2019-01-01
2020-12-31
2020-12-31
6500
NCT05479292
Technische Universität Dresden
Technische Universität Dresden
OBSERVATIONAL
Allocating Resources for Cancer Care in Times of the Sars-CoV-2 Outbreak. Health Care Research
The focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. To draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the Sars-CoV-2 pandemic. This will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (CRC) and pancreatic cancer (PaCa) in Saxony. Patients with diagnosis, treatment or early detection measures for type 2 diabetes (T2D), coronary heart disease (CHD) and multiple sclerosis (MS) serve as comparison groups.
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: 1. (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? 2. Did the focus on COVID19 patients have an impact on the diagnosis or early detection of cancer in Saxony? 3. Are the observed effects differential with respect to the diseases, especially when comparing CRC and PaCa with the control group regarding T2D and CHD?
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-07-28 | N/A | 2022-07-28 |
2022-07-28 | N/A | 2022-07-29 |
2022-07-29 | N/A | 2022-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of confirmed diagnoses (new cases of CRC or PaCa) | Comparison of 2019 to 2020 | |
| Number of colonoscopies | Comparison of 2019 to 2020 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of hospitalizations | Comparison of 2019 to 2020 | |
| Number of surgeries/systemic therapies related to cancer after onset of disease | Comparison of 2019 to 2020 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
4 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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