Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

NCT04134429 | Completed Results

• 1 other identifier: Bern 2019 WD Pilot
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

wearable device; Everion®; Fever and Neutropenia; Pediatric Oncology

Outcome Measures

Primary Outcomes (1)

• Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)

  The primary outcome is defined as at least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

  14 days

Secondary Outcomes (17)

• Continous Monitoring of Oxygen Saturation With the WD

  14 days

• Continous Monitoring of Respiration Rate With the WD

  14 days

• Continous Monitoring of Core Temperature With the WD

  14 days

• Continous Monitoring of Heart Rate Variability With the WD

  14 days

• Continous Monitoring of Perfusion Index With the WD

  14 days

Study Arms (1)

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.

Device: Everion

Interventions

Everion DEVICE

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

Everion®

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients under chemotherapy for any malignancy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33655413 RESULT

MeSH Terms

Conditions

Neoplasms; Febrile Neutropenia; Fever; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

(i) The WDs were studied for only 14 days and compliance might be different during long-term use. (ii) The small number of patients precluded an analysis of patient factors (iii) The planned comparison of discrete measurements versus continuously was not feasible because the exact second-wise time point of discrete measurements was not available.

Results Point of Contact

• Title: Dr. med. Christa König
• Organization: insel Gruppe AG

christa.koenig@insel.ch

+41 31 632 21 11

Study Officials

• Eva Brack, MD-PhD

  Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Christa Koenig, MD

  Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: October 22, 2019
• Study Start: November 29, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the study results.
• Access Criteria: Open access

Locations

CH (1)