Skip to main content
Clinical Trials/NCT06385132
NCT06385132
Recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country207 target enrollmentMay 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioblastoma
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
207
Locations
1
Primary Endpoint
Distress Thermometer
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2024
End Date
October 31, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Distress Thermometer

Time Frame: 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').

Secondary Outcomes

  • Brief Psychiatric Rating Scale(18 months)

Study Sites (1)

Loading locations...

Similar Trials