Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT04544618
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will employ a single-blind randomized design (1:1 randomization; stratified according to surgery type \\[with vs. without reconstruction\\] and whether or not neoadjuvant chemotherapy was received; stratification will designate equal proportions of participants with these characteristics across each of the two study groups).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PROMIS emotional distress- anxiety', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'PROMIS anxiety questionnaire'}, {'measure': 'PROMIS emotional distress- depression', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'PROMIS depression questionnaire'}, {'measure': 'PROMIS global health', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'PROMIS global health questionnaire'}, {'measure': 'PROMIS fatigue', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'PROMIS fatigue questionnaire'}, {'measure': 'PROMIS emotional support', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'PROMIS emotional support questionnaire'}, {'measure': 'PROMIS pain intensity', 'timeFrame': '5 days and 30 days', 'description': 'PROMIS pain intensity questionnaire'}, {'measure': 'Peritraumatic Distress Inventory (PDI)', 'timeFrame': 'Baseline and 5 days', 'description': 'PDI questionnaire'}, {'measure': 'Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)', 'timeFrame': 'Baseline and 30 days', 'description': 'PC-PTSD-5 questionnaire'}, {'measure': 'Brief Resilient Coping Scale (BRCS)', 'timeFrame': 'Baseline, 5 days, and 30 days', 'description': 'BRCS questionnaire'}], 'primaryOutcomes': [{'measure': 'Self-reported impressions of the virtual reality operating room simulation', 'timeFrame': 'Baseline', 'description': "Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention"}, {'measure': 'Self-reported impressions of the virtual reality operating room simulation', 'timeFrame': '5 days', 'description': "Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention"}], 'secondaryOutcomes': [{'measure': 'NCCN Distress Thermometer', 'timeFrame': 'Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days', 'description': 'VAS self-reported distress on a scale of 0-10'}, {'measure': 'NCCN Anxiety Thermometer', 'timeFrame': 'Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days', 'description': 'VAS self-reported anxiety on a scale of 0-10'}, {'measure': 'iGroup Presence Questionnaire', 'timeFrame': 'Immediately after the intervention', 'description': 'Assessing the sense of presence experienced by participants in the virtual environment'}, {'measure': 'Preoperative Intrusive Thoughts Inventory (PITI)', 'timeFrame': 'Baseline and up to 2 weeks after baseline on day of scheduled surgery', 'description': 'PITI questionnaire'}, {'measure': 'Amsterdam Preoperative Anxiety Information Scale (APAIS)', 'timeFrame': 'Baseline and up to 2 weeks after baseline on day of scheduled surgery', 'description': 'APAIS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative anxiety', 'Cancer', 'Virtual reality', 'Feasibility', 'Pilot study'], 'conditions': ['Anxiety State']}, 'referencesModule': {'references': [{'pmid': '38743939', 'type': 'DERIVED', 'citation': 'El-Gabalawy R, Sommer JL, Hebbard P, Reynolds K, Logan GS, Smith MSD, Mutter TC, Mutch WA, Mota N, Proulx C, Gagnon Shaigetz V, Maples-Keller JL, Arora RC, Perrin D, Benedictson J, Jacobsohn E. An Immersive Virtual Reality Intervention for Preoperative Anxiety and Distress Among Adults Undergoing Oncological Surgery: Protocol for a 3-Phase Development and Feasibility Trial. JMIR Res Protoc. 2024 May 14;13:e55692. doi: 10.2196/55692.'}, {'pmid': '38231570', 'type': 'DERIVED', 'citation': 'Sommer JL, Reynolds K, Hebbard P, Smith MSD, Mota N, Mutch WAC, Maples-Keller J, Roos L, El-Gabalawy R. Preoperative Virtual Reality to Expose Patients With Breast Cancer to the Operating Room Environment: Feasibility and Pilot Case Series Study. JMIR Form Res. 2024 Jan 17;8:e46367. doi: 10.2196/46367.'}]}, 'descriptionModule': {'briefSummary': 'This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce anxiety/distress in cancer surgery patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, and the inclusion of a treatment as usual group, and effects of the intervention on symptoms of anxiety/distress. Results of this study will inform the design of an upcoming larger-scale RCT to assess the efficacy of this intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over the age of 18\n* Can speak and read English\n* Has a cancer diagnosis\n* Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)\n\nExclusion Criteria:\n\n* Those who do not meet any inclusion criteria\n* Those who are not competent to provide informed consent (e.g., due to cognitive impairment)\n* Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)'}, 'identificationModule': {'nctId': 'NCT04544618', 'briefTitle': 'Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study', 'orgStudyIdInfo': {'id': 'HS23957 (H2020:247)'}, 'secondaryIdInfos': [{'id': '322523 340300 2000', 'type': 'OTHER_GRANT', 'domain': 'New Frontiers'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.', 'interventionNames': ['Device: Virtual reality operating room simulation']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual group', 'description': 'Participants will receive standard of care with no additional intervention aside from information received at their surgical oncology appointment and optional preoperative education classes (available to all patients).'}], 'interventions': [{'name': 'Virtual reality operating room simulation', 'type': 'DEVICE', 'description': "The virtual reality simulation will begin with the participant sitting on a hospital bed wearing the virtual reality headset and holding the controllers. Participants will be oriented to the environment and provided with an explanation of how to navigate through the simulation (for approximately 2 minutes). Next, participants will explore the virtual operating room for a minimum of 5 minutes, or longer if desired. Following the exploration period, the scripted portion of the simulation will be begin. Here, participants will be taken through the mock anesthetic induction process (the virtual anesthetist will speak to the patient and walk them through the steps and the virtual nurse will assist). The simulation ends after the virtual oxygen mask is placed over the participant's mouth and the screen darkens.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 3N4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Jordana Sommer, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Renée El-Gabalawy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Kristin Reynolds, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Pamela Hebbard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Natalie Mota, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Alan Mutch, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Thomas Mutter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Rakesh Arora, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}, {'name': 'Jessica Maples-Keller, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jordana Sommer', 'investigatorAffiliation': 'University of Manitoba'}}}}