Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Completed

Conditions: Febrile Neutropenia
Chemotherapy-induced Neutropenia
Pediatric Cancer
Oncology

Interventions: Device: Everion

Registration Number: NCT04134429

Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Everion®	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)	14 days	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).

Secondary Outcome Measures

Name	Time	Method
Continous Monitoring of Heart Rate Variability With the WD	14 days	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).
Continous Monitoring of Perfusion Index With the WD	14 days	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).
Cumulative Time of Monitoring Heart Rate With the WD	14 days	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).
Number and Description of Side Effects	14 days	Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.
Continous Monitoring of Oxygen Saturation With the WD	14 days	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).
Effort for Investigators Assessed by Duration of Contacts	14 days	Effort (cumulative duration of contacts) for the Investigators.
Continous Monitoring of Respiration Rate With the WD	14 days	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).
Comparison	14 days	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.
Continous Monitoring of Core Temperature With the WD	14 days	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).
Cumulative Time of Monitoring Oxygen Saturation With the WD	14 days	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).
Cumulative Time of Monitoring Respiration Rate With the WD	14 days	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).
Cumulative Time of Monitoring Core Temperature With the WD	14 days	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).
Cumulative Time of Monitoring Heart Rate Variability With the WD	14 days	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).
Cumulative Time of Monitoring Perfusion Index With the WD	14 days	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).
Device Acceptance Assessed With Questionnaires	14 days	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.
Effort for Investigators Assessed by Number of Contacts	14 days	Effort (cumulative number of contacts) for the Investigators.
Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection	14 days	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.