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/study/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:
Condition category
Condition code

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

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Other
Name
The Netherlands Cancer Institute
Address
Country

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/study/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/study/NCT04071704