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

NCT ID: NCT06697262

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2028-05-04

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)

Conditions

Oncopediatrics; Febrile Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

remote temperature monitoring device

Group Type: EXPERIMENTAL

Remote temperature monitoring device

Intervention Type: 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.

home temperature monitoring by a nurse

Group Type: ACTIVE_COMPARATOR

Home temperature monitoring by a nurse

Intervention Type: DIAGNOSTIC_TEST

• Home temperature monitoring by a nyrse, twice a day,
• In association with education sessions on temperature monitoring.

Interventions

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.

Intervention Type: DEVICE

Home temperature monitoring by a nurse

• Home temperature monitoring by a nyrse, twice a day,
• In association with education sessions on temperature monitoring.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Véronique ARMAND

Role: CONTACT

ide.coord.oncoped.fguyon@chu-reunion.fr

+262 2 62 90 61 10

Other Identifiers

2024/CHU/03

Identifier Type: -

Identifier Source: org_study_id