Burden and Medical Care of Sarcoma in Germany

NCT03521531 | Completed

• 1 other identifier: 111713
• Study Type: observational
• Target: 1,309
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma

Keywords

Quality of Life; Sarcoma; Patient Reported Outcomes

Outcome Measures

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.

  1 year

Secondary Outcomes (2)

• Pain - Intensity (BPI)

  1 year

• Psychological Distress - PHQ-4

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• 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.

  PMID: 35949152 DERIVED

Related Links

• study site with information for participating patients and about recruiting study centers (in German)

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Markus Schuler, MD

  Technical University Dresden, Medical Faculty

  PRINCIPAL INVESTIGATOR

• Jochen Schmitt, PhD

  Technical University Dresden, Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: September 30, 2017
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)