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| Name | Class |
|---|---|
| Prof. Hartmut Link | UNKNOWN |
| MMF GmbH | INDUSTRY |
| AIO AG Supportivtherapie | OTHER |
| AG Supportive Maßnahmen in der Onkologie |
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The aim of the study is to analyze the implementation of the 2018 updated ESMO Guideline in patients with tumor diseases as well as the corre-sponding recommendations of the Onkopedia Guideline and the S3 Guide-line Supportive Therapy in routine clinical practice in Germany.
To this end, a nationwide, representative, retrospective patient documen-tation will be conducted to observe the current practice of anemia man-agement in hospitals and among office-based physicians.
Health care structure analysis and recruitment (phase 1):
In a first step, data on care facilities treating patients in the above indica-tions in Germany will be collected (gastroenterology, gynecology, hema-tology/oncology, and pneumology hospital departments, as well as of-fice-based hematologists/oncologists and gynecology oncologists).
In Phase 1, all centers in Germany potentially treating patients in the above entities will be contacted and data on the care level of the institu-tion and the number of patients treated will be collected using a one-page pen-to-paper form. In addition, the willingness of the care facilities to participate in the documentation of patients will be surveyed (Phase 2).
Analysis of patient records (phase 2)
In order to obtain a reliable, representative sample of patients treated in Germany, the distribution of the cases to be documented in the individual indications among the participating facilities is determined. For this pur-pose, the data collected from the facilities in Phase I on patient numbers and treatment structure will be used:
Participating centers are divided into clusters based on key distinguishing characteristics (facility type, level of care, and number of patients treat-ed). This sample is modulated according to the previous care structure analysis. This approach allows the actual percentages of the different care facilities in an indication area to be proportionally included in the patient documentation sample.
In Phase 2, a multi-page electronic case record form (eCRF) will be com-pleted to collect patient and treatment data relevant to the purpose of the study. All data will be collected retrospectively and anonymously from patient records.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional retrospective epidemiological observational study | Other | non-interventional retrospective epidemiological observational study |
| Measure | Description | Time Frame |
|---|---|---|
| See result section upon availability | The ESMO Guideline "Management of Anemia and Iron Deficiency in Patients with Cancer", updated in 2018, provides a dedicated algorithm to guide decision-making in the diagnosis and treatment of anemia in tumor patients in order to reduce anemia-related complications. This includes recommendations on
To this end, this study examines the common practice of adherence to the algorithm of guideline adherence by reviewing the above criteria such as iron therapy, use of ESA and RBC substitution. | 06/2021 - 09/2022 |
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Inclusion Criteria:
Patients
Exclusion Criteria:
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Patients with solid tumors or malignant lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Hartmut Link, Prof. Dr. | AIO AG Supportive Therapie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studienzentrum Prof. Dr. med. Hartmut Link, Facharzt für Innere Medizin, Hämatologie und Internistische Onkologie | Kaiserslautern | 67661 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38240843 | Derived | Link H, Kerkmann M, Holtmann L, Detzner M. Anemia diagnosis and therapy in malignant diseases: implementation of guidelines-a representative study. Support Care Cancer. 2024 Jan 19;32(2):113. doi: 10.1007/s00520-023-08267-4. |
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Data is collected retrospectively and completely anonymously from patient records, no identifying characteris-tics (e.g. birth date, initial letters, pseudonym) will be collected.
It is hoped that these data will assist in creating new possibilities and ways to improve the quality of treatment through further training and enhancement of the availability and transparency of the guidelines.
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| OTHER |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |