Wirksamkeit Der Versorgung in Onkologischen Zentren
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 670,000
- Locations
- 1
- Primary Endpoint
- 30-day mortality
Study Overview
Brief Summary
Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.
Detailed Description
Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.
The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.
WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 [WIdO]
- •hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 [CCR]
Exclusion Criteria
- •prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
- •exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent
Outcomes
Primary Outcomes
30-day mortality
Time Frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up
30-day mortality after first hospitalization due to cancer
Overall survival
Time Frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Survival after first hospitalization due to cancer
1- and 5-year survival
Time Frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively
1- and 5-year survival after first hospitalization due to cancer
Secondary Outcomes
- Pathways of treatment(2009-2017)
- Recurrence-free survival(cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017)
- Complications due to surgery(date of initial cancer surgery with entity-specific follow-up)
- 2-, 3-, 4-year survival(first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively)
- Cumulative recurrence rate(cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017)
- Successive resection(second resection within three months of initial cancer surgery)
- Entity-specific outcomes defined by clinical experts(2009-2017 [CCR] or 2006-2017 [WIdO])
- Severity Levels in insurance data(2009-2017)
- Fraction of patients(2009-2017)
- Regional differences(2009-2017)
- Differences in patient characteristics(2009-2017 [CCR] or 2006-2017 [WIdO])
Investigators
Jochen Schmitt.
Prof. Dr. med. Jochen Schmitt, MPH
Technische Universität Dresden