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

Centre Hospitalier Universitaire de la Réunion

Status: Begins enrollment in 2 months

Conditions: Febrile Neutropenia; Oncopediatrics

Treatments: Device: Remote temperature monitoring device; Diagnostic Test: Home temperature monitoring by a nurse

Study type: Interventional

Funder types: Other

Identifiers

NCT06697262

2024/CHU/03

Details and patient eligibility

About

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)

Enrollment: 30 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

remote temperature monitoring device

Experimental group

Treatment:

Device: Remote temperature monitoring device

home temperature monitoring by a nurse

Active Comparator group

Treatment:

Diagnostic Test: Home temperature monitoring by a nurse