SarcomaNCT04071704
Assessing Health-related Quality of Life in Sarcoma Patients
An observational study of Sarcoma, run by The Netherlands Cancer Institute at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- How many people
- 654 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 May 2019to 1 Sep 2024
- 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: Adults with sarcoma, with all stages of disease. The primary types of treatments to be included, depending on sarcoma subtype, are chemotherapy/targeted therapy, radiotherapy, surgery, or a combination of these.
Who may be able to join
- Age at diagnosis 18 years or older
- Having a confirmed diagnosis of sarcoma
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
University Hospital Carl Gustav Carus
Dresden
Johannes Gutenberg University Mainz
Mainz
About this study
Official title: Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
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?
Read the detailed description
The investigators will follow the EORTC QLG questionnaire development guidelines. First, a computerized search of the academic literature will be performed to identify all relevant HRQoL issues for and existing HRQoL questionnaires currently used among patients with sarcoma. In parallel, semi-structured interviews will be conducted worldwide with patients with sarcoma(N=179) and health care professionals (HCPs; N=35; phase 1a). The patient sample will be stratified to capture diversity across the sarcoma population tumour location (extremities, axial, head and neck, thorax, retroperitoneal/intra-abdominal and gynecological), stage (localized vs. metastatic disease ) and type or lines of treatment .
This list of HRQoL issues generated by the a) literature search, b) relevant items from the Item Library, and c) semi-structured patient and HCP interviews, and will be consolidated into a comprehensive list of issues for all languages of collaborating countries.
In phase 1b, the new list of HRQoL issues will be presented to another group of patients with sarcoma(N=475) and HCPs (N=72). Patients and HCPs will be asked to rate the HRQoL issues on relevance (4point Likert scale) and to prioritize the 10 most important issues.
- Conditions
- Sarcoma
- Keywords
- health-related quality of life, life satisfaction, treatment-related effects, quality of life measure
- Medical subject headings
- Sarcoma, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have been or are being treated for sarcoma. | |
| Health care professionals | Health care professionals with extensive experience in sarcoma care (medical oncologists, radiation oncologists, surgical oncologists, orthopaedic surgeons, nurse specialists, psychologists, physiotherapists) |
What is being measured
The primary outcome is the main question the study is designed to answer.
a framework for a HRQoL measure for patients with sarcoma
the framework will outline which strategy to adopt for HRQoL in patients with sarcoma: the EORTC Quality of Life Questionnaire (QLQ)-C30 + one sarcoma module; EORTC QLQ-C30 + one sarcoma module + an item list; EORTC QLQ-C30 + item list.
This will be based on analysis of the interview data (patients and HCPs) and the relevance of certain HRQoL rated by patients and health care professionals and possible identification of certain subgroups (according to tumour localization, type of sarcoma, disease stage and treatment).
Measured: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Secondary outcomes (3)
an exhaustive list of all HRQoL issues relevant to sarcoma patients
based on a literature review, analysis of interviews with patients and health care professionals we will create an exhaustive list of all HRQoL issues relevant to sarcoma patients.
Measured: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
the coverage of issues/items already available in the EORTC Item Library
the interview data and rating of HRQoL issues will be used to determine the overage of issues/ items in the EORTC Item Library and how the Item Library can be optimally used for the HRQoL measure for patients with sarcoma.
Measured: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
the proportion of patients in subgroups rating issues/items as relevant
In order to determine if issues are sarcoma-generic or dependent of sarcoma localization, sarcoma subtype, disease stage or treatment we will analyze the proportion of patients in each subgroup rating HRQoL issues or items as relevant
Measured: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 May 2019
- Primary completion30 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Leiden University Medical Center, Centre Leon Berard, University Hospital Carl Gustav Carus, Heidelberg University, Johannes Gutenberg University Mainz, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, National Cancer Institute, Naples, Maria Sklodowska-Curie National Research Institute of Oncology, Hospital San Carlos, Madrid, Royal Marsden NHS Foundation Trust, Beatson West of Scotland Cancer Centre, University Hospital Southampton NHS Foundation Trust, Royal National Orthopaedic Hospital NHS Trust, Bank of Cyprus Oncology Centre, Institut Català d'Oncologia, University of Adelaide, King Hussein Cancer Center, Oslo University Hospital, Erasmus Medical Center, University Medical Center Groningen, Centre Oscar Lambret, Aretaieio Hospital, Hospital Universitario Fundación Jiménez Díaz, The Christie NHS Foundation Trust, Ain Shams University, Prince of Wales Hospital, Shatin, Hong Kong, Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Olga Husson, PhD, Principal investigator, The Netherlands Cancer InstituteWinette van der Graaf, PhD, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071704
- Sponsor's protocol ID
- EORTC-1749
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2019
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
den Hollander D, Lidington E, Singer S, Sodergren SC, Salah S, Fiore M, Benson C, Desar IME, Burgers VWG, Husson O, van der Graaf WTA. 'I thought I had fibroids, and now I don't': a mixed method study on health-related quality of life in uterine sarcoma patients. Health Qual Life Outcomes. 2022 Apr 20;20(1):65. doi: 10.1186/s12955-022-01971-5.
PubMed 35443673den Hollander D, Fiore M, Martin-Broto J, Kasper B, Casado Herraez A, Kulis D, Nixon I, Sodergren SC, Eichler M, van Houdt WJ, Desar IME, Ray-Coquard I, Piccinin C, Kosela-Paterczyk H, Miah A, Hentschel L, Singer S, Wilson R, van der Graaf WTA, Husson O. Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol. Cancers (Basel). 2020 Dec 22;13(1):1. doi: 10.3390/cancers13010001.
PubMed 33561018
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
- ClinicalTrials.gov ID
- NCT04071704
- Acronym / sponsor ID
- EORTC-1749
- Conditions
- Sarcoma
- Keywords
- health-related quality of life, life satisfaction, treatment-related effects, quality of life measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Leiden University Medical Center, Centre Leon Berard, University Hospital Carl Gustav Carus, Heidelberg University, Johannes Gutenberg University Mainz, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, National Cancer Institute, Naples, Maria Sklodowska-Curie National Research Institute of Oncology, Hospital San Carlos, Madrid, Royal Marsden NHS Foundation Trust, Beatson West of Scotland Cancer Centre, University Hospital Southampton NHS Foundation Trust, Royal National Orthopaedic Hospital NHS Trust, Bank of Cyprus Oncology Centre, Institut Català d'Oncologia, University of Adelaide, King Hussein Cancer Center, Oslo University Hospital, Erasmus Medical Center, University Medical Center Groningen, Centre Oscar Lambret, Aretaieio Hospital, Hospital Universitario Fundación Jiménez Díaz, The Christie NHS Foundation Trust, Ain Shams University, Prince of Wales Hospital, Shatin, Hong Kong, Sheba Medical Center
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The investigators will follow the EORTC QLG questionnaire development guidelines. First, a computerized search of the academic literature will be performed to identify all relevant HRQoL issues for and existing HRQoL questionnaires currently used among patients with sarcoma. In parallel, semi-structured interviews will be conducted worldwide with patients with sarcoma(N=179) and health care professionals (HCPs; N=35; phase 1a). The patient sample will be stratified to capture diversity across the sarcoma population tumour location (extremities, axial, head and neck, thorax, retroperitoneal/intra-abdominal and gynecological), stage (localized vs. metastatic disease ) and type or lines of treatment .
This list of HRQoL issues generated by the a) literature search, b) relevant items from the Item Library, and c) semi-structured patient and HCP interviews, and will be consolidated into a comprehensive list of issues for all languages of collaborating countries.
In phase 1b, the new list of HRQoL issues will be presented to another group of patients with sarcoma(N=475) and HCPs (N=72). Patients and HCPs will be asked to rate the HRQoL issues on relevance (4point Likert scale) and to prioritize the 10 most important issues.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients who have been or are being treated for sarcoma. |
| Health care professionals | – | –Health care professionals with extensive experience in sarcoma care (medical oncologists, radiation oncologists, surgical oncologists, orthopaedic surgeons, nurse specialists, psychologists, physiotherapists) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sarcoma, with all stages of disease. The primary types of treatments to be included, depending on sarcoma subtype, are chemotherapy/targeted therapy, radiotherapy, surgery, or a combination of these.
Key inclusion criteria (2 listed)
- Age at diagnosis 18 years or older
- Having a confirmed diagnosis of sarcoma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
a framework for a HRQoL measure for patients with sarcoma
Time frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
the framework will outline which strategy to adopt for HRQoL in patients with sarcoma: the EORTC Quality of Life Questionnaire (QLQ)-C30 + one sarcoma module; EORTC QLQ-C30 + one sarcoma module + an item list; EORTC QLQ-C30 + item list. This will be based on analysis of the interview data (patients and HCPs) and the relevance of certain HRQoL rated by patients and health care professionals and possible identification of certain subgroups (according to tumour localization, type of sarcoma, disease stage and treatment).
3 secondary outcomes
an exhaustive list of all HRQoL issues relevant to sarcoma patients
Time frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
the coverage of issues/items already available in the EORTC Item Library
Time frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
the proportion of patients in subgroups rating issues/items as relevant
Time frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 35443673den Hollander D, Lidington E, Singer S, Sodergren SC, Salah S, Fiore M, Benson C, Desar IME, Burgers VWG, Husson O, van der Graaf WTA. 'I thought I had fibroids, and now I don't': a mixed method study on health-related quality of life in uterine sarcoma patients. Health Qual Life Outcomes. 2022 Apr 20;20(1):65. doi: 10.1186/s12955-022-01971-5.
- Derived from this study: PubMed 33561018den Hollander D, Fiore M, Martin-Broto J, Kasper B, Casado Herraez A, Kulis D, Nixon I, Sodergren SC, Eichler M, van Houdt WJ, Desar IME, Ray-Coquard I, Piccinin C, Kosela-Paterczyk H, Miah A, Hentschel L, Singer S, Wilson R, van der Graaf WTA, Husson O. Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol. Cancers (Basel). 2020 Dec 22;13(1):1. doi: 10.3390/cancers13010001.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Husson, PhD principal investigator
The Netherlands Cancer Institute
Winette van der Graaf, PhD, MD principal investigator
The Netherlands Cancer Institute
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by The Netherlands Cancer Institute at 3 sites in 2 countries.
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 2 inclusion and 4 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Jordan. 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?
a framework for a HRQoL measure for patients with sarcoma (time frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)). 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 NCT04071704, which also lists 2 linked publications.
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 22 Apr 2026.