Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.

Insel Gruppe AG, University Hospital Bern

Status: Completed

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

Treatments: Device: Everion®; Device: CORE®

Study type: Observational

Funder types: Other

Identifiers

NCT04914702

Bern/Basel 2021 WD Pilot

Details and patient eligibility

About

In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.

Vital 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.

Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.

Full description

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.

In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.

Second, 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.

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 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.
• Age from 1 month to 17.99 years at time of recruitment
• Written informed consent from parents and participants, where applicable

Exclusion criteria

• Local skin diseases prohibiting wearing of the WD.
• Denied written informed consent from participants

Trial design

20 participants in 5 patient groups

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.

Treatment:

Device: Everion®

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.

Treatment:

Device: CORE®

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. Then 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.

Treatment:

Device: CORE®

Device: Everion®

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. Then 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.

Treatment:

Device: CORE®

Device: Everion®

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.

Treatment:

Device: CORE®

Device: Everion®