Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT04069702
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2019-08-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.kelleher@duke.edu', 'phone': '9194163405', 'title': 'Sarah Kelleher, PhD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected during the one-time study visit which lasted approximately 90 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility, Assessed by Examining Number of Participants Accrued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Feasibility was assessed by examining number of participants accrued.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Feasibility will be assessed by examining protocol adherence (\\>80% adherence to the protocol \\[defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure\\])', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility, Assessed by Number of Participants With Completed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 minutes', 'description': 'Feasibility will be assessed by examining completed data (\\>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability Using the Client Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 minutes', 'description': 'This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With VR Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': "Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '1.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-, post-VR session, approximately 90 minutes', 'description': 'Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'spread': '2.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-VR session assessment', 'description': 'Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Tension as Measured With the Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.70', 'spread': '12.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.', 'description': 'Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Distress as Measured With the Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.60', 'spread': '13.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.', 'description': 'Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post-VR session, approximately 90 minutes', 'description': 'Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.60', 'spread': '16.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre- and post-VR session, approximately 90 minutes', 'description': 'Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.\n\nVR Blue: VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain Right Now', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-30', 'size': 90100, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-29T13:04', 'hasProtocol': True}, {'date': '2021-07-30', 'size': 195343, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-13T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2019-08-23', 'resultsFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-27', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility, Assessed by Examining Number of Participants Accrued', 'timeFrame': '6 months', 'description': 'Feasibility was assessed by examining number of participants accrued.'}, {'measure': 'Feasibility, Assessed by Examining Number of Participants With >80% Adherence to the Protocol', 'timeFrame': '30 minutes', 'description': 'Feasibility will be assessed by examining protocol adherence (\\>80% adherence to the protocol \\[defined in this study as the degree to which participants are willing and able to complete the 30-minute VR exposure\\])'}, {'measure': 'Feasibility, Assessed by Number of Participants With Completed Data', 'timeFrame': '90 minutes', 'description': 'Feasibility will be assessed by examining completed data (\\>80% data collected at the study appointment, including pre-, midpoint, and post-VR assessments)'}, {'measure': 'Acceptability Using the Client Satisfaction Questionnaire', 'timeFrame': '90 minutes', 'description': 'This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of their post-VR session assessment.'}, {'measure': 'Number of Participants With VR Side Effects', 'timeFrame': '30 minutes', 'description': "Safety of the VR protocol will be assessed based on participants' report of VR side effects, such as motion sickness, dizziness, headache, nausea, or other negative physical reactions"}], 'secondaryOutcomes': [{'measure': 'Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)', 'timeFrame': 'Pre-, post-VR session, approximately 90 minutes', 'description': 'Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "pain right now" from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.'}, {'measure': 'Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale', 'timeFrame': 'Pre-VR session assessment', 'description': 'Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score.'}, {'measure': 'Change in Tension as Measured With the Visual Analog Scale (VAS)', 'timeFrame': 'Pre-, post-VR session. Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.', 'description': 'Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no tension at all, 100=maximum tolerable tension. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.'}, {'measure': 'Change in Distress as Measured With the Visual Analog Scale (VAS)', 'timeFrame': 'Pre- and post-VR session, Full study visit starting at pre-VR and ending at Post-VR is approximately 90 minutes.', 'description': 'Visual Analog Scale (VAS) items are rated on a 0-100 scale. 0=no stress at all, 100=maximum tolerable stress. An average of the responses at each time-point were used to create a single score of change from pre-VR session to post-VR session.'}, {'measure': "Change in Pain Catastrophizing as Measured With the Coping Strategies Questionnaire's Pain Catastrophizing Subscale", 'timeFrame': 'Pre- and post-VR session, approximately 90 minutes', 'description': 'Items will be rated on a scale ranging from 0=never do to 6=always do when in pain. An average of the responses to these items is used to create a single score of change from pre-VR session to post-VR session.'}, {'measure': 'Change in Pain Self-efficacy as Measured Using Items Adapted From the Self-efficacy for Pain Management Subscale of the Chronic Pain Self-Efficacy Scale', 'timeFrame': 'Pre- and post-VR session, approximately 90 minutes', 'description': 'Self-efficacy will be measured using items adapted from the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. Items are rated on a 10-point scale ranging from 10=very uncertain to 100=very certain. Scores are averaged to give an overall value of change from pre-VR session to post-VR session for pain self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.medrxiv.org/content/10.1101/2022.01.04.21268275v1', 'label': 'Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial'}]}, 'descriptionModule': {'briefSummary': "Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress.\n\nThe proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.\n\nThe investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.", 'detailedDescription': "Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. Unfortunately, analgesics are not uniformly effective and often are associated with poorly tolerated side effects (e.g., constipation, nausea, sedation). There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients.\n\nVR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress. VR may be particularly likely to positively impact cognitive pathways by changing pain-related cognitions (e.g., decreasing pain catastrophizing, increasing self-efficacy for pain control). VR-based interventions have the potential to alter these negative ways of thinking, and advanced cancer patients with persistent pain and pain-related distress may be particularly likely to benefit.\n\nThe proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. That study found that exposure to a 30-minute virtual underwater/sea environment (VR Blue) produced significant increases in pain tolerance for thermal pain stimuli compared to control conditions. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress.\n\nThe investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.\n\nThe long-term goal of this research is to improve quality of life in advanced colorectal cancer patients by decreasing pain, tension and distress. This project will provide preliminary data that will be used to inform and optimize development of a multi-session VR protocol to be tested in patients with advanced stage colorectal cancer that could be generalizable to other palliative care populations with pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18-85\n* a diagnosis of stage IV colorectal cancer\n* clinical pain documented in medical chart (\\>4 on a 0-10 scale) and confirmed on the day of their study appointment (\\>4 on a 0-10 scale)\n* being able to read and speak English\n* self-reported normal or corrected to normal vision\n* self-reported normal hearing\n\nExclusion Criteria:\n\n* a serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records\n* a medical condition that contraindicates safe participation in the study (e.g., recent myocardial infarction)\n* visual, hearing, or cognitive impairment that will interfere with the patient's ability to engage in the intervention"}, 'identificationModule': {'nctId': 'NCT04069702', 'acronym': 'VR Blue', 'briefTitle': 'Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pilot Testing a Virtual Reality Protocol for Improving Pain and Pain-Related Distress in Patients With Advanced Stage Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Pro00103248'}, 'secondaryIdInfos': [{'id': 'U2CNR014637', 'link': 'https://reporter.nih.gov/quickSearch/U2CNR014637', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR Blue', 'description': 'VR Blue is a protocol for patients with advanced stage colorectal cancer who experience persistent pain. Participants will complete a single 30-minute laboratory-based virtual reality underwater/sea environment (VR Blue) session. VR Blue is an immersive computer-generated environment featuring calming scenic graphics and relaxing nature music.', 'interventionNames': ['Behavioral: VR Blue']}], 'interventions': [{'name': 'VR Blue', 'type': 'BEHAVIORAL', 'description': 'VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.', 'armGroupLabels': ['VR Blue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sarah A Kelleher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will become available after completion of the study and when summary data are published and otherwise made available. From this timepoint, data will be available for 5 years.', 'ipdSharing': 'YES', 'description': 'As part of the NIH data sharing directive, de-identified data from this study will be transferred to the PCRC De-Identified Data Repository located at the University of Colorado. The PCRC fully supports the Final NIH Statement on Sharing Research Data, and will assist all investigators and study personnel to ensure their compliance. Consistent with OMB Circular A-110 and subsequent NIH Grants Policy Statements, the PCRC will provide access to all de-identified data collected as part of PCRC-supported investigations, insofar as access is consistent with IRB/CHR rules, local, state, and Federal laws and regulations, and the HIPAA Privacy Rule.', 'accessCriteria': 'The Principal Investigator will work with requesters and IRBs on a case by case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Palliative Care Research Cooperative Group', 'class': 'NETWORK'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}