JOURNAL ONKOLOGIE – STUDIE
Assessing Health-related Quality of Life in Sarcoma Patients
Rekrutierend
NCT-Nummer:
NCT04071704
Studienbeginn:
Mai 2019
Letztes Update:
28.08.2019
Wirkstoff:
-
Indikation (Clinical Trials):
Sarcoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
The Netherlands Cancer Institute, The Netherlands Cancer Institute
Collaborator:
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 d
Studienleiter
Principal Investigator
The Netherlands Cancer Institute
Principal Investigator
The Netherlands Cancer Institute
Kontakt
Kontakt:
Phone: +31650008401
E-Mail: D.denHollander@radboudumc.nl» Kontaktdaten anzeigen
Studienlocations
(3 von 7)
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Adelaide
AustraliaAbgeschlossen» Google-Maps
Nicosia
CyprusRekrutierend» Google-Maps
Amsterdam
NetherlandsRekrutierend» Google-Maps
Nijmegen
NetherlandsRekrutierend» Google-Maps
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome: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:
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
Studien-Arme
- 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)
Quelle: ClinicalTrials.gov
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