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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04071704




Registration number
NCT04071704
Ethics application status
Date submitted
8/08/2019
Date registered
28/08/2019

Titles & IDs
Public title
Assessing Health-related Quality of Life in Sarcoma Patients
Scientific title
Incorporating the Patient Voice in Sarcoma Research: How Can we Assess Health-related Quality of Life in This Heterogeneous Group of Patients?
Secondary ID [1] 0 0
EORTC-1749
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
a framework for a HRQoL measure for patients with sarcoma
Timepoint [1] 0 0
1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Secondary outcome [1] 0 0
an exhaustive list of all HRQoL issues relevant to sarcoma patients
Timepoint [1] 0 0
1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Secondary outcome [2] 0 0
the coverage of issues/items already available in the EORTC Item Library
Timepoint [2] 0 0
1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)
Secondary outcome [3] 0 0
the proportion of patients in subgroups rating issues/items as relevant
Timepoint [3] 0 0
1 week (and for several issues 4 weeks according to EORTC questionnaire guidelines)

Eligibility
Key inclusion criteria
* Age at diagnosis 18 years or older
* Having a confirmed diagnosis of sarcoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
689
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Dresden
Country [2] 0 0
Germany
State/province [2] 0 0
Mainz
Country [3] 0 0
Jordan
State/province [3] 0 0
Amman

Funding & Sponsors
Primary sponsor type
Other
Name
The Netherlands Cancer Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Radboud University Medical Center
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Leiden University Medical Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centre Leon Berard
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospital Carl Gustav Carus
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Heidelberg University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Johannes Gutenberg University Mainz
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
National Cancer Institute, Naples
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Maria Sklodowska-Curie National Research Institute of Oncology
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Hospital San Carlos, Madrid
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Royal Marsden NHS Foundation Trust
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Beatson West of Scotland Cancer Centre
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
University Hospital Southampton NHS Foundation Trust
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Royal National Orthopaedic Hospital NHS Trust
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Bank of Cyprus Oncology Centre
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Institut Català d'Oncologia
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
University of Adelaide
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
King Hussein Cancer Center
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Oslo University Hospital
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Erasmus Medical Center
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
University Medical Center Groningen
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
Centre Oscar Lambret
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
Aretaieio Hospital
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
Hospital Universitario Fundación Jiménez Díaz
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
The Christie NHS Foundation Trust
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
Ain Shams University
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Other
Name [27] 0 0
Prince of Wales Hospital, Shatin, Hong Kong
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Government body
Name [28] 0 0
Sheba Medical Center
Address [28] 0 0
Country [28] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Olga Husson, PhD
Address 0 0
The Netherlands Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tom Bootsma, MSc
Address 0 0
Country 0 0
Phone 0 0
+31205126993
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04071704