Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 7:32 PM
Study NCT ID:
NCT05235594
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in heart rate', 'timeFrame': '2 weeks', 'description': 'Changes in heart rate (beat per minute) will be presented descriptively.'}, {'measure': 'Changes in skin temperature', 'timeFrame': '2 weeks', 'description': 'Changes in skin temperature (°C) will be presented descriptively.'}, {'measure': 'Changes in physical activity', 'timeFrame': '2 weeks', 'description': 'Changes in physical activity (steps) will be presented descriptively.'}, {'measure': 'Changes in respirations frequency', 'timeFrame': '2 weeks', 'description': 'Changes in respirations frequency (respiration per minute) will be presented descriptively.'}, {'measure': 'Changes in thoracic impedance', 'timeFrame': '2 weeks', 'description': 'Changes in thoracic impedance (kOhm) will be presented descriptively.'}], 'primaryOutcomes': [{'measure': 'Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period', 'timeFrame': '2 weeks', 'description': 'To assess the feasibility of using the ChronolifeTM smart t-shirt based on the completion rate which is defined as the number of included patients using the smart t-shirt at least 12 hours pr. day during the three weeks study period.'}], 'secondaryOutcomes': [{'measure': 'Technical feasibility', 'timeFrame': '2 weeks', 'description': 'To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient reported outcomes', 'Smart t-shirt', 'Wearable', 'Patient-generated health data', 'Biometric sensor technology', 'Cancer'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '36190744', 'type': 'DERIVED', 'citation': 'Steen-Olsen EB, Pappot H, Green A, Langberg H, Hollander-Mieritz C. Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study. JMIR Res Protoc. 2022 Oct 3;11(10):e37626. doi: 10.2196/37626.'}]}, 'descriptionModule': {'briefSummary': "The study will assess the feasibility of using the ChronolifeTM smart t-shirt for home monitoring of vital parameters in cancer patients during their treatment course. This study will bring new insights to how wearables and biometric data can be used as a part of symptom recognition in cancer patients during treatment course in the quest of increasing patients' quality of life.", 'detailedDescription': "Collecting biometric sensor data by wearables is an example of real-time patient-generated health data that can provide vital and detailed objective information about patients. This may have the potential to improve quality of oncological treatment and increase patients' quality of life.\n\nStudies have shown that there may be a dissimilar perception on symptoms and side effects between patients and health care professionals. Wearables may help identifying symptoms earlier.\n\nA new design of a wearable is a smart t-shirt. A smart t-shirt has sensors embedded in the fabric which generate measurement flows. This new tool provide more precise information without recall and reporting bias which may have the potential to lead to a better and more accurate cancer treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish cancer patients ≥18 years in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark\n* Both patients in curative and palliative care will be eligible\n* 10 cancer patients under 39 years\n* 10 cancer patients over 65 years\n* Able to read and speak Danish\n\nExclusion Criteria:\n\n* Serious cognitive deficits'}, 'identificationModule': {'nctId': 'NCT05235594', 'briefTitle': 'Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study', 'orgStudyIdInfo': {'id': 'OncoSmartShirt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Smart shirt', 'description': 'The research intervention is, for all twenty patients, to wear a smart t-shirt connected to a smart phone throughout the day (preferably 8 hours pr day) for 2 weeks.', 'interventionNames': ['Device: Wearable sensor']}], 'interventions': [{'name': 'Wearable sensor', 'type': 'DEVICE', 'otherNames': ['ChronolifeTM Smart t-shirt', 'OncoSmartShirt'], 'description': 'The patients will be asked to wear a smart shirt. The shirt is designed with multiple sensors and electrodes fully embedded which engender 6 different measurement flows continuously. The smart t-shirt system is washable, and patients can wash and dry this t-shirt anytime, thus the shirt can be worn repeatedly.', 'armGroupLabels': ['Experimental: Smart shirt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3450', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Cecilie Holländer-Mieritz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Helle Pappot', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}