MEOP - Multidimensional Evaluations in Oncological Psychiatry (MEOP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychiatric Disorder; Adverse Drug Event; Family Members; Treatment Compliance; Cognition Disorder
• Intervention / Treatment: Behavioral: Psychiatric and neuropsychological evaluation through rating scales

Detailed Description

Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level. While considerable advances have been made in understanding and treating the biological aspects of cancer, its psychological and psychiatric impacts remain a major concern. Psychiatric disorders, including depression, anxiety, post-traumatic stress disorder (PTSD), and adjustment disorders, are frequently observed in cancer patients. These disorders are not only common but also underdiagnosed, as their symptoms are often misinterpreted as normal emotional reactions to the illness. This misperception undermines the recognition of significant psychiatric conditions that require targeted interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. For instance, stress and depression can directly affect tumour biology through neuroendocrine and immune mechanisms, including increased inflammatory responses and dysregulated cortisol levels, via the chronic activation of the Hypothalamic-Pituitary-Adrenal axis (HPA). Indirectly, psychiatric symptoms can impair treatment adherence and lead to lifestyle choices that increase the risk of recurrence, such as poor nutrition, lack of physical activity, or substance use.

The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, dysregulation of biology in cancer patients might confer greater vulnerability to psychiatric disorders. 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, including IL-6, TNF-α, CRP, and IL-1ra. 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. Since tumour-related inflammation emerges early in the progression of cancer, depression and other psychological symptoms might manifest as initial indicators of the disease.

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 is crucial. However, there are several difficulties in assessing these patients. First, there is a need to better understand the psychopathology behind cancer. Frequently, symptoms like depression and anxiety are conceived as normal reactions to cancer, whereas cancer can trigger severe syndromes, which are frequently overlooked. Second, studies related to common biological patterns linking cancer and psychiatric disorders are poorly investigated. Furthermore, there is a lack of studies that assess the effectiveness and safety of pharmacological and non-pharmacological treatments in these patients.

Family members of cancer patients experience significant emotional and psychological strain, yet their psychiatric symptoms are often overlooked. The biological underpinnings of these symptoms in caregivers, as well as effective treatments tailored to this population, are under-researched. Addressing the mental health needs of families is essential to improving overall care outcomes in oncology.

This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.

• Study Type: Observational
• Enrollment (Estimated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; any subject affected by cancer with a comorbid psychiatric disorder	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. 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.; Other Names: Medical evaluation and blood testing.
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; 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.; Other Names: Medical evaluation and blood testing.
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; 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.; Other Names: Medical evaluation and blood testing.
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; 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.; Other Names: Medical evaluation and blood testing.
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; 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.; Other Names: Medical evaluation and blood testing.
control-rel; First-degree relatives of "oncology-controls", "psy-controls" and "healthy controls"	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. 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.; Other Names: Medical evaluation and blood testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychiatric differences	Evaluate psychiatric differences among cases and controls over the time	January 2026 - January 2035

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics course over time	Evaluate differences of certain demographical characteristics among cases and controls over time	January 2026 - January 2035
Medical characteristics course over time	Evaluate presence/absence of certain medical characteristics among cases and controls over time	January 2026 - January 2035
Biological characteristics course over time	Evaluate presence/absence of certain biological characteristics among cases and controls over time	January 2026 - January 2035
Neuropsychological characteristics course over time	Evaluate presence/absence of certain neuropsychological characteristics among cases and controls over time	January 2026 - January 2035
Differences in psychiatric symptoms in subjects under different medications	Evaluate differences in presence/absence of certain psychiatric symptoms among subjects under certain medications and their course over time	January 2026 - January 2035
Differences in psychiatric rating scales in subjects under different medications	Evaluate differences in scores of psychiatric rating scales among subjects under certain medications and their course over time	January 2026 - January 2035
Differences in biological characteristics and their course over time	Evaluate differences among cases and controls over time in levels of C-reactive protein, erythrocyte sedimentation rate, interleukines, vitamin D, folate, vitamin B12, iron, ferritin, transferrin, total iron-binding capacity, glucose, insulin, glycated hemoglobin, triglycerides, cholesterol , apolipoproteins, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, bilirubin, glomerular filtration rate, uric acid, sodium, potassium, chloride, calcium, magnesium, phosphorus, cortisol, adrenocorticotropic hormone, prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen, white blood cell count, red blood cell count, hemoglobin, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, neutrophil-to-lymphocyte ratio, and albumin and prealbumin levels.	January 2026 - January 2035
Biological differences in subjects under different medications	Evaluate differences and their course over time of the following biological parameters: C-reactive protein, erythrocyte sedimentation rate, interleukines, vitamin D, folate, vitamin B12, iron, ferritin, transferrin, total iron-binding capacity, glucose, insulin, glycated hemoglobin, triglycerides, cholesterol , apolipoproteins, transaminases, alkaline phosphatase, bilirubin, glomerular filtration rate, uric acid, sodium, potassium, chloride, calcium, magnesium, phosphorus, cortisol, adrenocorticotropic hormone, prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen, white blood cell count, red blood cell count, hemoglobin, platelet count, neutrophil-to-lymphocyte ratio, and albumin and prealbumin levels. Comparisons will be made in subjects undergoing different medicatiosns such as antidepressants, mood stabilizers, antipsychotics, benzodiazepines, stimulants.	January 2026 - January 2035
Side effects	Compare rates of side effects related to different classes of pharmacological treatments.	January 2026 - January 2035
Correlations between biology and neuropsychology and illness burden	Correlate alterations of neuropsychology and biological markers (inflammatory cytokines and blood cells count,) with severity of psychiatric symptoms at T0 and the evolution of these relationships over time.	January 2026 - January 2035

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): January 29, 2036
• Study Completion (Estimated): January 29, 2036

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurocognitive Disorders; Chemically-Induced Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Cognition Disorders; Patient Compliance; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Behavioral Disciplines and Activities; Behavioral Sciences; Hematologic Tests; Psychiatry
• Other Study ID Numbers: 7944

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No