Assessing Health-related Quality of Life in Sarcoma Patients
NCT ID: NCT04071704
Last Updated: 2022-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
689 participants
OBSERVATIONAL
2019-05-01
2023-03-31
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients
Patients who have been or are being treated for sarcoma.
No interventions assigned to this group
Health care professionals
Health care professionals with extensive experience in sarcoma care (medical oncologists, radiation oncologists, surgical oncologists, orthopaedic surgeons, nurse specialists, psychologists, physiotherapists)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Having a confirmed diagnosis of sarcoma
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Leiden University Medical Center
OTHER
Centre Leon Berard
OTHER
University Hospital Carl Gustav Carus
OTHER
Heidelberg University
OTHER
Johannes Gutenberg University Mainz
OTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
National Cancer Institute, Naples
OTHER
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Hospital San Carlos, Madrid
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Beatson West of Scotland Cancer Centre
UNKNOWN
University Hospital Southampton NHS Foundation Trust
OTHER
Royal National Orthopaedic Hospital NHS Trust
OTHER
Bank of Cyprus Oncology Centre
OTHER
Institut Català d'Oncologia
OTHER
University of Adelaide
OTHER
King Hussein Cancer Center
OTHER
Oslo University Hospital
OTHER
Erasmus Medical Center
OTHER
University Medical Center Groningen
OTHER
Centre Oscar Lambret
OTHER
Aretaieio Hospital
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
The Christie NHS Foundation Trust
OTHER
Ain Shams University
OTHER
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Sheba Medical Center
OTHER_GOV
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Olga Husson, PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Winette van der Graaf, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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University Hospital Carl Gustav Carus
Dresden, , Germany
Johannes Gutenberg University Mainz
Mainz, , Germany
Kiing Hussein Cancer Centre
Amman, , Jordan
Countries
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Central Contacts
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References
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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.
Other Identifiers
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EORTC-1749
Identifier Type: -
Identifier Source: org_study_id
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