Assessing Health-related Quality of Life in Sarcoma Patients

NCT04071704 | Completed

• 1 other identifier: EORTC-1749
• Study Type: observational
• Target: 654
• Locations: 2 countries
• Sites: 3

Brief 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. 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?

Conditions

Sarcoma

Keywords

health-related quality of life; life satisfaction; treatment-related effects; quality of life measure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)

• the proportion of patients in subgroups rating issues/items as relevant

  1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

University Hospital Carl Gustav Carus

Dresden, Germany

Location

Johannes Gutenberg University Mainz

Mainz, Germany

Location

Kiing Hussein Cancer Centre

Amman, Jordan

Location

Related Publications (2)

• 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.

  PMID: 35443673 DERIVED

• 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.

  PMID: 33561018 DERIVED

MeSH Terms

Conditions

Sarcoma; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Behavior

Study Officials

• Olga Husson, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

• Winette van der Graaf, PhD, MD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 28, 2019
• Study Start: May 1, 2019
• Primary Completion: August 30, 2024
• Study Completion: September 1, 2024
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); JO (1)