Allocating Resources for Cancer Care in Times of the Sars-CoV-2 Outbreak. Health Care Research

NCT ID: NCT05479292

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Sars-CoV-2 outbreak

Sars-CoV-2 pandemic's impact on provision of healthcare for cancer patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

AOK PLUS

INDUSTRY

Sponsor Role collaborator

Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg

UNKNOWN

Sponsor Role collaborator

Ruhr-Universität Bochum

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jochen Schmitt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

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ZEGV

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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CancerCOVID-HCR

Identifier Type: -

Identifier Source: org_study_id