Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04071704




Registration number
NCT04071704
Ethics application status
Date submitted
8/08/2019
Date registered
28/08/2019
Date last updated
6/01/2022

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
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Other
Name [28] 0 0
Sheba Medical Center
Address [28] 0 0
Country [28] 0 0

Ethics approval
Ethics application status

Summary
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?
Trial website
https://clinicaltrials.gov/ct2/show/NCT04071704
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04071704