Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes (MICaDO)

The MICaDO study is a multi-method study that aims to investigate inclusive cancer diagnosis in people with disabilities and health outcomes. The main objective is to examine variations in cancer diagnosis and outcomes among individuals with psychiatric, intellectual, neurological, and sensory disabilities to develop interventions aimed at improving cancer care. The hypothesis that investigators will investigate is that people with disability are diagnosed with cancer later than people without disability due to a range of barriers, including physical, sensory, cognitive, and social barriers. The study will use a mixed-methods approach, combining quantitative research (electronic health record analysis) and qualitative research (interviews). The total duration of the study is two years.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Diagnosis; Disabled Persons
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified through various sources, including inpatient hospital settings and outpatient clinics. Eligible participants will be approached and invited to participate in the study. A screening process will be conducted to evaluate eligibility based on predefined criteria. Once eligibility is confirmed, participants will be registered for the study and provided with detailed information about the procedures and their rights.

Description

Inclusion Criteria:

Electronic health record study:

• Patients with psychiatric, intellectual, neurological, and sensory disabilities who received care at San Raffaele Hospital of Milan between 2011 and 2024
• Patients without disabilities who received care at San Raffaele Hospital of Milan between 2011 and 2024 (ratio 4:1 of patients without vs. with disabilities)
• Patients with psychiatric, intellectual, neurological, and sensory disabilities recorded in the Lombardy Regional Data Warehouse between 2011 and 2024
• Patients without disabilities recorded in the Lombardy Regional Data Warehouse between 2011 and 2024 (ratio 4:1 of patients without vs. with disabilities)
• Patients aged 18 and over

Qualitative Interviews:

• Patients aged 18 and over with psychiatric, intellectual, neurological, and sensory disabilities who received care at San Raffaele Hospital of Milan, DAMA (Disabled Advanced Medical Assistance) in Territorial Social Health Companies "Santi Paolo e Carlo" and LEDHA (League for the Rights of People with Disabilities and the Promotion of Autonomy) and their caregivers
• Healthcare provider working at San Raffaele Hospital of Milan, DAMA (Disabled Advanced Medical Assistance) in Territorial Social Health Companies "Santi Paolo e Carlo" and general practitioners

Exclusion Criteria:

• Patients under 18 years of age
• Patients don't speak the Italian language (for the qualitative study)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities	Other: Not applicable- observational study; Not applicable - observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic pathways and oncological outcomes in Patients with Disabilities:	For the quantitative part of the study, the investigators will examine several outcomes, each measured separately comparing patients with and without specific disabilities: emergency presentation measured as a binary variable (No/Yes); diagnosis through screening measured as a binary variable (No/Yes); cancer stage at diagnosis measured as an ordinal categorical variable (Stage 1, 2, 3, 4); short-term mortality measured as a percentage rate at 30 days and 90 days from diagnosis. The data will be extracted from electronic health records at San Raffaele Hospital in Milan and the Lombardy Regional Data Warehouse. For the qualitative part of the study, the investigators will perform qualitative interviews with patients/caregivers and healthcare providers from the Lombardy Region. Patients with various types of disabilities will be recruited at the San Raffaele Hospital in Milan and through outreach activities by LEDHA and DAMA.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accessibility and inclusiveness in Diagnostic Services: Validation of the DfA A.U.D.I.T.	The investigators will employ the Design for All (DfA) A.U.D.I.T., a digital platform developed by the Design and Health Lab of the Politecnico di Milano, to examine building performance, focusing on screening and diagnostic services. Specifically, the investigators will evaluate the interaction between physical, sensory, cognitive, and social barriers to validate a DfA tool for improving accessibility, inclusivity, and equity.	Baseline

Collaborators and Investigators

• Sponsor: Cristina Renzi
• Collaborators: University College, London; Politecnico di Milano; Accademia Lombarda di Sanità Pubblica; DAMA (Disabled Advanced Medical Assistance); LEDHA (League for the Rights of People with Disabilities and the Promotion of Autonomy); HPA (Health Protection Agency) of the Metropolitan City of Milan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CET 470-2024; 2024-1740 (Other Grant/Funding Number: Fondazione Cariplo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No