Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote temperature monitoring device, Home temperature monitoring by a nurse.
- Who it may be relevant to
- Registry conditions: Oncopediatrics, Febrile Neutropenia. Basic parameters: 0 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of a Telemonitoring Device on the Occurrence of Fever at Home in Children at Risk of Chemotherapy-Induced Neutropenia: A Pilot Randomized Controlled Trial
Overview
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)
Interventions
- Device Remote temperature monitoring 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. - Diagnostic test Home temperature monitoring by a nurse
* Home temperature monitoring by a nyrse, twice a day, * In association with education sessions on temperature monitoring.
Primary outcome measures
- study acceptability rate [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
patient
- 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
- Whose family has psycho-social vulnerabilities assessed by the Froger et al. tool, indicating a need for an IDE to support the family in monitoring the patient.
Exclusion criteria
Patient:
- with a dermatosis contraindicating the use of the device
- Refusing to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06697262 · 2024/CHU/03