Clinical trial NCT04134429: Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Official title: Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Febrile Neutropenia
Chemotherapy-induced Neutropenia
Oncology
Keywords: wearable device
Everion®
Fever and Neutropenia
Pediatric Oncology
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients under chemotherapy for any malignancy

Brief summary: In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

Detailed description: No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.

Eligibility criteria: Inclusion Criteria:

* Chemotherapy treatment because of any malignancy, expected to last ≥1 months at time of recruitment for myelosuppressive therapy or at least one cycle of myeloablative therapy.
* Age 1 month to \<18 years at time of recruitment
* Written informed consent from patients and/or parents

Exclusion Criteria:

* Local skin diseases prohibiting wearing of the device.
* Denied written informed consent from patients and/or parent

Primary outcomes:
measure: Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
timeFrame: 14 days
Secondary outcomes:
measure: Continous Monitoring of Oxygen Saturation With the WD
timeFrame: 14 days
measure: Continous Monitoring of Respiration Rate With the WD
timeFrame: 14 days
measure: Continous Monitoring of Core Temperature With the WD
timeFrame: 14 days
measure: Continous Monitoring of Heart Rate Variability With the WD
timeFrame: 14 days
measure: Continous Monitoring of Perfusion Index With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Heart Rate With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Oxygen Saturation With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Respiration Rate With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Core Temperature With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Heart Rate Variability With the WD
timeFrame: 14 days
measure: Cumulative Time of Monitoring Perfusion Index With the WD
timeFrame: 14 days
measure: Device Acceptance Assessed With Questionnaires
timeFrame: 14 days
measure: Number and Description of Side Effects
timeFrame: 14 days
measure: Effort for Investigators Assessed by Number of Contacts
timeFrame: 14 days
measure: Effort for Investigators Assessed by Duration of Contacts
timeFrame: 14 days
measure: Comparison
timeFrame: 14 days
measure: Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection
timeFrame: 14 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
name: Eva Brack, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
name: Christa Koenig, MD
role: STUDY_CHAIR
References:
citation: Koenig C, Ammann RA, Kuehni CE, Roessler J, Brack E. Continuous recording of vital signs with a wearable device in pediatric patients undergoing chemotherapy for cancer-an operational feasibility study. Support Care Cancer. 2021 Sep;29(9):5283-5292. doi: 10.1007/s00520-021-06099-8. Epub 2021 Mar 3.