Clinical trial · Observational
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Everion®
- description
- 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.
- interventionNames
- Device: Everion
Primary outcomes (1)
- measure
- Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
- timeFrame
- 14 days
- description
- 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 outcomes (17)
- measure
- Continous Monitoring of Oxygen Saturation With the WD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKoenig 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. PMID 33655413