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?

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?

Study Overview

• Status: Completed
• Conditions: Sarcoma

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 Type: Observational
• Enrollment (Actual): 654

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • University Hospital Carl Gustav Carus
  • Mainz, Germany
    • Johannes Gutenberg University Mainz
• Jordan
  • Amman, Jordan
    • Kiing Hussein Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Age at diagnosis 18 years or older
• Having a confirmed diagnosis of sarcoma

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Centre Leon Berard; Radboud University Medical Center; Royal Marsden NHS Foundation Trust; Oslo University Hospital; University Medical Center Groningen; Ain Shams University; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Erasmus Medical Center; Institut Català d'Oncologia; Heidelberg University; Sheba Medical Center; University of Adelaide; University Hospital Southampton NHS Foundation Trust; Johannes Gutenberg University Mainz; Prince of Wales Hospital, Shatin, Hong Kong; Leiden University Medical Center; National Cancer Institute, Naples; The Christie NHS Foundation Trust; Centre Oscar Lambret; Royal National Orthopaedic Hospital NHS Trust; Hospital Universitario Fundación Jiménez Díaz; Hospital San Carlos, Madrid; King Hussein Cancer Center; Maria Sklodowska-Curie National Research Institute of Oncology; Aretaieio Hospital; University Hospital Carl Gustav Carus; Beatson West of Scotland Cancer Centre; Bank of Cyprus Oncology Centre
• Investigators: Principal Investigator: Olga Husson, PhD, The Netherlands Cancer Institute; Principal Investigator: Winette van der Graaf, PhD, MD, The Netherlands Cancer Institute

Publications and helpful links

General 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.
• 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 (Basel). 2020 Dec 22;13(1):1. doi: 10.3390/cancers13010001.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: health-related quality of life; life satisfaction; treatment-related effects; quality of life measure
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Behavior; Sarcoma; Personal Satisfaction
• Other Study ID Numbers: EORTC-1749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No