Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma

NCT ID: NCT05190263

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1053 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-02-06

Brief Summary

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.

Detailed Description

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.

• Patient- and disease-related variables (age, ECOG performance status, staging, relevant comorbidities).
• Drug therapy (chemotherapy, antibodies, immunotherapy, kinase inhibitors: Start/end, substances or regimens).
• Radiotherapy (start/end, irradiated region)
• Laboratory diagnostics (if available) with Hb, Hk, MCV, MCH, re-ticulocytes and/or Ret-Hb, ferritin, transferrin and/or transferrin saturation (TSAT), holo-trans-cobalamin (vitamin B12), folic acid, zinc protoporphyrin, creatinine clearance (GFR), EPO level
• Data on anemia therapy (transfusion of RBC; iron therapy p.o. or i.v.; ESA). To ensure data quality, the scientific project lead will train two employees of the commissioned institute in content-related issues of the study. This knowledge will be incorporated into the programming of the user inter-face and the patient databases so that the program will check for com-pleteness and, as far as possible, plausibility based on defined require-ments and framework conditions. These checks accompany the process of data entry into the eCRF and enable immediate validation of the data.

Conditions

Anemia, Iron Deficiency; Solid Tumor; Malignant Lymphoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

non-interventional retrospective epidemiological observational study

non-interventional retrospective epidemiological observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients

• 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.

Exclusion Criteria

• Follow up time less than 4 weeks,
• lack of patient contact after anemia diagnosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Hartmut Link

UNKNOWN

Sponsor Role: collaborator

MMF GmbH

INDUSTRY

Sponsor Role: collaborator

AIO AG Supportivtherapie

OTHER

Sponsor Role: collaborator

AG Supportive Maßnahmen in der Onkologie

OTHER

Sponsor Role: collaborator

AIO-Studien-gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hartmut Link, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

AIO AG Supportive Therapie

Locations

Studienzentrum Prof. Dr. med. Hartmut Link, Facharzt für Innere Medizin, Hämatologie und Internistische Onkologie

Kaiserslautern, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 38240843 (View on PubMed)

Other Identifiers

AIO-SUP-0121

Identifier Type: -

Identifier Source: org_study_id