Effectiveness of Care in Certified Cancer Centres in Germany (WiZen)

Wirksamkeit Der Versorgung in Onkologischen Zentren

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Colorectal Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer; Cervix Cancer; Endometrial Cancer; Bronchial Cancer; Head and Neck Tumor; CNS Tumor
• Intervention / Treatment: Other: Oncological certification

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 Type: Observational
• Enrollment (Actual): 670000

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Technische Universitat Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre.	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.
Control; Cancer patients who have not undergone inpatient treatment in a certified cancer centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Complications due to surgery	Complications due to cancer surgery	date of initial cancer surgery with entity-specific follow-up
Successive resection	Second resection due to cancer	second resection within three months of initial cancer surgery
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]
Fraction of patients	Fraction of patients in certified centres and in non-certified hospitals over time	2009-2017
Regional differences	Differences across outcomes in different counties or federal states	2009-2017
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]
Pathways of treatment	Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification	2009-2017
Severity Levels in insurance data	Deduction of cancer severity levels through linkage of health insurance and cancer registry data	2009-2017

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: quality of care; treatment outcome; quality of treatment; institution of treatment; certification; cancer centres; health services research
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Neoplasms; Lung Neoplasms; Uterine Cervical Neoplasms; Head and Neck Neoplasms; Endometrial Neoplasms; Carcinoma, Bronchogenic
• Other Study ID Numbers: 01VSF17020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No