Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 1
- 主要终点
- See result section upon availability
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with antineoplastic therapy (chemotherapy or "new substances"), radiochemotherapy or radiotherapy in the period 1/1/2021 - 06/30/2021
- •with anemia with hemoglobin levels decreases below 10g/dl (6.2 mmol/l) at least once during the period 1/1/2021 - 06/30/2021
- •with at least 4 weeks of follow up period after anemia diagnosis.
排除标准
- •Follow up time less than 4 weeks,
- •lack of patient contact after anemia diagnosis
结局指标
主要结局
See result section upon availability
时间窗: 06/2021 - 09/2022
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 * iron therapy, * erythropoiesis stimulating agents (ESA) and * transfusion with red blood cells (RBC) depending on various diagnostic parameters and the respective antitumor therapy. The therapy recommendations presented correspond with the recommendations of the Onkopedia guideline on iron deficiency anemia, the S3 guideline on supportive therapy and the cross-sectional guidelines for therapy with blood components and plasma derivatives. 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.
次要结局
未报告次要终点