NCT06385132 Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer
| NCT ID | NCT06385132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Glioblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 207 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2026-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 207 participants in total. It began in 2024-05-02 with a primary completion date of 2026-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Loredana Dinapoli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06385132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06385132 currently recruiting?
Yes, NCT06385132 is actively recruiting participants. Contact the research team at loredana.dinapoli@policlinicogemelli.it for enrollment information.
Where is the NCT06385132 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06385132 clinical trial?
NCT06385132 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Loredana Dinapoli at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 207 participants.
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