Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCristina Renzi
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients under 18 years of age
Patients don't speak the Italian language (for the qualitative study)
Trial 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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable - observational study
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities1 intervention
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
BaselineLocations
Sponsors and contacts
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Cristina Renzi
Lead sponsor
IRCCS San Raffaele
Sponsor institution
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: