Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorCentre Hospitalier Universitaire de la Réunion

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 volunteers

Qualifiers

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

Design model

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

30 Participants
are divided into 2 treatment groups
Group A: remote temperature monitoring deviceExperimental treatment 1 intervention
Group B: home temperature monitoring by a nurseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

study acceptability rate

number of patients included/number of eligible patients offered the study.

Time frame
24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: