Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-29

Study Completion Date

2020-01-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Cancer Febrile Neutropenia Chemotherapy-induced Neutropenia Oncology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Everion®

The Everion® 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.

Everion

Intervention Type DEVICE

The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Interventions

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Everion

The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Intervention Type DEVICE

Eligibility Criteria

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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