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

NCT06841263 | Not Yet Recruiting

• 2 other identifiers: CET 470-20242024-1740
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Disabled Persons; Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline

Study Arms (1)

Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable - observational study

Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor and Medical Doctor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03