Clinical trial NCT04334239: Effectiveness of Care in Certified Cancer Centres in Germany
Official title: Wirksamkeit Der Versorgung in Onkologischen Zentren
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Breast Cancer
Ovarian Cancer
Cervix Cancer
Endometrial Cancer
Bronchial Cancer
Prostate Cancer
Head and Neck Tumor
CNS Tumor
Pancreatic Cancer
Keywords: quality of treatment
institution of treatment
certification
cancer centres
quality of care
treatment outcome
health services research
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg
name: Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT
name: Wissenschaftliches Institut der AOK (WIdO)
First posted: 2020-04-06
Enrollment: 670000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German residents with continuous insurance of one of the AOK funds 2006-2017 and patients recorded in one of the participating cancer registries Dresden, Erfurt, Regensburg and Berlin-Brandenburg 2006-2017

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
measure: 1- and 5-year survival
timeFrame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively
measure: 30-day mortality
timeFrame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up
Secondary outcomes:
measure: 2-, 3-, 4-year survival
timeFrame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively
measure: Recurrence-free survival
timeFrame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
measure: Cumulative recurrence rate
timeFrame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
measure: Complications due to surgery
timeFrame: date of initial cancer surgery with entity-specific follow-up
measure: Successive resection
timeFrame: second resection within three months of initial cancer surgery
measure: Entity-specific outcomes defined by clinical experts
timeFrame: 2009-2017 [CCR] or 2006-2017 [WIdO]
measure: Fraction of patients
timeFrame: 2009-2017
measure: Regional differences
timeFrame: 2009-2017
measure: Differences in patient characteristics
timeFrame: 2009-2017 [CCR] or 2006-2017 [WIdO]
measure: Pathways of treatment
timeFrame: 2009-2017
measure: Severity Levels in insurance data
timeFrame: 2009-2017
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden
state: Sachsen
Study officials:
References:
citation: Roessler M, Schmitt J, Bobeth C, Gerken M, Kleihues-van Tol K, Reissfelder C, Rau BM, Distler M, Piso P, Gunster C, Klinkhammer-Schalke M, Schoffer O, Bierbaum V. Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study. BMC Cancer. 2022 Jun 7;22(1):621. doi: 10.1186/s12885-022-09731-w.