About this trial
The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities.
The main questions it aims to answer are:
* Will participants adhere to the telemonitoring system? * Is the intervention feasible, in terms of the device's failure to record temperature data? * Will parents behave appropriately when using the device? * How satisfied will parents and caregivers be? * What will be the physical tolerance of the device? * On an exploratory basis, will the remote monitoring system be effective for months?
Researchers will compare :
* patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device * with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 0 to 17 inclusive
Followed in the Pediatric Onco-Hematology Department
Primo-diagnosed with solid or hematological cancer (incident case)
Having received a first cycle of chemotherapy
Disqualifiers
with a dermatosis contraindicating the use of the device
Refusing to participate in the study
Trial design
Parallel
Treatments tested in this trial
Remote temperature monitoring device
Device* Use of the Tucky® remote monitoring device for continuous temperature monitoring at home, * In combination with education sessions on temperature monitoring and the device.
Home temperature monitoring by a nurse
Diagnostic test* Home temperature monitoring by a nyrse, twice a day, * In association with education sessions on temperature monitoring.
Treatment groups
Trial outcomes
Primary outcomes
study acceptability rate
number of patients included/number of eligible patients offered the study.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: