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SarcomaPROSaNCT03521531

Burden and Medical Care of Sarcoma in Germany

An observational study of Sarcoma, run by Technische Universität Dresden at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
How many people
1,309 participants
Where
1 siteGermany
Study dates
30 Sep 2017to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Dresden

    Dresden, Saxony, 01307

Other trials in Germany

About this study

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

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
Medical subject headings
Sarcoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start30 Sep 2017
  3. Primary completion1 Nov 2019
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521531
Sponsor's protocol ID
111713
Acronym
PROSa
Status last verified
Aug 2021
First submitted
30 Apr 2018
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoma, run by Technische Universität Dresden at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life - EORTC QLQ-C30 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.

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