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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06697262
Acronym
TELEDOM
Enrollment
30
Registered
2024-11-20
Start date
2026-05-01
Completion date
2028-05-04
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Oncopediatrics

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)

Interventions

DEVICERemote 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.

DIAGNOSTIC_TESTHome temperature monitoring by a nurse

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

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
study acceptability rate24 monthsnumber of patients included/number of eligible patients offered the study.

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026