Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06385132

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-15

207

Participants Needed

1

Research Sites

130 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive glioblastoma and head and neck cancer patients undergoing a long course of radiotherapy
  • Patients in adjuvant radiotherapy
  • Patients receiving radiotherapy plus chemotherapy (RTCT) in adjuvant regimen
  • Ability to understand and complete the questionnaires
  • Age over 18 years
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Age over 75 years
  • Patients undergoing palliative radiotherapy
  • Patients unable to provide informed consent
  • Patients refusing to give informed consent
  • Patients with severe language deficits

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

L

Loredana Dinapoli

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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