ImprovINg the TIMEly Diagnosis and Treatment of Cancer and Cardio-metabolic Diseases in People With Mental Disorders: Reducing Health Disparities Through Integrated Care

NCT07843433 | Not Yet Recruiting

• 2 other identifiers: CET 262-2026RF-2024-12378662
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

One in five people in Italy has a mental disorder, with depression being the most common and schizophrenia the most severe. People with mental illness have a higher risk of cardio-metabolic and oncologic comorbidities. They also face disparities in accessing appropriate care, with a 20-year life expectancy reduction. IN-TIME will employ an innovative and highly interdisciplinary approach to characterize barriers to healthcare in people with mental illness for informing interventions and enhancing screening, diagnostic pathways and health outcomes. The project will provide: 1) population-based evidence and characterization of disparities in diagnosis and care for cancer and cardio-metabolic disorders; 2) a fine-grained identification of modifiable barriers, such as those relating to stigma and communication; 3) change promoting interventions, including a policy brief to orient clinical guidelines and best practice to reduce stigma, improve doctor-patient communication and optimize care.

Conditions

Mental Health; Cancer; Cardiometabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers

  For the observational cross-sectional part of the study, the investigators will assess barriers to timely access to cancer and cardiometabolic screening, diagnosis and care in adult patients with schizophrenia spectrum disorder, depressive disorder or bipolar disorder. Participants will undergo standardized assessments and an ad-hoc semi-structured interview exploring personal experiences of healthcare access, screening, diagnostic pathways, communication with healthcare professionals, and perceived barriers and facilitators to care. Interviews will be audio-recorded and analysed using qualitative methods and Natural Language Processing (NLP). A total of 120 participants will be enrolled at two sites: IRCCS Ospedale San Raffaele (n=60) and ASST Santi Paolo e Carlo (n=60).

  Baseline

Study Arms (1)

People with severe mental disorders

Other: Not applicable - observational study

Interventions

Not applicable - observational study OTHER

Not applicable - observational study

People with severe mental disorders

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified through outpatient clinics at IRCCS Ospedale San Raffaele and ASST Santi Paolo e Carlo. Eligible participants will be approached and invited to participate in the study and will undergo screening based on predefined eligibility criteria. The target population includes adults aged 40-70 years with schizophrenia spectrum disorder, depressive disorder, or bipolar disorder. A total of 120 participants will be recruited, 60 at each study site, with both sexes included.

You may qualify if:

• Age 40-70 years;
• ICD-10 diagnosis of schizophrenia spectrum disorder (F20-F29), depressive disorder (F32-F33), or bipolar disorder (F31);
• Ability to provide written informed consent.
• Both sexes are eligible.
• Participants recruited at IRCCS Ospedale San Raffaele or ASST Santi Paolo e Carlo.

You may not qualify if:

• Age \<40 years or \>70 years.
• Inability to provide informed consent.
• Absence of an ICD-10 diagnosis of schizophrenia spectrum disorder (F20-F29), depressive disorder (F32-F33), or bipolar disorder (F31).

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Istituto Universitario di Studi Superiori - IUSS: collaborator
• DG Welfare Regione Lombardia: collaborator
• University College, London: collaborator
• ASST Santi Paolo e Carlo: collaborator
• HPA (Health Protection Agency) of the Metropolitan City of Milan: collaborator
• Accademia Lombarda di Sanità Pubblica: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Neoplasms

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Medical Doctor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share