Pediatric CancerNCT04914702
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
An observational study of Pediatric Cancer and Febrile Neutropenia, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied. Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pediatric Cancer, Febrile Neutropenia, Oncology
- What is being tested?
- Everion® and CORE®
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 16 Sep 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 undergoing chemotherapy for cancer treated in the departments of pediatric oncology at the Children's university hosptials Bern or Basel.
Who may be able to join
- Chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation.
- Age from 1 month to 17.99 years at time of recruitment
- Written informed consent from parents and participants, where applicable
Who cannot join
- Local skin diseases prohibiting wearing of the WD.
- Denied written informed consent from participants
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Basel, University of Basel
Basel
Inselspital
Bern, 3010
About this study
Official title: Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study
In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.
Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.
Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.
Read the detailed description
In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.
In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.
Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.
- Being tested
- Everion®, CORE®
- Keywords
- Wearable device, Everion®, CORE®, Continuous recording, Vital signs, Pediatric oncology
- Medical subject headings
- Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everion®Device
The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
CORE®Device
The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Everion® only | Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. Receives: Device: Everion® | |
| CORE® only | A CORE® device 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: CORE® | |
| Everion® first, CORE® second | Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
Then a CORE® device 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®; Device: CORE® | |
| CORE® first, Everion® second | A CORE® device 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.
Then two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. Receives: Device: Everion®; Device: CORE® | |
| Everion® and CORE® simultaneously | Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, and one CORE® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. Receives: Device: Everion®; Device: CORE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of continous recording of core temperature with the two wearable devices (WDs)
The primary outcome is defined as at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) of core temperature measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Measured: 14 days
Secondary outcomes (17)
Feasibility of continous recording of heart rate with the Everion®
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Measured: 14 days
Feasibility of continous recording of heart rate variability with the Everion®
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate variability measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Measured: 14 days
Feasibility of continous recording of respiration rate with the Everion®
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of respiration rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Measured: 14 days
Cumulative time of monitoring core temperature with the two wearable devices (WDs)
Cumulative length of time with recorded core temperature with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) per study day.
Measured: 14 days
Cumulative time of monitoring heart rate with the Everion®
Cumulative length of time with recorded heart rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Measured: 14 days
Cumulative time of monitoring heart rate variability with the Everion®
Cumulative length of time with recorded heart rate variability with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Measured: 14 days
Cumulative time of monitoring respiration rate with the Everion®
Cumulative length of time with recorded respiration rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Measured: 14 days
Data arrival on the dashboard for core temperature (Everion®)
Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the Everion®
Measured: 14 days
Data arrival on the dashboard for core temperature (CORE®)
Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the CORE®
Measured: 14 days
Effort for investigators assessed by number of contacts
Cumulative number of contacts with the participants for the Investigators.
Measured: 14 days
Effort for investigators assessed by duration of contacts
Cumulative duration of contacts with the participants for the Investigators.
Measured: 14 days
Acceptability of Everion®
Proportion of participants indicating that continuous monitoring with the Everion® is acceptable (binary outcome, measured once).
Measured: 14 days
Acceptability of CORE®
Proportion of participants indicating that continuous monitoring with the CORE® is acceptable (binary outcome, measured once).
Measured: 14 days
Side Effects
Number and description of side effects reported by participants, if applicable (categorical outcome) and comparison of the side-effects of the two different WDs.
Measured: 14 days
User-friendliness
Comparison of the user-friendliness and preference of the different WDs as judged by the participants (categorical outcome, assessed with questionnaires)
Measured: 14 days
Comparison of core temperature with discrete measurements
Difference between discrete measurements of core temperature, performed by the participants, if applicable, twice daily or more if clinically indicated and the measured signal from both WDs at the corresponding time.
Measured: 14 days
Exploration
Exploration of potential changes in or specific patterns of all measured signals within 48 hours before clinical diagnosis of fever, with or without neutropenia, 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 posted7 Jun 2021
- Study start16 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT04914702
- Sponsor's protocol ID
- Bern/Basel 2021 WD Pilot
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- 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, Schneider C, Wyss J, Roessler J, Brack E. Continuous timely monitoring of core temperature with two wearable devices in pediatric patients undergoing chemotherapy for cancer - a comparison study. Support Care Cancer. 2024 Feb 24;32(3):188. doi: 10.1007/s00520-024-08366-w.
PubMed 38400942
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04914702
- Acronym / sponsor ID
- Bern/Basel 2021 WD Pilot
- Keywords
- Wearable device, Everion®, CORE®, Continuous recording, Vital signs, 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
- 16 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
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 continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.
Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.
Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.
Detailed description
In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.
In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.
Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Everion® only | – | Device: Everion®Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. |
| CORE® only | – | Device: CORE®A CORE® device 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® first, CORE® second | – | Device: Everion®, Device: CORE®Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. Then a CORE® device 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. |
| CORE® first, Everion® second | – | Device: Everion®, Device: CORE®A CORE® device 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. Then two Everion® devices, one for the day and one for the night, to be switched every morning and evening, will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. |
| Everion® and CORE® simultaneously | – | Device: Everion®, Device: CORE®Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, and one CORE® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for 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 undergoing chemotherapy for cancer treated in the departments of pediatric oncology at the Children's university hosptials Bern or Basel.
Key inclusion criteria (3 listed)
- Chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation.
- Age from 1 month to 17.99 years at time of recruitment
- Written informed consent from parents and participants, where applicable
Key exclusion criteria (2 listed)
- Local skin diseases prohibiting wearing of the WD.
- Denied written informed consent from participants
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 |
|---|---|---|
| Everion®The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. | Device | CORE® first, Everion® second, Everion® and CORE® simultaneously, Everion® first, CORE® second, Everion® only |
| CORE®The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene. | Device | CORE® first, Everion® second, CORE® only, Everion® and CORE® simultaneously, Everion® first, CORE® second |
Primary outcome
Feasibility of continous recording of core temperature with the two wearable devices (WDs)
Time frame: 14 days
The primary outcome is defined as at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) of core temperature measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
17 secondary outcomes
Feasibility of continous recording of heart rate with the Everion®
Time frame: 14 days
Feasibility of continous recording of heart rate variability with the Everion®
Time frame: 14 days
Feasibility of continous recording of respiration rate with the Everion®
Time frame: 14 days
Cumulative time of monitoring core temperature with the two wearable devices (WDs)
Time frame: 14 days
Cumulative time of monitoring heart rate with the Everion®
Time frame: 14 days
Cumulative time of monitoring heart rate variability with the Everion®
Time frame: 14 days
Cumulative time of monitoring respiration rate with the Everion®
Time frame: 14 days
Data arrival on the dashboard for core temperature (Everion®)
Time frame: 14 days
Data arrival on the dashboard for core temperature (CORE®)
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
Acceptability of Everion®
Time frame: 14 days
Acceptability of CORE®
Time frame: 14 days
Side Effects
Time frame: 14 days
User-friendliness
Time frame: 14 days
Comparison of core temperature with discrete measurements
Time frame: 14 days
Exploration
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 38400942Koenig C, Ammann RA, Schneider C, Wyss J, Roessler J, Brack E. Continuous timely monitoring of core temperature with two wearable devices in pediatric patients undergoing chemotherapy for cancer - a comparison study. Support Care Cancer. 2024 Feb 24;32(3):188. doi: 10.1007/s00520-024-08366-w.
- 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
2 sites 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 2 sites 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 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 recording of core temperature with the two wearable devices (WDs) (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 NCT04914702, 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 11 Jul 2022.