Effectiveness of Care in Certified Cancer Centres in Germany

Breast Cancer Clinical Trial

— WiZen  

Official title:

Wirksamkeit Der Versorgung in Onkologischen Zentren

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334239
• Other study ID #: 01VSF17020
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2022
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670000
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Bronchial Cancer
• Carcinoma, Bronchogenic
• Cervix Cancer
• CNS Tumor
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Head and Neck Neoplasms
• Head and Neck Tumor
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Technische Universität Dresden	Dresden	Sachsen

Sponsors (4)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Survival after first hospitalization due to cancer	first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Primary	1- and 5-year survival	1- and 5-year survival after first hospitalization due to cancer	first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively
Primary	30-day mortality	30-day mortality after first hospitalization due to cancer	first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up
Secondary	2-, 3-, 4-year survival	2-, 3-, 4-year survival after first hospitalization due to cancer	first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively
Secondary	Recurrence-free survival	Recurrence-free survival after cancer diagnosis	cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Secondary	Cumulative recurrence rate	Cumulative recurrence rate after cancer diagnosis	cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Secondary	Complications due to surgery	Complications due to cancer surgery	date of initial cancer surgery with entity-specific follow-up
Secondary	Successive resection	Second resection due to cancer	second resection within three months of initial cancer surgery
Secondary	Entity-specific outcomes defined by clinical experts	Fractions of entity-specific surgery techniques; For head-neck-tumours: aspiration pneumonia due to swallowing dysfunctions	2009-2017 [CCR] or 2006-2017 [WIdO]
Secondary	Fraction of patients	Fraction of patients in certified centres and in non-certified hospitals over time	2009-2017
Secondary	Regional differences	Differences across outcomes in different counties or federal states	2009-2017
Secondary	Differences in patient characteristics	Differences in demographic characteristics, disease severity and risk factors across certified centres/non-certified hospitals	2009-2017 [CCR] or 2006-2017 [WIdO]
Secondary	Pathways of treatment	Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification	2009-2017
Secondary	Severity Levels in insurance data	Deduction of cancer severity levels through linkage of health insurance and cancer registry data	2009-2017