Sarcoma

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 compiled an exhaustive list of HRQoL issues relevant to sarcoma patients. In the process of compiling the list, three sources were consecutively consulted: (1) a systematic review of the literature/drug-related documentation, (2) patients interviews (n=179), and (3) health care professional (HCP) interviews (n = 35). During the interviews, patients and HCPs were also asked to review existing HRQoL questionnaires for topic and item relevance. The respondents were also asked to identify HRQoL issues that they believe to be important that are not included in the current core questionnaires.

In phase 1b, we presented the newly created list of HRQoL issues to another group of sarcoma patients (n=490) and health care professionals (n = 80) and asked them to rate the issues on relevance and to prioritize the most important issues. Patients were also asked to complete the EORTC QLQ-C30 and a supplementary site specific questionnaire about HRQoL issues. We are currently interpreting and formalizing the results from Phase 1B. The final results are expected after September 2025.

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.
Study contract is signed by institutions for start phase 1B.
36 sites were opened for recruitment of patients and/or HCPs in phase 1B.
One patient organization Dutch Contact group Sarcoma started to recruit patients.
Proposals for recruitment of patients according to simplified stratification matrix were prepared for all sites.
17 sites have oversampled patient inclusion at our request. The total numbers of patients according to the set goal was reached 490/475.
9 sites only participated with HCPs
The total number of HCPs needed according to stratification matrix was reached (80/72). Extra HCPs were recruited because of incomplete data.

Data was checked on inconsistencies and in case of inconsistencies, queries were send out to the sites.Preliminary results were discussed with collaborators.

Statistical analysis has been completed.

Current status:

Phase 1a (generation of HRQoL issues) completed;

Phase 1b (rating issues on relevance and importance) recruitment HCP completed and patient recruitment is  completed according to simplified stratification matrix for patients. Data is checked on inconsistencies and in case of inconsistencies, queries were send out to the sites.

We are currently analyzing and interpreting the results. The Phase 1 report is being written, and our goal is to finalize the first version before the QLG Autumn meeting.

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: 36 sites open. We started with recruitment of patients by two patient organizations.  A second round of recruitment will start (17 sites have included extra patients)

9 sites only participated with HCPs.

February/March 2024: end of recruitment of HCPs and start with statistical analyses.

September 2024: End of recruitment of patients and start with statistical analyses. In case of inconsistencies, queries will be send out to the sites.

March 2025: writing phase 1 report with recommendation on how to move forward with assessment of QoL in sarcoma patients.

April/May 2025: statistical analysis.

October/December 2025: Finalize the Phase 1 report with input from the QLG meeting and begin drafting the first manuscript on the main results for publication.

January/February 2026: Draft the second manuscript focusing on sub-analyses.

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.