Pediatric CancerNCT04134429
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
An observational study of Pediatric Cancer and Febrile Neutropenia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pediatric Cancer, Febrile Neutropenia, Chemotherapy-induced Neutropenia
- What is being tested?
- Everion
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Nov 2019to 13 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients under chemotherapy for any malignancy
Who may be able to join
- 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
Who cannot join
- Local skin diseases prohibiting wearing of the device.
- Denied written informed consent from patients and/or parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Everion
- Keywords
- wearable device, Everion®, Fever and Neutropenia, Pediatric Oncology
- Medical subject headings
- Neoplasms, Febrile Neutropenia, Fever, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverionDevice
The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Everion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days
Secondary outcomes (17)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 14 days
Number and Description of Side Effects
Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.
Measured: 14 days
Effort for Investigators Assessed by Number of Contacts
Effort (cumulative number of contacts) for the Investigators.
Measured: 14 days
Effort for Investigators Assessed by Duration of Contacts
Effort (cumulative duration of contacts) for the Investigators.
Measured: 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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start29 Nov 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Brack, MD-PhD, Principal investigator, Pediatric Hematology/Oncology, Inselspital, Bern University HospitalChrista Koenig, MD, Study chair, Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134429
- Sponsor's protocol ID
- Bern 2019 WD Pilot
- Status last verified
- May 2021
- First submitted
- 12 Sep 2019
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.
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.
PubMed 33655413
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04134429
- Acronym / sponsor ID
- Bern 2019 WD Pilot
- Keywords
- wearable device, Everion®, Fever and Neutropenia, Pediatric Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everion® | – | Device: EverionThe 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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients under chemotherapy for any malignancy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Local skin diseases prohibiting wearing of the device.
- Denied written informed consent from patients and/or parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverionThe Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. | Device | Everion® |
Primary outcome
Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
Time frame: 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).
17 secondary outcomes
Continous Monitoring of Oxygen Saturation With the WD
Time frame: 14 days
Continous Monitoring of Respiration Rate With the WD
Time frame: 14 days
Continous Monitoring of Core Temperature With the WD
Time frame: 14 days
Continous Monitoring of Heart Rate Variability With the WD
Time frame: 14 days
Continous Monitoring of Perfusion Index With the WD
Time frame: 14 days
Cumulative Time of Monitoring Heart Rate With the WD
Time frame: 14 days
Cumulative Time of Monitoring Oxygen Saturation With the WD
Time frame: 14 days
Cumulative Time of Monitoring Respiration Rate With the WD
Time frame: 14 days
Cumulative Time of Monitoring Core Temperature With the WD
Time frame: 14 days
Cumulative Time of Monitoring Heart Rate Variability With the WD
Time frame: 14 days
Cumulative Time of Monitoring Perfusion Index With the WD
Time frame: 14 days
Device Acceptance Assessed With Questionnaires
Time frame: 14 days
Number and Description of Side Effects
Time frame: 14 days
Effort for Investigators Assessed by Number of Contacts
Time frame: 14 days
Effort for Investigators Assessed by Duration of Contacts
Time frame: 14 days
Comparison
Time frame: 14 days
Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33655413Koenig 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.
- Individual participant dataSharing planned: Yes. The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Brack, MD-PhD principal investigator
Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
Christa Koenig, MD study chair
Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Febrile Neutropenia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.