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

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.

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Key information

Conditions

Disabled Persons Cancer Diagnosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Not applicable- observational study

Other

Not applicable - observational study

Primary outcomes

Diagnostic pathways and oncological outcomes in Patients with Disabilities:

Time frame: Baseline

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.

Secondary outcomes

Accessibility and inclusiveness in Diagnostic Services: Validation of the DfA A.U.D.I.T.

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

Cristina Renzi

Other

Collaborators

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

Registry information

Acronym: MICaDO

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Feb 24, 2025
Registry last updated: Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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