In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from \>50% in certain high risk situations to \<1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment. Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications. This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.
Primary objective The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. Secondary objectives Regarding safety A. Number of fever episodes (FE) with safety relevant events (SREs) B. Number of false alerts C. Number of missed alarms Regarding efficacy D. Delay of chemotherapy application E. Duration of antimicrobial application except i.v. antibiotics F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL G. FEs according to chemotherapy intensity H. WD measured core temperature at time of fever detection by ear thermometer I. FEs reported outside TARs J. Quality of life Questionnaire K. Assessment of the side-effects of the WD Tertiary objective L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature M. Pattern search using data mining
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
250
Fever alerts are automated sent to participants if fever is detected
Childrens' Clinc Bern, Inselspital Bern
Bern, Switzerland
The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer.
The cumulative duration of i.v. antibiotics applied
Time frame: 3 to 9 month per patient
Number of fever episodes (FE) with safety relevant events (SREs)
Number of FE with SREs
Time frame: 3 to 9 month per patient
Number of false alerts
Number of false alerts
Time frame: 3 to 9 month per patient
Number of missed alarms
Number of missed alarms
Time frame: 3 to 9 month per patient
Delay of chemotherapy application
Duration of delay of chemotherapy application in days
Time frame: 3 to 9 month per patient
Duration of antimicrobial application except i.v. antibiotics
Duration of antimicrobial application except i.v. antibiotics
Time frame: 3 to 9 month per patient
Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL
Number of FEs diagnosed below or at TL versus above TL
Time frame: 3 to 9 month per patient
FEs according to chemotherapy intensity
Amount of fever episodes according to chemotherapy intensity
Time frame: 3 to 9 month per patient
Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer
WD measured core temperature at time of fever detection by ear thermometer
Time frame: 3 to 9 month per patient
FEs reported outside times of risk (TARs)
Amount of fever episodes reported outside TARs
Time frame: 3 to 9 month per patient
Quality of life Questionnaire
Proportion of participants indicating that wearing a WDs is acceptable/unacceptable, not increasing anxiety/increasing anxiety, providing/not providing security, increase burden/effort or not
Time frame: Month 1, 6 and at study completion, an average of 1 year
Assessment of the side-effects of the WD
Side effects reported by participants, if applicable
Time frame: Through study completion, an average of 1 year
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