orgStudyIdInfo': {'id': '2022-0529'}, 'secondaryIdInfos': [{'id': 'NCI-2022-08945', 'type': 'OTHER', 'domain': 'NCI- CTRP Clinical Trial Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Spellbound)', 'description': "Participants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.", 'interventionNames': ['Device: IPAD']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Spellbound)', 'description': 'Participants will play the game using augmented reality.', 'interventionNames': ['Device: Augmented Reality']}], 'interventions': [{'name': 'IPAD', 'type': 'DEVICE', 'description': "Participants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.", 'armGroupLabels': ['Group 1 (Spellbound)']}, {'name': 'Augmented Reality', 'type': 'DEVICE', 'description': 'Participants will play a game through (device camera and application) that add virtual or digital characters and items that let participants view the real world.', 'armGroupLabels': ['Group 2 (Spellbound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Juan Cata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}