Effectiveness of Care in Certified Cancer Centres in Germany

Study Overview
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Brief Summary
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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
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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.

Official Title
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Wirksamkeit Der Versorgung in Onkologischen Zentren

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

Intervention / Treatment
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* Other: Oncological certification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre. | Other: Oncological certification<br>* Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.<br>|
| Control<br>Cancer patients who have not undergone inpatient treatment in a certified cancer centre. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of treatment, institution of treatment, certification, cancer centres, quality of care, treatment outcome, health services research