Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-05
Brief Title:
Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPOINT
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 HN-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 HN-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 HN-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 HN-C and GBM patients
Patients with head and neck cancer HN-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 HN-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 HN-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 HN-C and GBM patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None