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Идёт набор NCT07117058

Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.

— Наблюдательное Generalized Anxiety Introspective & Anxiety-Prone Patient Depression, Anxiety Survivors of Childhood 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: New rapid screening tool for anxiety and depressive disorders, SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised), HADS (Hospital Anxiety and Depression Scale).
Кому может быть актуально
Состояния в реестре: Generalized Anxiety, Introspective & Anxiety-Prone Patient, Depression, Anxiety, Survivors of Childhood Cancer. Базовые параметры: 7 лет — 25 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

Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool

Обзор

In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.

Подробное описание

The aim of the HARMONY-Tool study is to develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children, adolescents and young adults cured of childhood cancer.

Вмешательства

  • Диагностический тест New rapid screening tool for anxiety and depressive disorders
    New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation
  • Диагностический тест SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
    Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.
  • Диагностический тест HADS (Hospital Anxiety and Depression Scale)
    Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old.

Первичные конечные точки

  • New rapid screening tool for anxiety-depressive disorders [Срок оценки: At inclusion]
  • SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) [Срок оценки: At inclusion]
  • HADS (Hospital Anxiety and Depression Scale) [Срок оценки: At inclusion]

Критерии участия

Критерии включения

  • Patients diagnosed with pediatric cancer before the age of 18,
  • Patient whose intensive treatment had ended at least 3 months prior to inclusion,
  • Patients considered to be in complete remission by the doctor responsible for their treatment,
  • Patient affiliated to or entitled under a social security scheme,
  • Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.

Критерии исключения

  • Refusal to participate expressed by the patient or minor,
  • Patients whose cancer has relapsed or progressed,
  • Pregnant women, women in labor, breast-feeding mothers,
  • Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,
  • Adults under legal protection (guardianship) or unable to express their consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 7 центров
  • CHU Angers — Angers
  • Centre Hospitalier Universitaire Caen Normandie — Caen
  • Centre Hospitalier Universitaire — Grenoble
  • IHOPe — Lyon
  • CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2 — Nice
  • Centre Hospitalier Universitaire — Rouen
  • CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07117058 · 23CH131 · 2024-A02404-43

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗