Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT04613232
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': '3 months', 'description': 'Description of change in hear rate during radiotherapy'}, {'measure': 'Change in physical activity (steps per day)', 'timeFrame': '3 months', 'description': 'Description of change insteps per day during radiotherapy'}], 'primaryOutcomes': [{'measure': 'Number of participants who could wear the device more than 12 hours per day', 'timeFrame': '3 months', 'description': 'To determine the feasibility of using an Apple Watch to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Data acquisition rate', 'timeFrame': '3 months', 'description': 'Percentage of successful data acquisition events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartwatch', 'Radiotherapy'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '33983123', 'type': 'DERIVED', 'citation': 'Hollander-Mieritz C, Vogelius IR, Kristensen CA, Green A, Rindum JL, Pappot H. Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. JMIR Res Protoc. 2021 May 13;10(5):e26096. doi: 10.2196/26096.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.", 'detailedDescription': "Patients with head and neck cancer (HNC) experience severe side effects during radiotherapy (RT). Ongoing technological advances in wearable biometric sensors allow for real-time collection of objective data e.g. physical activity and heart rate, which in the future might help to detect and act against side effects before they become severe. A smartwatch such as the Apple Watch allows for objective data monitoring outside hospital with minimal effort for the patient. To find out if such tools can be implemented in the oncological setting feasibility studies are needed.\n\nThe aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.\n\nThe study will assess the feasibility of using the Apple Watch for home monitoring of patients with HNC. It will bring new insights to the patient's activity levels and how heart rate varies during treatment course. This is important knowledge before further investigating how biometric data can be used as part of symptom monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish patients ≥18 years planned to primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck at Rigshospitalet, University Hospital, Department of Oncology, Denmark.\n* Able to read and speak Danish\n\nExclusion Criteria:\n\n* Seious cognitive deficits'}, 'identificationModule': {'nctId': 'NCT04613232', 'acronym': 'OncoWatch', 'briefTitle': 'Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0', 'orgStudyIdInfo': {'id': 'OncoWatch 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apple Watch', 'description': 'The research intervention is continuously monitoring of heart rate and physical activity (minimum 12h/day) with a smartwatch which is connected to a smartphone.', 'interventionNames': ['Device: Wearable sensor']}], 'interventions': [{'name': 'Wearable sensor', 'type': 'DEVICE', 'otherNames': ['Smartwatch', 'Apple watch'], 'description': 'The patients will be asked to wear an Apple Watch during their treatment course. The watch will pasively collect sensor data (heart rate and physical activity)', 'armGroupLabels': ['Apple Watch']}]}, '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'}}}}