Набор скоро начнётся NCT06697262

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

Без фазы С лечением Oncopediatrics Febrile Neutropenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Remote temperature monitoring device, Home temperature monitoring by a nurse.
Кому может быть актуально: Состояния в реестре: Oncopediatrics, Febrile Neutropenia. Базовые параметры: 0 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Список центров уточняется — проверьте первичный протокол.
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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)

Вмешательства

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

Первичные конечные точки

study acceptability rate [Срок оценки: 24 months]

Критерии участия

Критерии включения

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.