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Assessing Health-related Quality of Life in Sarcoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071704
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Radboud University
Leiden University Medical Center
MOUNT SINAI HOSPITAL
Centre Leon Berard
University Hospital Carl Gustav Carus
Heidelberg University
Johannes Gutenberg University Mainz
Hippocration General Hospital
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
National Cancer Institute, Naples
Maria Sklodowska-Curie Institute - Oncology Center
Hospital San Carlos, Madrid
Hospitales Universitarios Virgen del Rocío
Royal Marsden NHS Foundation Trust
Beatson West of Scotland Cancer Centre
University Hospital Southampton NHS Foundation Trust
Royal National Orthopaedic Hospital NHS Trust
University College London Hospitals
Bank of Cyprus Oncology Centre
Institut Català d'Oncologia
University of Adelaide
King Hussein Cancer Center
Oslo University Hospital
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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?


Condition or disease
Sarcoma

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=154) and health care professionals (HCPs; N=30; 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=30). Patients and HCPs will be asked to rate the HRQoL issues on relevance (4point Likert scale) and to prioritize the 25 most important issues.

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Study Type : Observational
Estimated Enrollment : 689 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. an exhaustive list of all HRQoL issues relevant to sarcoma patients [ Time Frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines) ]
    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.

  2. the coverage of issues/items already available in the EORTC Item Library [ Time Frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines) ]
    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.

  3. the proportion of patients in subgroups rating issues/items as relevant [ Time Frame: 1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 who are too ill (death is imminent), as determined by the referring health care professional, will be excluded.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071704


Contacts
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Contact: Dide den Hollander, MSc, MD +31650008401 D.denHollander@radboudumc.nl

Locations
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Australia
University of Adelaide Completed
Adelaide, Australia
Cyprus
Bank of Cyprus Oncology Center Recruiting
Nicosia, Cyprus
Germany
University Hospital Carl Gustav Carus Recruiting
Dresden, Germany
Johannes Gutenberg University Mainz Recruiting
Mainz, Germany
University of Heidelberg Recruiting
Mannheim, Germany
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Netherlands
Sponsors and Collaborators
The Netherlands Cancer Institute
Radboud University
Leiden University Medical Center
MOUNT SINAI HOSPITAL
Centre Leon Berard
University Hospital Carl Gustav Carus
Heidelberg University
Johannes Gutenberg University Mainz
Hippocration General Hospital
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
National Cancer Institute, Naples
Maria Sklodowska-Curie Institute - Oncology Center
Hospital San Carlos, Madrid
Hospitales Universitarios Virgen del Rocío
Royal Marsden NHS Foundation Trust
Beatson West of Scotland Cancer Centre
University Hospital Southampton NHS Foundation Trust
Royal National Orthopaedic Hospital NHS Trust
University College London Hospitals
Bank of Cyprus Oncology Centre
Institut Català d'Oncologia
University of Adelaide
King Hussein Cancer Center
Oslo University Hospital
Investigators
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Principal Investigator: Olga Husson, PhD The Netherlands Cancer Institute
Principal Investigator: Winette van der Graaf, PhD, MD The Netherlands Cancer Institute
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04071704    
Other Study ID Numbers: EORTC-1749
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
health-related quality of life
life satisfaction
treatment-related effects
quality of life measure
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms