Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-23 @ 8:49 PM
Study NCT ID:
NCT02995603
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Experience and Acceptance of Horizontal Rotation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System', 'timeFrame': '1 hour', 'description': 'Comparison of mean scores of Short Form State/Trait Anxiety Inventory (STAI) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation System'}, {'measure': 'Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System', 'timeFrame': '1 hour', 'description': 'Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation'}, {'measure': 'Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System', 'timeFrame': '1 year', 'description': 'Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Rotation'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.', 'detailedDescription': 'Study participants will be asked to attend the clinic on two separate occasions. Each session will last less than one hour. Patients will be asked to complete validated psychometric surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their (baseline) motion sickness, before and after each session. They will then be rotated 3-4 times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to 45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is 9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients will again complete the questionnaire assessing their anxiety levels and motion sickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of cancer, any stage\n2. ≥18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) status 0-2\n4. Currently or previously being treated with radiotherapy\n5. Any prior therapy allowed\n6. Willing and able to comply with all study requirements\n7. Must be able to read and complete questionnaires in English\n8. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Mentally impaired patients or patients for whom attaining informed consent would be difficult (including language barriers)\n3. Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo'}, 'identificationModule': {'nctId': 'NCT02995603', 'acronym': 'Nano-X', 'briefTitle': 'Patient Experience and Acceptance of Horizontal Rotation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'Nano-X: Patient Experience and Acceptance of Horizontal Rotation', 'orgStudyIdInfo': {'id': 'Nano-X V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient rotation', 'description': 'Patients will be rotated horizontally, using the Nano-X patient rotation system, and asked to complete validated questionnaires to quantify their experience.', 'interventionNames': ['Device: Nano-X patient rotation']}], 'interventions': [{'name': 'Nano-X patient rotation', 'type': 'DEVICE', 'description': 'Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.', 'armGroupLabels': ['Patient rotation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Michael Jackson, A/Prof', 'role': 'CONTACT', 'email': 'michael.jackson2@health.nsw.gov.au', 'phone': '+61 2 9382 8873'}, {'name': 'Meg Schneider, BN', 'role': 'CONTACT', 'email': 'meg.schneider@health.nsw.gov.au', 'phone': '+61 2 9382 2507'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}], 'centralContacts': [{'name': 'Shona Silvester', 'role': 'CONTACT', 'email': 'shona.silvester@sydney.edu.au', 'phone': '+61 2 86271185'}], 'overallOfficials': [{'name': 'Paul Keall, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sydney'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prince of Wales Hospital, Sydney', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}