Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— APPOINT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385132
• Other study ID #: 6447
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Loredana Dinapoli
• Phone: +390630154428
• Email: loredana.dinapoli[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: October 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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