Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 7:27 PM
Study NCT ID:
NCT06635434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary; Percent of enrolled patients who activated/used the app during the PACU stay', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Feasibility measured as activation/usage of the app recorded by the device ID for each patient'}], 'secondaryOutcomes': [{'measure': 'Total time spent playing on the AR app during the PACU stay', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Length of time (minutes) of app usage recorded by the device ID for each patient'}, {'measure': 'Recorded responses about pain assessment from the app', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Pain scale score in English or Spanish through the app'}, {'measure': 'Recorded responses about nausea/vomit assessment from the app', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Baxter animated retching scale score in English or Spanish through the app'}, {'measure': 'Inpatient opioid consumption', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Calculated as morphine equivalent dose of all opioids given'}, {'measure': 'Length of stay', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Total time (minutes) spent in the PACU after surgery'}, {'measure': 'Quality of life survey', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'PedsQL survey administered to child and/or adult caregiver stratified by age'}, {'measure': 'Rate of opioid prescription', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record'}, {'measure': 'Patient/caregiver satisfaction survey', 'timeFrame': 'immediately after the intervention/procedure/surgery', 'description': 'Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea?'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '27258079', 'type': 'BACKGROUND', 'citation': 'Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.'}, {'pmid': '27802492', 'type': 'BACKGROUND', 'citation': 'Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.'}]}, 'descriptionModule': {'briefSummary': 'In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 7-17 years old\n* child able to provide assent, and a legal guardian able to provide informed consent\n* current diagnosis of pediatric cancer\n* undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization\n* prescribed or expected to be prescribed opioids during inpatient perioperative period\n* sufficient mental capacity to comprehend and interact with the game in English or Spanish.\n\nExclusion Criteria:\n\n* the inability to play with the SpellBound app from English or Spanish instructions\n* daily opioid use within 30 days prior to surgery\n* any concerns from the treatment team.'}, 'identificationModule': {'nctId': 'NCT06635434', 'briefTitle': 'An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALTality, Inc.'}, 'officialTitle': 'Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients', 'orgStudyIdInfo': {'id': '1R43DA057744-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43DA057744-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmented reality-enabled pain assessment deployed on a mobile', 'description': 'Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration', 'interventionNames': ['Device: AR Pain assessment']}], 'interventions': [{'name': 'AR Pain assessment', 'type': 'DEVICE', 'description': 'Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration', 'armGroupLabels': ['Augmented reality-enabled pain assessment deployed on a mobile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Christina York', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ALTality, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Pediatric cancer diagnoses are rare and by definition could identify individual patients and violate patient privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALTality, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}