Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological Tests' administration.
- Who it may be relevant to
- Registry conditions: Glioblastoma, Head and Neck Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients
Overview
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.
Interventions
- 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
Primary outcome measures
- Distress Thermometer [Time frame: 18 months]
Secondary outcome measures (1)
- Brief Psychiatric Rating Scale [Time frame: 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Identifiers
NCT: NCT06385132 · 6447