Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

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).

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).

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).

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).

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).

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 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 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 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 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).

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).

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).

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 reported by parents and patients, if applicable. Assessed with questionnaires.

Effort (cumulative number of contacts) for the Investigators.

Effort (cumulative duration of contacts) for the Investigators.

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 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.