[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624167":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"any subject affected by cancer with a comorbid psychiatric disorder",[13],"Behavioral: Psychiatric and neuropsychological evaluation through rating scales",{"label":15,"type":10,"description":16,"interventionNames":17},"cases-rel","any first-degree relative of a subject of a \"case\" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"oncology-controls","Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"psy-controls","subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"healthy controls","Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"control-rel","First-degree relatives of \"oncology-controls\", \"psy-controls\" and \"healthy controls\"",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BEHAVIORAL","Psychiatric and neuropsychological evaluation through rating scales","Psychiatric evaluation: a) assessment of previous psychiatric history and family history; b) assessment of the presence of a psychiatric syndrome;c) evaluation of mental status; d) evaluation and documentation of psychopharmacological and psychotherapeutic treatments assumed; e) documentation of any side effects related to treatment.\n\nAdministration of psychiatric rating scales. Clinical evaluation: a) collection of medical history; b) recording of chemo- or radiotherapy assumed and current pharmacological treatments; c) physical examination.\n\nBlood samples Neuropsychological evaluation that will include a series of tests investigating different neurocognitive domains.",[9,15,31,27,19,23],[41],"Medical evaluation and blood testing.",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100624167","meop---multidimensional-evaluations-in-oncological-psychiatry-100624167",false,"NCT07406113","MEOP - Multidimensional Evaluations in Oncological Psychiatry","MEOP","Inclusion Criteria:\n\n* For cases: any subject affected by cancer with a comorbid psychiatric disorder (further defined as \"cases\") or any first-degree relative of a subject of a \"case\" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder). These first-degree relatives will be defined as \"cases-rel\".\n* For controls: a) Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms (further defined as \"oncology-controls\"); b) subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms (further defined as \"psy-controls\"); c) Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation (further defined as \"healthy controls\"); d) First-degree relatives of \"oncology-controls\", \"psy-controls\" and \"healthy controls\" (further defined as \"control-rel\").\n* Age between 18 and 75 years.\n* Capability of providing written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or inability to provide written informed consent.\n* Severe unstable neurological disorders, such as traumatic brain injury, Alzheimer's Disease or dementia.\n* Inability to perform psychiatric or neuropsychological evaluations.",true,"ALL","18 Years","75 Years",{"count":56,"type":57},2000,"ESTIMATED","OBSERVATIONAL","Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes.\n\nThe pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss.\n\nMoreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.\n\nCancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.\n\nGiven the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.",[61,62,63,64,65],"Psychiatric Disorder","Cognition Disorder","Treatment Compliance","Adverse Drug Event","Family Members","NOT_YET_RECRUITING","2026-02-09",{"date":69,"type":70},"2026-02-12","ACTUAL",{"date":72,"type":57},"2026-01-30",{"date":74,"type":57},"2036-01-29",{"name":5,"class":6}]