跳至主要内容
临床试验/NCT07843433
NCT07843433尚未招募不适用

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

IRCCS San Raffaele0 个研究点目标入组 120 人开始时间: 2026年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers

研究概览

简要总结

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.

研究设计

研究类型
观察性
观察模型
其他
时间视角
回顾性

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

People with severe mental disorders

干预措施: Not applicable - observational study (Other)

结局指标

主要结局

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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Cristina Renzi

Associate Professor and Medical Doctor

IRCCS San Raffaele

标识符

NCT 编号
NCT07843433
其他研究编号
CET 262-2026, RF-2024-12378662

日期

首次提交
(9天前)
首次发布
(前天)
主要完成日期
(2年后)
研究完成日期
(3年后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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