Burden and Medical Care of Sarcoma in Germany

Study Overview
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Brief Summary
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The main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons. Impaired quality of life domains and factors associated with it are to be identified. To this end, a national network of sarcoma treatment specialists and a structure for patient recruitment will be established. This care network is intended to reflect the current situation of the treatment of sarcoma patients in Germany.

Official Title
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Burden and Medical Care of Sarcoma in Germany: Nationwide Cohort Study Focusing on Modifiable Determinants of Patient-Reported Outcome Measures in Sarcoma Patients

Conditions
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Sarcoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with sarcoma diagnosis according to International Classification of Diseases for Oncology (ICD-O) and World Health Organisation (WHO) classification Exclusion Criteria: not mentally able to fill out questionaires not able to till out questionaires in German

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - EORTC QLQ-C30 | Measured with European Organization for Research and Treatment of Cancer Quality of Life Core Questionaire (EORTC QLQ-C30). The questionnaire consists of 30 questions assessing general quality of life issues of cancer patients. The EORTC QLQ-C30 includes 5 functional scales, measuring physical, role, emotional, cognitive, and social functioning, three multi-item symptom scales (fatigue, nausea/vomiting, and pain), and six single-item scales. High scores on the functional and global scales represent better quality of life. In contrast, high scores on the symptom scale indicate poor quality of life. Each instrument can reach values from 0-100. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Intensity (BPI) | Measured with Brief Pain Inventory (BPI). The BPI gives two scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score consists of seven subitems rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. | 1 year | 
| Psychological Distress - PHQ-4 | Measured with the Patients Health Questionnaire (PHQ-4). The PHQ-4 comprises 4 items and consists of the diagnostic core criteria for depression (PHQ-2) and for generalized anxiety disorders (GAD-2). Each instrument can reach values from 0-6. Higher Scores are indicating higher distress. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Sarcoma, Patient Reported Outcomes