Chemotherapy-induced Neutropenia, Febrile Neutropenia, Oncology, Pediatric Cancer
Conditions
Keywords
wearable device, Everion®, Fever and Neutropenia, Pediatric Oncology
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.
Interventions
DEVICEEverion
The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| Number and Description of Side Effects | 14 days | Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires. |
| Effort for Investigators Assessed by Number of Contacts | 14 days | Effort (cumulative number of contacts) for the Investigators. |
| Effort for Investigators Assessed by Duration of Contacts | 14 days | Effort (cumulative duration of contacts) for the Investigators. |
| 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. |
| 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. |
| 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). |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Everion® | — |
|---|---|---|
| Age, Continuous | 6 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Switzerland | 20 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
| Type of malignancy Acute lymphoblastic leukemia | 12 Participants | — |
| Type of malignancy Central nervous system tumor | 3 Participants | — |
| Type of malignancy Other hematologic malignancies | 2 Participants | — |
| Type of malignancy Solid tumor | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD) | 6 Participants |
Secondary
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.
Time frame: 14 days
Population: The analysis of differences between discrete measurements and continuously recorded aggregates of vital signs, as defined in the protocol, was found to yield massively distorted results because rapidly changing discretely measured vital signs were compared to aggregated means covering up to 20 min. We deliberately refrain from displaying these nonmeaningful results here.
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Continous Monitoring of Core Temperature With the WD | 6 Participants |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Continous Monitoring of Heart Rate Variability With the WD | 1 Participants |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Continous Monitoring of Oxygen Saturation With the WD | 0 Participants |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Continous Monitoring of Perfusion Index With the WD | 6 Participants |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Continous Monitoring of Respiration Rate With the WD | 4 Participants |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Core Temperature With the WD | 4037 hours |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Heart Rate Variability With the WD | 3142 hours |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Heart Rate With the WD | 3992 hours |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Oxygen Saturation With the WD | 1103 hours |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Perfusion Index With the WD | 3992 hours |
Secondary
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).
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Everion® | Cumulative Time of Monitoring Respiration Rate With the WD | 4058 hours |
Secondary
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.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everion® | Device Acceptance Assessed With Questionnaires | 18 Participants |
Secondary
Effort for Investigators Assessed by Duration of Contacts
Effort (cumulative duration of contacts) for the Investigators.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everion® | Effort for Investigators Assessed by Duration of Contacts | 390 minutes |
Secondary
Effort for Investigators Assessed by Number of Contacts
Effort (cumulative number of contacts) for the Investigators.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everion® | Effort for Investigators Assessed by Number of Contacts | 52 Total number of contacts |
Secondary
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.
Time frame: 14 days
Population: The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode with fever or infection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Everion® | Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection | Episodes with fever | 3 Episodes |
| Everion® | Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection | Episodes with Infection | 1 Episodes |
Secondary
Number and Description of Side Effects
Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.
Time frame: 14 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everion® | Number and Description of Side Effects | itching | 3 Participants |
| Everion® | Number and Description of Side Effects | Superficial skin lesion | 1 Participants |
| Everion® | Number and Description of Side Effects | irritated skin | 4 Participants |
| Everion® | Number and Description of Side Effects | sweating | 7 Participants |