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Идёт набор NCT03435042

A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.

Без фазы С лечением Pediatric Cancer

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: Self care + Hypnosis group.
Кому может быть актуально
Состояния в реестре: Pediatric Cancer. Базовые параметры: от 8 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
Бельгия
Следующий шаг
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Обзор

Background: A lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. Their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. Different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. However, more research is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. It has been used efficiently to improve the well-being of adults with cancer. This paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents. Methods: Our pilot study showed that our intervention was feasible and positive for the participants. To test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. Data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview. Discussion: There is a growing interest in hypnosis in oncology settings. The results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.

Вмешательства

  • Поведенческое Self care + Hypnosis group
    Our groupal intervention is divided into 6 monthly 2-hour sessions in which some self-hypnosis exercises are proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.

Первичные конечные точки

  • Change in children's quality of life [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' conception of their child's quality of life [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in children's cancer-related fatigue [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' fatigue [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
Вторичные конечные точки (3)
  • Change in the family impact of the cancer [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' emotional distress [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]
  • Change in parents' coping strategies [Срок оценки: T0 (before the intervention), T1 (right after the intervention : 6 months later)]

Критерии участия

Критерии включения

  • Children and their siblings:
  • To be 8 to 18 year-old
  • To suffer from cancer (all localisations, stage and treatments accepted) or to have a sibling who suffer from cancer
  • To speak french
  • Parents:
  • To have a child who suffer from cancer
  • To speak french

Критерии исключения

  • /

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Бельгия · 1 центр
  • University Hospital of Liege — Liège

Публикации

  • Gregoire C, Chantrain C, Faymonville ME, Marini J, Bragard I. A HYPNOSIS-BASED GROUP INTERVENTION TO IMPROVE QUALITY OF LIFE IN CHILDREN WITH CANCER AND THEIR PARENTS. Int J Clin Exp Hypn. 2019 Apr-Jun;67(2):117-135. doi: 10.1080/00207144.2019.1580965. PMID 30939086

Идентификаторы

NCT: NCT03435042 · Hypnose enfant cancer

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗