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Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Study acronym: APPOINT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Aug 12, 2026 → Dec 31, 2027
See other at-risk trials from Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Aug 12, 2026 to Dec 31, 2027 Show 4 more changesShow less
    • Study completion pushed from Oct 31, 2026 to Sep 1, 2028
    • Interventions: Psychological Tests' administration (Other) to Psychological Tests' administration (Other)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 30, 2025 to Aug 12, 2026
    • Study completion date: Oct 31, 2025 to Oct 31, 2026
    • Start date changed from estimate of Apr 15, 2024 to May 2, 2024
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06385132
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Glioblastoma, Head and Neck Cancer
Related terms Glioblastoma, Head and Neck Neoplasms
Enrollment 207 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov