Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Chemotherapy-induced Neutropenia; Febrile Neutropenia; Oncology; Pediatric Cancer

Treatments: Device: Everion

Study type: Observational

Funder types: Other

Identifiers

NCT04134429

Bern 2019 WD Pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Everion®

Description:

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.

Treatment:

Device: Everion