Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 654
- Locations
- 3
- Primary Endpoint
- a framework for a HRQoL measure for patients with sarcoma
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Outcomes
Primary Outcomes
a framework for a HRQoL measure for patients with sarcoma
Time Frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
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).
Secondary Outcomes
- 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))
- 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 proportion of patients in subgroups rating issues/items as relevant(1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines))