Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04914702
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of continous recording of core temperature with the two wearable devices (WDs)', 'timeFrame': '14 days', 'description': 'The primary outcome is defined as at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) of core temperature measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of continous recording of heart rate with the Everion®', 'timeFrame': '14 days', 'description': 'At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.'}, {'measure': 'Feasibility of continous recording of heart rate variability with the Everion®', 'timeFrame': '14 days', 'description': 'At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate variability measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.'}, {'measure': 'Feasibility of continous recording of respiration rate with the Everion®', 'timeFrame': '14 days', 'description': 'At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of respiration rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.'}, {'measure': 'Cumulative time of monitoring core temperature with the two wearable devices (WDs)', 'timeFrame': '14 days', 'description': 'Cumulative length of time with recorded core temperature with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) per study day.'}, {'measure': 'Cumulative time of monitoring heart rate with the Everion®', 'timeFrame': '14 days', 'description': 'Cumulative length of time with recorded heart rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.'}, {'measure': 'Cumulative time of monitoring heart rate variability with the Everion®', 'timeFrame': '14 days', 'description': 'Cumulative length of time with recorded heart rate variability with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.'}, {'measure': 'Cumulative time of monitoring respiration rate with the Everion®', 'timeFrame': '14 days', 'description': 'Cumulative length of time with recorded respiration rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.'}, {'measure': 'Data arrival on the dashboard for core temperature (Everion®)', 'timeFrame': '14 days', 'description': 'Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the Everion®'}, {'measure': 'Data arrival on the dashboard for core temperature (CORE®)', 'timeFrame': '14 days', 'description': 'Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the CORE®'}, {'measure': 'Effort for investigators assessed by number of contacts', 'timeFrame': '14 days', 'description': 'Cumulative number of contacts with the participants for the Investigators.'}, {'measure': 'Effort for investigators assessed by duration of contacts', 'timeFrame': '14 days', 'description': 'Cumulative duration of contacts with the participants for the Investigators.'}, {'measure': 'Acceptability of Everion®', 'timeFrame': '14 days', 'description': 'Proportion of participants indicating that continuous monitoring with the Everion® is acceptable (binary outcome, measured once).'}, {'measure': 'Acceptability of CORE®', 'timeFrame': '14 days', 'description': 'Proportion of participants indicating that continuous monitoring with the CORE® is acceptable (binary outcome, measured once).'}, {'measure': 'Side Effects', 'timeFrame': '14 days', 'description': 'Number and description of side effects reported by participants, if applicable (categorical outcome) and comparison of the side-effects of the two different WDs.'}, {'measure': 'User-friendliness', 'timeFrame': '14 days', 'description': 'Comparison of the user-friendliness and preference of the different WDs as judged by the participants (categorical outcome, assessed with questionnaires)'}, {'measure': 'Comparison of core temperature with discrete measurements', 'timeFrame': '14 days', 'description': 'Difference between discrete measurements of core temperature, performed by the participants, if applicable, twice daily or more if clinically indicated and the measured signal from both WDs at the corresponding time.'}, {'measure': 'Exploration', 'timeFrame': '14 days', 'description': 'Exploration of potential changes in or specific patterns of all measured signals within 48 hours before clinical diagnosis of fever, with or without neutropenia, if applicable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable device', 'Everion®', 'CORE®', 'Continuous recording', 'Vital signs', 'Pediatric oncology'], 'conditions': ['Pediatric Cancer', 'Febrile Neutropenia', 'Oncology', 'Chemotherapy-induced Neutropenia']}, 'referencesModule': {'references': [{'pmid': '38400942', 'type': 'DERIVED', 'citation': 'Koenig C, Ammann RA, Schneider C, Wyss J, Roessler J, Brack E. Continuous timely monitoring of core temperature with two wearable devices in pediatric patients undergoing chemotherapy for cancer - a comparison study. Support Care Cancer. 2024 Feb 24;32(3):188. doi: 10.1007/s00520-024-08366-w.'}]}, 'descriptionModule': {'briefSummary': 'In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.\n\nVital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.\n\nResults from the two different WDs will be compared. Study duration for each participant is 14 days per device.', 'detailedDescription': 'In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.\n\nIn this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.\n\nSecond, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients undergoing chemotherapy for cancer treated in the departments of pediatric oncology at the Children's university hosptials Bern or Basel.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation.\n* Age from 1 month to 17.99 years at time of recruitment\n* Written informed consent from parents and participants, where applicable\n\nExclusion Criteria:\n\n* Local skin diseases prohibiting wearing of the WD.\n* Denied written informed consent from participants'}, 'identificationModule': {'nctId': 'NCT04914702', 'briefTitle': 'Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study', 'orgStudyIdInfo': {'id': 'Bern/Basel 2021 WD Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Everion® only', 'description': "Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.", 'interventionNames': ['Device: Everion®']}, {'label': 'CORE® only', 'description': "A CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.", 'interventionNames': ['Device: CORE®']}, {'label': 'Everion® first, CORE® second', 'description': "Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.\n\nThen a CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.", 'interventionNames': ['Device: Everion®', 'Device: CORE®']}, {'label': 'CORE® first, Everion® second', 'description': "A CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.\n\nThen two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.", 'interventionNames': ['Device: Everion®', 'Device: CORE®']}, {'label': 'Everion® and CORE® simultaneously', 'description': "Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, and one CORE® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.", 'interventionNames': ['Device: Everion®', 'Device: CORE®']}], 'interventions': [{'name': 'Everion®', 'type': 'DEVICE', 'description': "The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.", 'armGroupLabels': ['CORE® first, Everion® second', 'Everion® and CORE® simultaneously', 'Everion® first, CORE® second', 'Everion® only']}, {'name': 'CORE®', 'type': 'DEVICE', 'description': "The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.", 'armGroupLabels': ['CORE® first, Everion® second', 'CORE® only', 'Everion® and CORE® simultaneously', 'Everion® first, CORE® second']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': "University Children's Hospital Basel, University of Basel", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Eva Brack, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Hematology/Oncology, Inselspital, Bern University Hospital'}, {'name': 'Christa Koenig, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pediatric Hematology/Oncology, Inselspital, Bern University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of the study results, no time limitation after publication.', 'ipdSharing': 'YES', 'description': 'The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.', 'accessCriteria': 'Open Access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}