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NCT Number: NCT06385132

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

LOREDANA DINAPOLI

CONTACT

[email protected]

+390630154428

Loredana Dinapoli

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Distress Thermometer

    Time frame: 18 months

    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').

Secondary outcomes

  1. Brief Psychiatric Rating Scale

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Loredana Dinapoli

CONTACT

[email protected]

+390630154428

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: APPOINT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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