NCT04071704Completed
Assessing Health-related Quality of Life in Sarcoma Patients
Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
Although the clinical effectiveness of sarcoma treatment has improved, long-lasting and cumulative treatment side-effects may often detract from the overall marginal advantage. Information only on survival is insufficient to determine the net clinical benefit of a treatment. It is important to assess treatment effectiveness both in terms of objective outcomes (e.g., response, recurrence and survival) and in terms of subjective patient reported outcomes (PROs), objective functional outcomes including health-related quality of life (HRQoL). Previous studies have predominantly used generic HRQoL instruments, which cover some relevant issues but do not capture all the unique experiences of patients with sarcoma, and thus lack content validity. A sarcoma-specific questionnaire should be able to detect, with more sensitivity, side-effects, symptoms and problems with function that are particularly relevant to patients with sarcoma. To date , there is no specific sarcoma HRQoL instrument available; and, given the heterogeneity of the disease in terms of subtype, location, age and treatment, the development of such an instrument may be challenging. The aim of this collaborative project between the EORTC Quality of Life Group (QLG) and the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) is to raise the standard of HRQoL measurement in patients with sarcoma. An important question remains to be answered: Is it possible to develop one PROs questionnaire covering HRQoL issues that are relevant to all adult patients with sarcoma, or are the HRQoL issues related to the different localization / treatment sufficiently different to warrant the creation of separate item lists selected from the EORTC QLG Item Library?
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 654 (actual)
- First submitted
- 8 Aug 2019
- Start date
- 1 May 2019
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Sarcoma
- NCT number
- NCT04071704
What you commit to
- Study type: Observational
- Participants enrolled: 654
- From 1 May 2019 to the primary completion date, 30 Aug 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having any psychiatric condition or cognitive impairment that would hamper participation in interview/completion of self-reported questionnaires.
- Patients with a Gastrointestinal Stroma Tumour (GIST) diagnosis, as they are quite unique in terms of type of disease and treatment.
- Patients with Kaposi sarcoma, as this disease occurs quite often in people with AIDS
- Patients with Carcinosarcoma as this disease is generally seen as a carcinoma
Who the study is looking for
- Age at diagnosis 18 years or older
- Having a confirmed diagnosis of sarcoma
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Johannes Gutenberg University Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Kiing Hussein Cancer Centre Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.