Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Febrile Neutropenia; Pediatric Cancer; Oncology; Chemotherapy-induced Neutropenia
• Intervention / Treatment: Device: Everion

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients under chemotherapy for any malignancy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continous Monitoring of Oxygen Saturation With the WD	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of oxygen saturation 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
Continous Monitoring of Respiration Rate With the WD	At least acceptable(≥50) quality score (worst quality 0, best quality 100) of respiration 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
Continous Monitoring of Core Temperature With the WD	At least acceptable(≥50) quality score (worst quality 0, best quality 100) of core temperature 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
Continous Monitoring of Heart Rate Variability With the WD	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate variability 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
Continous Monitoring of Perfusion Index With the WD	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of perfusion index 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
Cumulative Time of Monitoring Heart Rate With the WD	Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Cumulative Time of Monitoring Oxygen Saturation With the WD	Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Cumulative Time of Monitoring Respiration Rate With the WD	Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Cumulative Time of Monitoring Core Temperature With the WD	Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).	14 days
Cumulative Time of Monitoring Heart Rate Variability With the WD	Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Cumulative Time of Monitoring Perfusion Index With the WD	Cumulative length of time with monitored perfusion index with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Device Acceptance Assessed With Questionnaires	Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.	14 days
Number and Description of Side Effects	Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.	14 days
Effort for Investigators Assessed by Number of Contacts	Effort (cumulative number of contacts) for the Investigators.	14 days
Effort for Investigators Assessed by Duration of Contacts	Effort (cumulative duration of contacts) for the Investigators.	14 days
Comparison	Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.	14 days
Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection	Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of ≥39.0°C, or ≥38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.	14 days

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Eva Brack, MD-PhD, Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2019
• Primary Completion (ACTUAL): January 13, 2020
• Study Completion (ACTUAL): January 13, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric Oncology; wearable device; Everion®; Fever and Neutropenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: Bern 2019 WD Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.
• IPD Sharing Time Frame: After publication of the study results.
• IPD Sharing Access Criteria: Open access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No