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 the process of compiling the list, three sources will be consecutively consulted: (1) a systematic review of the literature/drug-related documentation, (2) patients (N=179) and (3) health care professionals (N=35). 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=80) 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.
Achievements
Phase 1a (generation of HRQoL issues) completed.
Phase 1b (rating issues on relevance and importance)
- Recruitment of HCPs completed (from 9 sites). The total number of HCPs needed according to stratification matrix was reached (80/72). Extra HCPs were recruited because of incomplete data
- Patient recruitment is completed according to a simplified stratification matrix for patients. The total number of patients according to the set goal was reached 475/475
- Data will be checked for inconsistencies and in case of inconsistencies, queries will be sent out to the sites
Future plans
September 2024: Expected end of recruitment of patients and start with statistical analyses.
March 2025: writing phase 1 report with recommendation on how to move forward with assessment of QoL in sarcoma patients.
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.
Publications
Conference abstract:
1) CTOS 2019: Poster presentation: trial design
Publication:
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.