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NCT06385132Recruiting

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
207 (estimated)
First submitted
5 Apr 2024
Start date
2 May 2024
Primary completion date
31 Dec 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06385132

What you commit to

  • Study type: Observational
  • Planned participants: 207
  • From 2 May 2024 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Glioblastoma and head and neck cancer patients undergoing palliative radiotherapy

Age

  • Age \> 75 years

Other

  • Patients with inability to express informed consent
  • Patients denying informed consent
  • Patients affected by severe language deficits

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.