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Clinical Trials in Italy / NCT06385132
Recruiting Observational

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

NCT06385132 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-05-02
Last updated
2025-08-15

Condition(s) studied

GlioblastomaHead and Neck Cancer

Investigational drug(s) / intervention(s)

Psychological Tests' administration

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy Recruiting

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06385132 on ClinicalTrials.gov ↗ ← All trials in Italy