Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

NCT06385132 | Recruiting

• 1 other identifier: 6447
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Distress Thermometer

  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').

  18 months

Secondary Outcomes (1)

• Brief Psychiatric Rating Scale

  18 months

Interventions

Psychological Tests' administration OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histologically proven isocitrate dehydrogenase 1 wild-type (IDH-1wt) GBM, with either complete or incomplete resection, undergoing external beam radiotherapy with concurrent CT and treated by standard regimen will be enrolled in this study Patients with histologically proven H\&NC, undergoing external beam radiotherapy with/without concurrent CT and treated by standard regimens will be enrolled in this study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site

Study Officials

• Loredana Dinapoli

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loredana Dinapoli

CONTACT

+390630154428; loredana.dinapoli@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 25, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (1)