Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Cancer, Febrile Neutropenia, Chemotherapy-induced Neutropenia, Oncology

Intervention / Treatment
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* Device: Everion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Everion®<br>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<br>* The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable device, Everion®, Fever and Neutropenia, Pediatric Oncology