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NCT Number: NCT06697262

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

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)

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. study acceptability rate

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique ARMAND

CONTACT

[email protected]

+262 2 62 90 61 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: TELEDOM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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