- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479292
Allocating Resources for Cancer Care in Times of the Sars-CoV-2 Outbreak. Health Care Research
Medical Care of Cancer Patients During the COVID-19 Pandemic - an Analysis of Health Insurance Claims Data
Study Overview
Status
Intervention / Treatment
Detailed Description
For a realistic assessment, the situation will be compared with the situation before the Sars-CoV-2 pandemic while considering confounders and effect modifiers. The evaluation is based on pseudonymised routine statutory health insurance (SHI) data of the AOK PLUS for Saxony.
As data sources, SHI data of the AOK PLUS Saxony for the period 2015 to 4th quarter 2020 and publicly available data on COVID19 are used. The differentiation between incidence and prevalent diseases is based on a 4-year washout period, so that the health care situation can be compared between 2019 (pre-period) and 2020 (post-period). Patients with confirmed diagnoses of CRC and PaCa or early detection measures regarding CRC are investigated. These will be contrasted to patients with confirmed diagnoses of T2D, CHD, and MS or early detection measures regarding T2D.
The differentiation of subgroups as confounders or effect modifiers is taken into account. Subgroups are considered with respect to the factors age groups, gender, Elixhauser comorbidities, metastasis y/n, residential regions (postal code 3 digits), characteristics of the treating institution and possibly seasonal effects.
Aims:
Analysis of the differences in the health care provision situation during the Sars-CoV-2 outbreak compared to the time before.
Research questions:
- (How) did the situation of health care for cancer patients change due to the outbreak of Sars-CoV-2? Which changes could be observed in the dimensions access to care, quality or guideline adherence in medical care and outcome?
- Did the focus on COVID19 patients have an impact on the diagnosis or early detection of cancer in Saxony?
- Are the observed effects differential with respect to the diseases, especially when comparing CRC and PaCa with the control group regarding T2D and CHD?
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- ZEGV
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Resident of Saxony, Germany with health insurance coverage provided by AOK PLUS
- Diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis between in 2019 or 2020 according to ICD-10
Exclusion Criteria:
- Change of health insurance provider between 2015 and 2020
- Born after 2014
- Deceased between 2015-2018
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of confirmed diagnoses (new cases of CRC or PaCa)
Time Frame: Comparison of 2019 to 2020
|
Comparison of 2019 to 2020
|
Number of colonoscopies
Time Frame: Comparison of 2019 to 2020
|
Comparison of 2019 to 2020
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of hospitalizations
Time Frame: Comparison of 2019 to 2020
|
Comparison of 2019 to 2020
|
Number of surgeries/systemic therapies related to cancer after onset of disease
Time Frame: Comparison of 2019 to 2020
|
Comparison of 2019 to 2020
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathway of health care
Time Frame: Comparison of 2019 to 2020
|
Comparison of 2019 to 2020
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jochen Schmitt, Dr. med., Technische Universitat Dresden
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CancerCOVID-HCR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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