Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:50 AM
Study NCT ID:
NCT05466994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2022-07-18
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 Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory Questionnaires', '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. Score scales (0-4) 0-Never/4 Almost Always'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric ALL', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.', 'detailedDescription': 'Primary Objective:\n\n•To assess the efficacy of SpellBound\'s AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial.\n\nSecondary Objectives:\n\nTo assess the effect 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 the 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 a questionnaire designed by MD Anderson Cancer Center Child Life team.\n* Outpatient opioid consumption reported at 30, 60, and 90 days\n* Outpatient pain scores reported at 30, 60, and 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 major surgery for cancer 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. Have never taken opioids or have had no daily opioid use within the last 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\n * The 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. Patients with any daily opioid use within 30 days before surgery.\n2. History of documented peripheral neuropathy secondary to cancer treatment\n3. Inability to demonstrate an understanding of the game from English instructions\n4. Any additional concerns based on the study physicians' assessments"}, 'identificationModule': {'nctId': 'NCT05466994', 'briefTitle': 'A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)', '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 Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)', 'orgStudyIdInfo': {'id': '2022-0336'}, 'secondaryIdInfos': [{'id': 'NCI-2022-05979', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Reporting Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1(Spellbound)', 'description': "Participants will play the game using the iPad's standard camera, which will show you your hospital room and the decals as they appear in the real world.", 'interventionNames': ['Other: IPAD']}, {'type': 'OTHER', 'label': 'Group 2 (Spellbound)', 'description': 'Participants will play the game using augmented reality', 'interventionNames': ['Other: Augmented Reality']}], 'interventions': [{'name': 'IPAD', 'type': 'OTHER', 'description': 'Participant will play a game through (standard camera) participants will be able to the hospital room and decals as they appear in the real world', 'armGroupLabels': ['Group 1(Spellbound)']}, {'name': 'Augmented Reality', 'type': 'OTHER', 'description': 'Participants will play a game through (devices camera and application) let us participants view the real world', 'armGroupLabels': ['Group 2 (Spellbound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Juan Cata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}