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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Not applicable - observational study

    Other intervention

    Not applicable - observational study

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: People with severe mental disorders1 intervention

Trial outcomes

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).

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

ASST Santi Paolo e Carlo

Collaborator

Istituto Universitario di Studi Superiori - IUSS

Collaborator

HPA (Health Protection Agency) of the Metropolitan City of Milan

Collaborator

DG Welfare Regione Lombardia

Collaborator

University College, London

Collaborator

Accademia Lombarda di Sanità Pubblica

Collaborator

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