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Идёт набор NCT05505188

Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer

Без фазы С лечением Neuropathic Pain Anxiety Disorder/Anxiety State Pain, Chronic Alcohol Use Disorder

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: Questionnaire.
Кому может быть актуально
Состояния в реестре: Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder. Базовые параметры: от 18 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

Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer

Обзор

Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week. The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life. The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment. This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months. The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.

Вмешательства

  • Другое Questionnaire
    Self-questionnaires are completed by the patient at the time of this consultation: * Neuropathic pain: NPSI in screening * Anxiety/depression: HADS in screening * Quality of life: EORTC (QLQC30 and H\&N43) * Fatigue: MFI-20 hese self-questionnaires will be retrieved by the Clinical Research Associate (CRA) for verification. Depending on the result of the NPSI questionnaire can be completed to better characterize neuropathic pain. Depending on the result of the HADS, the MADRS questionnaire ca

Первичные конечные точки

  • change, neuropathic pain 1 [Срок оценки: Day 0", "Month 6"]
Вторичные конечные точки (11)
  • change, anxiety/depression [Срок оценки: Day 0", "Month 6"]
  • change, anxiety/depression 1 [Срок оценки: Day 0", "Month 6"]
  • change, quality of life [Срок оценки: Day 0", "Month 6"]
  • change, quality of life 1 [Срок оценки: Day 0", "Month 6"]
  • change, fatigue [Срок оценки: Day 0", "Month 6"]
  • change, symptoms related to head and neck cancer [Срок оценки: Day 0", "Month 6"]
  • change, sleep [Срок оценки: Day 0", "Month 6"]
  • change, the impact of pain [Срок оценки: Day 0", "Month 6"]
  • change, Alcohol Use and Consumption Disorder [Срок оценки: Day 0", "Month 6"]
  • change use of other psychoactive substances [Срок оценки: Day 0", "Month 6"]
  • change severity of nicotine addiction [Срок оценки: Day 0", "Month 6"]

Критерии участия

Критерии включения

  • Patients with a first Head and neck cancer whose therapeutic sequence involves radiotherapy
  • Patient over 18 years of age
  • Having given written consent
  • patient not previously treated with radiotherapy
  • Life expectancy > 3 months
  • World Health Organization (WHO) score < 3
  • Histologically proven Head and Neck cancer
  • Stable patient, with no signs of recurrence or other progressive neoplasia at the time of the examination
  • Patient treated with radiotherapy
  • Patient fluent in French

Критерии исключения

  • Non-consenting patient
  • History of malignancy, other than treated and cured basal cell or cervical cancer
  • Patient who has had a salvage surgery other than lymph node removal
  • Patient with evidence of recurrence or other progressive neoplasia at the time of examination
  • Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
  • Uncontrolled infectious pathology
  • Patient under 18 years of age
  • Patient who is not fluent in French
  • Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Caen University Hospital — Caen

Идентификаторы

NCT: NCT05505188 · 2020-A01894-35

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗