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

Not Applicable

Not yet recruiting

• Conditions: Oncopediatrics; Febrile Neutropenia

• Registration Number: NCT06697262
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-02-01
• Primary Completion: 2027-02-04
• Study Completion: 2027-02-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
study acceptability rate	24 months	number of patients included/number of eligible patients offered the study.