Assessing Health-related Quality of Life in Sarcoma Patients

Sarcoma Clinical Trial

Official title:

Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071704
• Other study ID #: EORTC-1749
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2021
• Source: The Netherlands Cancer Institute
• Contact: Tom Bootsma, MSc
• Phone: +31205126993
• Email: t.bootsma[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 689
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus	Dresden
Germany	Johannes Gutenberg University Mainz	Mainz
Jordan	Kiing Hussein Cancer Centre	Amman

Sponsors (29)

Lead Sponsor

Collaborator

The Netherlands Cancer Institute

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

Countries where clinical trial is conducted

Germany,  Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)