Effectiveness of Care in Certified Cancer Centres in Germany

NCT04334239 | Completed

• 1 other identifier: 01VSF17020
• Study Type: observational
• Target: 670,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

• Recurrence-free survival

  cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017

• Cumulative recurrence rate

  cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017

• Complications due to surgery

  date of initial cancer surgery with entity-specific follow-up

• Successive resection

  second resection within three months of initial cancer surgery

Study Arms (2)

Intervention

Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre.

Other: Oncological certification

Control

Cancer patients who have not undergone inpatient treatment in a certified cancer centre.

Interventions

Oncological certification OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 \[CCR\]

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (2)

• Hansinger J, Schoffer O, Volkel V, Gerken M, Wimberger P, Bierbaum V, Bobeth C, Rossler M, Droge P, Ruhnke T, Gunster C, Kleihues-van Tol K, Link T, Kast K, Papathemelis T, Ortmann O, Schmitt J, Klinkhammer-Schalke M. Comparison of survival in ovarian cancer patients following treatment in certified gynecologic oncology centers and non-certified hospitals: a German retrospective cohort study (WiZen). J Ovarian Res. 2025 Nov 4;18(1):238. doi: 10.1186/s13048-025-01843-8.

  PMID: 41188998 DERIVED

• 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.

  PMID: 35672675 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Carcinoma, Bronchogenic; Prostatic Neoplasms; Head and Neck Neoplasms; Central Nervous System Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Nervous System Neoplasms; Nervous System Diseases; Pancreatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jochen Schmitt, MPH

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: May 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: August 31, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

DE (1)