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Идёт набор NCT06455592

Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Без фазы С лечением Child, Only Blood Cancer Adapted Physical Activity Sleep

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: practice adapted physical activity, control arm.
Кому может быть актуально
Состояния в реестре: Child, Only, Blood Cancer, Adapted Physical Activity, Sleep. Базовые параметры: 5 лет — 16 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
Франция
Следующий шаг
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Официальное название

Effect of Practicing Adapted Physical Activity (APA) on Sleep Quality in Children From 5 Years of Age and Adolescents up to 16 Years of Age Undergoing Treatment for a Hematologic Malignancy.

Обзор

Main objective : Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16 Hypothesis : Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer

Подробное описание

Medical process are leading to an increase in the survival of children/adolescents undergoing treatment for blood cancer. Caregivers need to focus on optimizing these patients' quality of life during and after the disease. Sleep is essential to their development. Sleep disorders are symptoms reported by patients. They have a negative impact on their quality of life. Adapted physical activity sessions are offered in pediatric oncology departments, but sedentary behavior persists. The hypothesis is that the daily practice of adapted physical activity will improve sleep in patients treated for blood cancer.

This is a randomized, cross-over, open-label, two-armed parallel, unique center therapeutic trial comparing the effect of practice adapted physical activity only once during four days (conventional strategy) versus practice adapted physical activity each day during four days (experimental strategy) on the sleep of the children with blood cancer from 5 to 16 at the hospital in Clermont-Ferrand and at home.

The study will last four weeks with a wash-out week after 2 weeks. The outcomes are described later. The nurse informs and obtains the consent of the child and his parents. After statistical analysis of these two arms, it will be possible to determine the value of practice daily adapted physical activity on the sleep of children with blood cancer from 5 to 16 at the hospital and at home.

Вмешательства

  • Поведенческое practice adapted physical activity
    practice daily adapted physical activity during 4 days
  • Другое control arm
    practice once adapted physical activity during 4 days

Первичные конечные точки

  • Quality of sleep [Срок оценки: the morning and the evening, from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
Вторичные конечные точки (8)
  • Number of sleep's hour and night awakenings [Срок оценки: Each night from the bedtime to the wake up time, from the bedtime of the first day to the wake up time of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • rate of daily human physical activity in met/day [Срок оценки: from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • children quality of life [Срок оценки: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • chair stand-up test [Срок оценки: the morning of the first day and the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • vigilance status description [Срок оценки: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • children's pain self evaluation [Срок оценки: at 8am and 6pm from the first day to the third day and only at 8am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • fatigue status [Срок оценки: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
  • inflammation markers [Срок оценки: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]

Критерии участия

Критерии включения

  • Children from 5 to 16 with haematological cancer undergoing treatment
  • Subjects and their parents who were informed about the study and gave informed consent.
  • Enrollment in the Social Security system

Критерии исключения

  • Children on high-dose corticosteroids
  • Children under anxiolytic treatment
  • Children with sleep disorders (sleep apnea)
  • Children taking melatonin or sleeping pills
  • Contraindication to adapted physical activity
  • Refusal to participate on the part of the participant or his/her parents
  • Holders of parental authority under curatorship, guardianship, safeguard of justice
  • Pregnant or breast-feeding teenagers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06455592 · AOI 2022 LABRAISE · 2023-A02575-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗