NCT06697262
Not Yet Recruiting
N/A
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
Centre Hospitalier Universitaire de la Réunion0 sites30 target enrollmentMay 1, 2026
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Oncopediatrics
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
- Enrollment
- 30
- Primary Endpoint
- study acceptability rate
- Status
- Not Yet Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •with a dermatosis contraindicating the use of the device
- •Refusing to participate in the study
Outcomes
Primary Outcomes
study acceptability rate
Time Frame: 24 months
number of patients included/number of eligible patients offered the study.
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