MEOP - Multidimensional Evaluations in Oncological Psychiatry

NCT07406113 | Not Yet Recruiting

• 1 other identifier: 7944
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. The 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. Moreover, 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. Cancer 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. Given 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.

Conditions

Psychiatric Disorder; Cognition Disorder; Treatment Compliance; Adverse Drug Event; Family Members

Outcome Measures

Primary Outcomes (1)

• Psychiatric differences

  Evaluate psychiatric differences among cases and controls over the time

  January 2026 - January 2035

Secondary Outcomes (10)

• Demographic characteristics course over time

  January 2026 - January 2035

• Medical characteristics course over time

  January 2026 - January 2035

• Biological characteristics course over time

  January 2026 - January 2035

• Neuropsychological characteristics course over time

  January 2026 - January 2035

• Differences in psychiatric symptoms in subjects under different medications

  January 2026 - January 2035

Study Arms (6)

Cases

any subject affected by cancer with a comorbid psychiatric disorder

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

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

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

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

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

psy-controls

subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

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

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

control-rel

First-degree relatives of "oncology-controls", "psy-controls" and "healthy controls"

Behavioral: Psychiatric and neuropsychological evaluation through rating scales

Interventions

Psychiatric and neuropsychological evaluation through rating scales BEHAVIORAL

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. Administration 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. Blood samples Neuropsychological evaluation that will include a series of tests investigating different neurocognitive domains.

Also known as: Medical evaluation and blood testing.

Cases; cases-rel; control-rel; healthy controls; oncology-controls; psy-controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The Clinical and Emergency Psychiatry Unit and provides outpatient psychiatric assessments and consultations in inpatients wards and day hospitals of the aforementioned institution. Subjects will undergo a first psychiatric evaluation by a clinician of the aforementioned unit. Then, the subject will be assigned to one of the study groups (see above).

You may qualify if:

• 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".
• 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").
• Age between 18 and 75 years.
• Capability of providing written informed consent.

You may not qualify if:

• Severe cognitive impairment or inability to provide written informed consent.
• Severe unstable neurological disorders, such as traumatic brain injury, Alzheimer's Disease or dementia.
• Inability to perform psychiatric or neuropsychological evaluations.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Mental Disorders; Cognition Disorders; Patient Compliance; Drug-Related Side Effects and Adverse Reactions

Interventions

Psychiatry; Hematologic Tests

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 12, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 29, 2036
• Study Completion (Estimated): January 29, 2036
• Last Updated: February 12, 2026

Record last verified: 2026-01