Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT04821466
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR for Symptom Control and Wellbeing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort interrupted time series study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative patient experience of VR interventions', 'timeFrame': 'Time 60 minutes', 'description': 'Patients to answer: Were there any negative side effects of the VR session?'}, {'measure': 'Repeat VR experiences', 'timeFrame': '12 Months', 'description': 'ESAS-r QoL Scores (0 to 10) will be collected each time a patient uses the experience to consider the effect repeat exposure has on wellbeing and symptoms. 0 = No symptoms to 10 = Worst Symptom'}], 'primaryOutcomes': [{'measure': 'ESAS-r Quality of Life Scores', 'timeFrame': 'Time 0 & Time 60 minutes', 'description': 'Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom'}], 'secondaryOutcomes': [{'measure': 'Quantitative clinician experience of VR intervention', 'timeFrame': 'Time 60 minutes', 'description': 'Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)'}, {'measure': 'Quantitative clinician experience of VR intervention', 'timeFrame': 'Time 60 minutes', 'description': 'Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality'], 'conditions': ['Oncology', 'End Stage Cancer', 'Palliative Care', 'Hematologic Malignancy']}, 'referencesModule': {'references': [{'pmid': '39886490', 'type': 'DERIVED', 'citation': "Moon NO, Henstridge-Blows JR, Sprecher EA, Thomas E, Byfield A, McGrane J. 'Godrevy Project': virtual reality for symptom control and well-being in oncology and palliative care - a non-randomised pre-post interventional trial. BMJ Oncol. 2023 Dec 18;2(1):e000160. doi: 10.1136/bmjonc-2023-000160. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* \\> 18 years of age\n* Inpatient at RCHT know to the palliative care team\n* Able to consent\n* Able to speak and understand the English language\n* Able to use the virtual reality system\n* Able to complete ESAS-r Questionnaire\n\nExclusion criteria\n\n* \\<18 years of age\n* Patient unable to consent\n* Patient unable to speak English\n* Unable to use the virtual reality system (e.g. visually impaired)\n* Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)'}, 'identificationModule': {'nctId': 'NCT04821466', 'briefTitle': 'VR for Symptom Control and Wellbeing', 'organization': {'class': 'OTHER', 'fullName': 'Royal Cornwall Hospitals Trust'}, 'officialTitle': 'The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients', 'orgStudyIdInfo': {'id': '2021.RCHT.07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Headset', 'description': 'VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing', 'interventionNames': ['Device: Virtual Reality Headset to provide a Virtual Reality Experience']}], 'interventions': [{'name': 'Virtual Reality Headset to provide a Virtual Reality Experience', 'type': 'DEVICE', 'description': 'Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.', 'armGroupLabels': ['Virtual Reality Headset']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3HD', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'overallOfficials': [{'name': 'Niall O Moon, BMBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Cornwall Hospitals Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}