跳至主要内容
临床试验/NCT06385132
NCT06385132招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
207
试验地点
1
主要终点
Distress Thermometer

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Distress Thermometer

时间窗: 18 months

Distress Thermometer is a visual analogue tool rating personal distress during the past week on a scale from 0 (no distress) to 10 (extreme distress). Compared to psychological questionnaires, which are used as 'gold-standard' reference instruments (i.e., the Hospital Anxiety and Depression Scale), a DT cut-off score ≥ 4 identifies patients with emotional distress ('caseness').

次要结局

  • Brief Psychiatric Rating Scale(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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