Disabled PersonsMICaDONCT06841263
Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes
An observational study of Disabled Persons and Cancer Diagnosis, run by Cristina Renzi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disabled Persons, Cancer Diagnosis
- What is being tested?
- Not applicable- observational study
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Patients under 18 years of age
- Patients don't speak the Italian language (for the qualitative study)
About this study
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
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable - observational study
| Study group | Role | What they receive |
|---|---|---|
| Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities | Not described Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabled PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristina Renzi
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, University College, London, 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
- Responsible party
- Sponsor-investigator, Cristina Renzi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841263
- Sponsor's protocol ID
- CET 470-2024
- Other IDs
- 2024-1740
- Acronym
- MICaDO
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-methods Study on Inclusive Cancer Diagnosis in People with Disabilities and Health Outcomes
- ClinicalTrials.gov ID
- NCT06841263
- Acronym / sponsor ID
- MICaDO / CET 470-2024
- Conditions
- Disabled Persons, Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cristina RenziUniversity, hospital or other
- Collaborators
- Politecnico di Milano, University College, London, 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 start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities | – | Other: Not applicable- observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients don't speak the Italian language (for the qualitative study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable - observational study | Other | Peoplewith psychiatric, intellectual, neurological, sensory and physical disabilities |
Primary outcome
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.
1 secondary outcome
Accessibility and inclusiveness in Diagnostic Services: Validation of the DfA A.U.D.I.T.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Related trials for Disabled Persons
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Active, not recruitingPhase 3
Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania
Sexual and Reproductive Health, Disability
Recruiting
PRACOH Prevention Breakdown Support Advice Guidance Disability
Person With a Disability, Caregiver
RecruitingObservational study
mSCI: Mobile Health App for Veterans With SCI and Caregivers
Spinal Cord Injuries (SCI), Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disabled Persons and Cancer Diagnosis, run by Cristina Renzi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic pathways and oncological outcomes in Patients with Disabilities: (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.