Clinical trial NCT04914702: Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Official title: Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Febrile Neutropenia
Oncology
Chemotherapy-induced Neutropenia
Keywords: Wearable device
Everion®
CORE®
Continuous recording
Vital signs
Pediatric oncology
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-06-07
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 undergoing chemotherapy for cancer treated in the departments of pediatric oncology at the Children's university hosptials Bern or Basel.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of continous recording of core temperature with the two wearable devices (WDs)
timeFrame: 14 days
Secondary outcomes:
measure: Feasibility of continous recording of heart rate with the Everion®
timeFrame: 14 days
measure: Feasibility of continous recording of heart rate variability with the Everion®
timeFrame: 14 days
measure: Feasibility of continous recording of respiration rate with the Everion®
timeFrame: 14 days
measure: Cumulative time of monitoring core temperature with the two wearable devices (WDs)
timeFrame: 14 days
measure: Cumulative time of monitoring heart rate with the Everion®
timeFrame: 14 days
measure: Cumulative time of monitoring heart rate variability with the Everion®
timeFrame: 14 days
measure: Cumulative time of monitoring respiration rate with the Everion®
timeFrame: 14 days
measure: Data arrival on the dashboard for core temperature (Everion®)
timeFrame: 14 days
measure: Data arrival on the dashboard for core temperature (CORE®)
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: Acceptability of Everion®
timeFrame: 14 days
measure: Acceptability of CORE®
timeFrame: 14 days
measure: Side Effects
timeFrame: 14 days
measure: User-friendliness
timeFrame: 14 days
measure: Comparison of core temperature with discrete measurements
timeFrame: 14 days
measure: Exploration
timeFrame: 14 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel, University of Basel
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: