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Clinical Trials/NCT06697262
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)
Registry
clinicaltrials.gov
Start Date
May 1, 2026
End Date
May 4, 2028
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

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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