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

NCT06697262 | Not Yet Recruiting

• 1 other identifier: 2024/CHU/03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• study acceptability rate

  number of patients included/number of eligible patients offered the study.

  24 months

Study Arms (2)

remote temperature monitoring device

EXPERIMENTAL

Device: Remote temperature monitoring device

home temperature monitoring by a nurse

ACTIVE COMPARATOR

Diagnostic Test: Home temperature monitoring by a nurse

Interventions

Home temperature monitoring by a nurse DIAGNOSTIC_TEST

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

home temperature monitoring by a nurse

Remote temperature monitoring device 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.

remote temperature monitoring device

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patient:
• with a dermatosis contraindicating the use of the device
• Refusing to participate in the study

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Véronique ARMAND

CONTACT

+262 2 62 90 61 10; ide.coord.oncoped.fguyon@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 4, 2028
• Study Completion (Estimated): May 4, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share