JOURNAL ONKOLOGIE – STUDIE

Assessing Health-related Quality of Life in Sarcoma Patients

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT04071704

Studienbeginn:
Mai 2019

Letztes Update:
06.01.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
The Netherlands Cancer Institute

Collaborator:
Radboud University Medical Center, Leiden University Medical Center, Centre Leon Berard, University Hospital Carl Gustav Carus, Heidelberg University, Johannes Gutenberg University Mainz, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, National Cancer In

Studienleiter

Olga Husson, PhD
Principal Investigator
The Netherlands Cancer Institute

Winette van der Graaf, PhD, MD
Principal Investigator
The Netherlands Cancer Institute

Kontakt

Tom Bootsma, MSc
Kontakt:
Phone: +31205126993
E-Mail: t.bootsma@nki.nl» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

University Hospital Carl Gustav Carus
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps

Johannes Gutenberg University Mainz
Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps

Kiing Hussein Cancer Centre
Amman
JordanRekrutierend» 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=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.

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 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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