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Идёт набор NCT06385132

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

— Наблюдательное Glioblastoma Head and Neck 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: Psychological Tests' administration.
Кому может быть актуально
Состояния в реестре: Glioblastoma, Head and Neck Cancer. Базовые параметры: 18 лет — 75 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
Италия
Следующий шаг
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Официальное название

GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients

Обзор

Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization. Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities. The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life. To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature. Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations. The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients.

Вмешательства

  • Другое Psychological Tests' administration
    to assess global psychological and psychiatric profile of patients affected by GBM and H\&N-C by means of standardized questionnaires

Первичные конечные точки

  • Distress Thermometer [Срок оценки: 18 months]
Вторичные конечные точки (1)
  • Brief Psychiatric Rating Scale [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • Consecutive glioblastoma and head and neck cancer patients undergoing a long course of radiotherapy
  • Patients in adjuvant RT
  • Patients in radiotherapy plus chemotherapy (RTCT) adjuvant regimen
  • Ability to understand and complete the questionnaires
  • Age > 18 years
  • Informed consent signed

Критерии исключения

  • Age > 75 years
  • Glioblastoma and head and neck cancer patients undergoing palliative radiotherapy
  • Patients with inability to express informed consent
  • Patients denying informed consent
  • Patients affected by severe language deficits

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Идентификаторы

NCT: NCT06385132 · 6447

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗