Clinical trial NCT06841263: Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes
Official title: Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Disabled Persons
Cancer Diagnosis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
name: University College, London
name: Accademia Lombarda di Sanità Pubblica
name: DAMA (Disabled Advanced Medical Assistance)
name: LEDHA (League for the Rights of People with Disabilities and the Promotion of Autonomy)
name: HPA (Health Protection Agency) of the Metropolitan City of Milan
First posted: 2025-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic pathways and oncological outcomes in Patients with Disabilities:
timeFrame: Baseline
Secondary outcomes:
measure: Accessibility and inclusiveness in Diagnostic Services: Validation of the DfA A.U.D.I.T.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: