Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-02

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predicting Psychotic Relapse Using Speech-Based Early Detection

NCT06978894

Psychosis

RECRUITING

Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients

NCT01487291

Insulin Resistance Thrombophilia Psychosis

COMPLETED

Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

NCT03649581

Schizophrenia

RECRUITING NA

Evaluation of the Role of Neurodegeneration in Schizophrenia

NCT05257720

Schizophrenia

COMPLETED

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

NCT02594696

Major Depression Schizophrenia Bipolar Disorder +5 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychological Tests' administration

to assess global psychological and psychiatric profile of patients affected by GBM and H\&N-C by means of standardized questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No