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, 120 participants, IRCCS San Raffaele

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Registry	NCT07843433, acronym IN-TIME
Status	Not yet recruiting
Study type	Observational
Enrollment	120 (Estimated)
Sponsor	IRCCS San Raffaele (Other); collaborators: ASST Santi Paolo e Carlo, Istituto Universitario di Studi Superiori - IUSS, HPA (Health Protection Agency) of the Metropolitan City of Milan, DG Welfare Regione Lombardia, University College, London, Accademia Lombarda di Sanità Pubblica
Conditions	Mental Health, Cancer, Cardiometabolic Diseases
Interventions	Not applicable - observational study (Other)
Dates	start 2026-11-01 (estimated), primary completion 2029-06-01 (estimated), completion 2029-11-01 (estimated), first posted 2026-09-28, last updated 2026-09-28

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
People with severe mental disorders		Other: Not applicable - observational study

Not applicable - observational study (Other): Not applicable - observational study

+Outcome measures

Primary outcomes

Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers [Baseline]: 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).

+Eligibility

Sex: All, ages: 40 Years to 70 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).