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Effectiveness of Care in Certified Cancer Centres in Germany

Wirksamkeit Der Versorgung in Onkologischen Zentren

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04334239
Acronym
WiZen
Enrollment
670000
Registered
2020-04-06
Start date
2017-05-01
Completion date
2021-08-31
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Bronchial Cancer, Cervix Cancer, CNS Tumor, Colorectal Cancer, Endometrial Cancer, Head and Neck Tumor, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer

Keywords

quality of treatment, institution of treatment, certification, cancer centres, quality of care, treatment outcome, health services research

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.

Interventions

OTHEROncological certification

Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.

Sponsors

Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg
CollaboratorUNKNOWN
Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT
CollaboratorUNKNOWN
Wissenschaftliches Institut der AOK (WIdO)
CollaboratorUNKNOWN
Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalfirst hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017Survival after first hospitalization due to cancer
1- and 5-year survivalfirst hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively1- and 5-year survival after first hospitalization due to cancer
30-day mortalityfirst hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up30-day mortality after first hospitalization due to cancer

Secondary

MeasureTime frameDescription
Complications due to surgerydate of initial cancer surgery with entity-specific follow-upComplications due to cancer surgery
Successive resectionsecond resection within three months of initial cancer surgerySecond resection due to cancer
Entity-specific outcomes defined by clinical experts2009-2017 [CCR] or 2006-2017 [WIdO]1. Fractions of entity-specific surgery techniques 2. For head-neck-tumours: aspiration pneumonia due to swallowing dysfunctions
Fraction of patients2009-2017Fraction of patients in certified centres and in non-certified hospitals over time
2-, 3-, 4-year survivalfirst hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively2-, 3-, 4-year survival after first hospitalization due to cancer
Differences in patient characteristics2009-2017 [CCR] or 2006-2017 [WIdO]Differences in demographic characteristics, disease severity and risk factors across certified centres/non-certified hospitals
Pathways of treatment2009-2017Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification
Severity Levels in insurance data2009-2017Deduction of cancer severity levels through linkage of health insurance and cancer registry data
Regional differences2009-2017Differences across outcomes in different counties or federal states
Recurrence-free survivalcancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017Recurrence-free survival after cancer diagnosis
Cumulative recurrence ratecancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017Cumulative recurrence rate after cancer diagnosis

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026