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CompletedNCT03521531PROSaUpdated Aug 27, 2021

Burden and Medical Care of Sarcoma in Germany

An observational study in Sarcoma, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by Technische Universität Dresden · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,309
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Sarcoma

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Keywords

  • Quality of Life
  • Sarcoma
  • Patient Reported Outcomes
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 1,309 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All sarcoma patients treated, diagnoses or been in aftercare in a German hospital or medical practice.

Inclusion criteria

  • patients with sarcoma diagnosis according to International Classification of Diseases for Oncology (ICD-O) and World Health Organisation (WHO) classification

Exclusion criteria

Exclusion Criteria:

  • not mentally able to fill out questionaires
  • not able to till out questionaires in German
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,309 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

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Study locations

1 site
  • University Hospital Dresden
    Dresden, Saxony 01307, Germany
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References and documents

Publications

  • Eichler M, Hentschel L, Singer S, Hornemann B, Hohenberger P, Kasper B, Andreou D, Pink D, Jakob J, Arndt K, Kirchberg J, Richter S, Bornhauser M, Schmitt J, Schuler MK. Distress in soft-tissue sarcoma and gastrointestinal stromal tumours patients-Results of a German multicentre observational study (PROSa). Psychooncology. 2022 Oct;31(10):1700-1710. doi: 10.1002/pon.6009. Epub 2022 Aug 18. PubMed 35949152 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03521531
Lead sponsor
Technische Universität Dresden
Responsible party
Markus Schuler (MD, Technische Universität Dresden) — Principal investigator
First posted
May 11, 2018
Start date
Sep 30, 2017
Primary completion
Nov 1, 2019
Completion
Jul 1, 2021
Last update
Aug 27, 2021

Study contacts

Markus Schuler, MD
principal investigator · Technical University Dresden, Medical Faculty
Jochen Schmitt, PhD
principal investigator · Technical University Dresden, Medical Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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