Clinical trial NCT06385132: Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer
Official title: GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma
Head and Neck Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Distress Thermometer
timeFrame: 18 months
Secondary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Loredana Dinapoli
role: PRINCIPAL_INVESTIGATOR
References: