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NCT Number: NCT05479292

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.

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Key information

Conditions

Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZEGV

Dresden, Saxony, 01307, Germany

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sars-CoV-2 outbreak

Other

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

Primary outcomes

  1. Number of confirmed diagnoses (new cases of CRC or PaCa)

    Time frame: Comparison of 2019 to 2020

  2. Number of colonoscopies

    Time frame: Comparison of 2019 to 2020

Secondary outcomes

  1. Number of hospitalizations

    Time frame: Comparison of 2019 to 2020

  2. Number of surgeries/systemic therapies related to cancer after onset of disease

    Time frame: Comparison of 2019 to 2020

Other outcomes

  1. Pathway of health care

    Time frame: Comparison of 2019 to 2020

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • AOK PLUS
  • German Federal Ministry of Education and Research
  • Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg
  • Ruhr University of Bochum

Registry information

Official study title

Medical Care of Cancer Patients During the COVID-19 Pandemic - an Analysis of Health Insurance Claims Data

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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