Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-03 @ 6:53 PM
Study NCT ID:
NCT06354595
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Multidimensional Rehabilitation in the Metaverse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-04', 'releaseDate': '2024-07-09'}], 'estimatedResultsFirstSubmitDate': '2024-07-09'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Study System Usability Questionnaire (PSSUQ) Third Edition', 'timeFrame': '4th week', 'description': "The questionnaire includes three dimensions: usefulness, information quality, interface quality, and one overall evaluation item, totaling 20 items. Each item is rated on a scale from 'strongly disagree' to 'strongly agree' with scores ranging from 1 to 5. A higher score indicates higher user satisfaction."}, {'measure': 'System Usability Scale (SUS)', 'timeFrame': '4th week', 'description': "Used to evaluate user experience, employing the Likert 5-point scale method, consisting of 10 questions. Questions 1, 3, 5, 7, and 9 are positively worded, while questions 2, 4, 6, 8, and 10 are negatively worded. The validity of the scale is 0.85. The SUS is scored on a percentage scale. When the questionnaire score is above 70, the product is considered 'good,' and above 50 is considered 'okay."}], 'secondaryOutcomes': [{'measure': 'Semi-structured interview', 'timeFrame': '4th week', 'description': "Through interviews, conducting interviews with colorectal cancer patients on the theme of 'platform implementation effectiveness' to understand the evaluation of colorectal cancer patients on this mobile healthcare platform."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metaverse multi-dimensional rehabilitation platform'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform.', 'detailedDescription': 'The investigatorse intend to invite colorectal cancer survivors and their families to use the metaverse multi-dimensional rehabilitation platform. Interviews with users, user experience optimization of the metaverse multi-dimensional rehabilitation platform, and then evaluation of the platform through system usability evaluation. Gain insight into the experience of colorectal cancer survivors using the metaverse multi-dimensional rehabilitation platform, and understand their opinions and suggestions to explore the usability of the metaverse multi-dimensional rehabilitation platform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing adjuvant therapy after radical colorectal cancer resection; Age over 18 years old, under 65 years old, non-pregnant; Volunteering to participate in the research of this topic; Mobile phones are available\n\nExclusion Criteria:\n\n* Patients with multiple cancers; Have special dietary needs.'}, 'identificationModule': {'nctId': 'NCT06354595', 'briefTitle': 'Feasibility Study of Multidimensional Rehabilitation in the Metaverse', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'Feasibility Study of Multidimensional Rehabilitation in the Metaverse', 'orgStudyIdInfo': {'id': 'XiamenU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Colorectal cancer survivors and their families', 'description': 'Using the Colorectal Cancer Survivor Metaverse Multidimensional Rehabilitation Platform, and provide feedback and suggestions.', 'interventionNames': ['Device: Multidimensional Rehabilitation in the Metaverse']}], 'interventions': [{'name': 'Multidimensional Rehabilitation in the Metaverse', 'type': 'DEVICE', 'description': 'Using the multidimensional rehabilitation space in the metaverse, evaluate the platform after use.', 'armGroupLabels': ['Colorectal cancer survivors and their families']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361005', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuru HU', 'role': 'CONTACT', 'email': '15903017593@163.com', 'phone': '18189530895'}], 'facility': 'Yuru Hu', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Qu SHEN', 'role': 'CONTACT', 'email': 'shenqumail@163.com', 'phone': '+865922189613'}], 'overallOfficials': [{'name': 'Yuru HU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiamen University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qu Shen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Qu Shen', 'investigatorAffiliation': 'Xiamen University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-09', 'type': 'RELEASE'}, {'date': '2024-10-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Qu Shen, Associate Professor, Xiamen University'}}}}