Clinical trial NCT04071704: Assessing Health-related Quality of Life in Sarcoma Patients
Official title: Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoma
Keywords: health-related quality of life
life satisfaction
treatment-related effects
quality of life measure
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Leiden University Medical Center
name: Centre Leon Berard
name: University Hospital Carl Gustav Carus
name: Heidelberg University
name: Johannes Gutenberg University Mainz
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: National Cancer Institute, Naples
name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Hospital San Carlos, Madrid
name: Royal Marsden NHS Foundation Trust
name: Beatson West of Scotland Cancer Centre
name: University Hospital Southampton NHS Foundation Trust
name: Royal National Orthopaedic Hospital NHS Trust
name: Bank of Cyprus Oncology Centre
name: Institut Català d'Oncologia
name: University of Adelaide
name: King Hussein Cancer Center
name: Oslo University Hospital
name: Erasmus Medical Center
name: University Medical Center Groningen
name: Centre Oscar Lambret
name: Aretaieio Hospital
name: Hospital Universitario Fundación Jiménez Díaz
name: The Christie NHS Foundation Trust
name: Ain Shams University
name: Prince of Wales Hospital, Shatin, Hong Kong
name: Sheba Medical Center
First posted: 2019-08-28
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: a framework for a HRQoL measure for patients with sarcoma
timeFrame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Secondary outcomes:
measure: an exhaustive list of all HRQoL issues relevant to sarcoma patients
timeFrame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
measure: the coverage of issues/items already available in the EORTC Item Library
timeFrame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
measure: the proportion of patients in subgroups rating issues/items as relevant
timeFrame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Mainz
country: Germany
facility: Johannes Gutenberg University Mainz
city: Amman
country: Jordan
facility: Kiing Hussein Cancer Centre
Study officials:
affiliation: The Netherlands Cancer Institute
name: Olga Husson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Cancer Institute
name: Winette van der Graaf, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.