ANZCTR - Registration

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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]

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?

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

Olga Husson, PhD

Address

The Netherlands Cancer Institute

Country

Phone

Fax

Contact person for public queries

Name

Tom Bootsma, MSc

Address

Country

Phone

+31205126993

Fax

t.bootsma@nki.nl

Contact person for scientific queries

No information has been provided regarding IPD availability

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

Trial Review

Registering a new trial?

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