Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-01 @ 6:10 AM
Study NCT ID:
NCT06385132
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress Thermometer', 'timeFrame': '18 months', 'description': "Distress Thermometer is a visual analogue tool rating personal distress during the past week on a scale from 0 (no distress) to 10 (extreme distress). Compared to psychological questionnaires, which are used as 'gold-standard' reference instruments (i.e., the Hospital Anxiety and Depression Scale), a DT cut-off score ≥ 4 identifies patients with emotional distress ('caseness')."}], 'secondaryOutcomes': [{'measure': 'Brief Psychiatric Rating Scale', 'timeFrame': '18 months', 'description': "The Brief Psychiatric Rating Scale was developed to assess the severity of psychopathology symptoms. Administration times are brief, which makes it appropriate for use in clinical settings.\n\nItems are rated based on the clinician's or interviewer's observation of the patient's behavior, whereas the remaining symptoms are assessed using the information obtained during the interview. For the present protocol, the 24-item version will be used. Possible scores vary from 24 to 168, with lower scores indicating less severe psychopathology."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.\n\nThe 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.\n\nTo 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.\n\nAim 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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\n\nPatients with histologically proven H\\&NC, undergoing external beam radiotherapy with/without concurrent CT and treated by standard regimens will be enrolled in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive glioblastoma and head and neck cancer patients undergoing a long course of radiotherapy\n* Patients in adjuvant RT\n* Patients in radiotherapy plus chemotherapy (RTCT) adjuvant regimen\n* Ability to understand and complete the questionnaires\n* Age \\> 18 years\n* Informed consent signed\n\nExclusion Criteria:\n\n* Age \\> 75 years\n* Glioblastoma and head and neck cancer patients undergoing palliative radiotherapy\n* Patients with inability to express informed consent\n* Patients denying informed consent\n* Patients affected by severe language deficits'}, 'identificationModule': {'nctId': 'NCT06385132', 'acronym': 'APPOINT', 'briefTitle': 'Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients', 'orgStudyIdInfo': {'id': '6447'}}, 'armsInterventionsModule': {'interventions': [{'name': "Psychological Tests' administration", 'type': 'OTHER', 'description': 'to assess global psychological and psychiatric profile of patients affected by GBM and H\\&N-C by means of standardized questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'LOREDANA DINAPOLI', 'role': 'CONTACT', 'email': 'loredana.dinapoli@policlinicogemelli.it', 'phone': '+390630154428'}, {'name': 'Loredana Dinapoli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Loredana Dinapoli', 'role': 'CONTACT', 'email': 'loredana.dinapoli@policlinicogemelli.it', 'phone': '+390630154428'}], 'overallOfficials': [{'name': 'Loredana Dinapoli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}