Effectiveness of Care in Certified Cancer Centres in Germany

Completed

• Conditions: Bronchial Cancer; Prostate Cancer; Head and Neck Tumor; Ovarian Cancer; Cervix Cancer; CNS Tumor; Colorectal Cancer; Endometrial Cancer; Breast Cancer; Pancreatic Cancer
• Interventions: Other: Oncological certification

• Registration Number: NCT04334239
• Lead Sponsor: Technische Universität Dresden

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Oncological certification	Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre.

Primary Outcome Measures

Name	Time	Method
30-day mortality	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	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Technische Universität Dresden; 🇩🇪 Dresden, Sachsen, Germany