Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Olga Husson
Netherlands Cancer Institute & RMH/ICR
London, United Kingdom
, Winette van der Graaf
Netherlands Cancer Institute, Amsterdam & , Erasmus Medical Center, Rotterdam
Amsterdam, Netherlands

Project summary

Although sarcoma patients have higher survival rates with different treatments, they often experience side-effects and psychosocial issues that negatively impact health-related quality of life(HRQoL) during and long after treatment. Therefore, it is important to assess treatment  effectiveness in terms of subjective patient reported outcomes including HRQoL as well. Generic HRQoL instruments are available, but questionnaires capturing all of the unique experiences of sarcoma patients are currently lacking. To be able to develop a HRQoL instrument specifically for sarcoma-patients, this study aims to provide insight into the relevant HRQoL issues in this patient-group. Furthermore, we will investigate how to design the questionnaires.

In the first phase of this study, phase 1a, we will compile an exhaustive list of HRQoL issues relevant to sarcoma patients in phase 1a. In the process of compiling the list, three sources will consecutively consulted: (1) a systematic review of the literature/drug-related documentation, (2) patients (N=154) and (3) health care professionals (N=30). During the interviews, patients and HCPs will also be asked to review existing HRQoL questionnaires for topic and item relevance. The respondents will also be asked to identify HRQoL issues that they believe to be important that are not included in the current core questionnaires.

In phase 1b, we will present the newly created list of HRQoL issues to another group of sarcoma patients (N=475) and health care professionals (N=30) and ask them to rate the issues on relevance and to prioritize the most important issues. Patients are also asked to complete the EORTC QLQ-C30 and a supplementary site specific questionnaire about HRQoL issues.


Preparation of start phase 1b:
The issue list is translated by collaborators.
Approval of start phase 1B is obtained at institutions of collaborators in different countries (ongoing for some (new sites)).
Study contract is signed by institutions for start phase 1B (except France-Lille).
The issue list and EORTC questionnaires are programmed in CASTOR EDC for start data collection in phase 1B.
CASTOR was tested by different collaborators and instructions for use of CASTOR were developed.
Instructions were added to all paper-based questionnaires in different languages.
20 sites were opened or will be opened in September/October for recruitment of patients and HCPs in phase 1B.
Proposals for recruitment of patients according to stratification matrix were prepared for all sites.
We invited 5 new sites.
We started a second round of recruitment (1 site and more will follow).

Future plans

May 2021- April 2022: second round of patient and HCP interviews (phase 1a) The preparations of phase 1B started in May 2021. Since August 2021 recruitment of phase 1B is open: 4 sites started. We plan to open recruitment of phase 1B at all sites in April 2022.

March 2023: statistical analyses and writing phase 1 report with recommendation on how to move forward with assessment of QoL in sarcoma patients.



If you are interested to collaborate in phase 1b and help recruiting patients with sarcoma, please contact Olga Husson:

For patients

Symptoms and side effects of sarcoma and its treatment(s) may have an impact on a patient’s well-being. However, there is currently no way to measure quality of life specifically in sarcoma patients. We would like to find out how the diagnosis with a sarcoma has affected patients physically, socially and emotionally in order to develop a questionnaire about quality of life and symptom burden for sarcoma patients. This questionnaire will allow future research to understand the patient’s perspective on how the disease and treatments affect their lives. We aim to recruit approximately 630 patients internationally and conduct interviews and ask patients to complete and rate questionnaires.


Conference abstract:
1) CTOS 2019: Poster presentation: trial design


1) den Hollander D, Van der Graaf WTA, Fiore M, Kasper B, Singer S, Desar IME, Husson O. Unravelling the heterogeneity of soft tissue and bone sarcoma patients’ health-related quality of life: a systematic literature review with focus on tumour location. ESMO Open. 2020; 5(5):e000914
2) den 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. 2020; 13(1):1. doi: 10.3390/cancers13010001
3) van Eck I, den Hollander D, Lidington E, Hentschel L, Eichler M, Salah S, Singer S, Pinto M, Fauske L, Fiore M, Nixon I, Constantinidou A, Desar IME, Bonenkamp JJ, van Houdt WJ, Reuvers MJP, Haas RLM, Bruland ØS, Kasper B, van der Graaf WTA, Husson O. Health-Related Quality of Life Issues Experienced by Thoracic and Breast Sarcoma Patients: A Rare and Understudied Group, J Clin Med. 2021 Nov 16;10(22):5334. doi: 10.3390/jcm10225334.
4)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.