Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer (APPOINT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Glioblastoma
• Intervention / Treatment: Other: Psychological Tests' administration

• Study Type: Observational
• Enrollment (Estimated): 207

Contacts and Locations

• Study Contact: Name: LOREDANA DINAPOLI; Phone Number: +390630154428; Email: loredana.dinapoli@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: LOREDANA DINAPOLI; Phone Number: +390630154428; Email: loredana.dinapoli@policlinicogemelli.it
    • Principal Investigator: Loredana Dinapoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Psychiatric Rating Scale	The Brief Psychiatric Rating Scale was developed to assess the severity of psychopathology symptoms. Administration times are brief, which makes it appropriate for use in clinical settings. Items are rated based on the clinician's or interviewer's observation of the patient's behavior, whereas the remaining symptoms are assessed using the information obtained during the interview. For the present protocol, the 24-item version will be used. Possible scores vary from 24 to 168, with lower scores indicating less severe psychopathology.	18 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Loredana Dinapoli, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Head and Neck Neoplasms
• Other Study ID Numbers: 6447 (Saskatchewan Health Research Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No