European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) Breast Cancer Module Update

Quality of Life Clinical Trial

Official title:

The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979678
• Other study ID #: 27-355
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: September 5, 2017
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: September 2017
• Source: Medical University of Graz
• Contact: Vesna Bjelic-Radisic
• Phone: +43 316 385 80504
• Email: vesna.bjelic-radisic[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the development of BR-23 published 1996 the standard therapy of breast cancer has changed. New therapies brought new side effects and different impact on QoL (quality of life) are not sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both from clinical and scientific point of view.

Description:

1. Based on a systematic literature search a new issue list will be developed, containing additional issues relevant for new treatment strategies. A total of 5-10 patients from different countries (5-8) as well as health care professionals (5/country) will be interviewed (Phase 1).

2. Operationalization of the issues into items; a provisional version of a the questionnaire and a hypothetic scale structure will be established (Phase2).

3. The resulting provisional updated module will be tested with respect to understanding, comprehensiveness and applicability (according to the EORTC Module Development Guidelines). The items will be translated from English into other languages following a standardized forward-backward procedure. Total aof 260 patients will be interviewed from different cultural areas: Northern Europe, Central Europe, Southern Europe, Asia (Phase 3).

4. The module and its scale structure will be field-tested in a large, international group of patients in order to determine its acceptability, reliability, validity, responsiveness and crosscultural applicability .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: June 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with early or metastatic breast cancer

Exclusion Criteria:

• Patients with second malignancy

Related Conditions & MeSH terms

• Breast Neoplasms
• Quality of Life

Intervention

Other:
• Questionnaire
The questionnaire should be updated with respect to wording, terminology.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Croatia	University Hospital Centre Rijeka	Rijeka
France	Institut de Cancerologie de Lorraine	Lorraine
Germany	University Medical Center Regensburg	Regensburg
Italy	Instituto Nazionale Tumori Fondazione Pascale	Naples
Italy	IOV Oncologico Veneto Padova	Padivarma
Netherlands	Netherlands Cancer Institute - NKI	Amsterdam
Poland	Jagiellonian University Medical College Krakow	Krakow
Spain	Oncology Department Hospital of Navarre	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Countries where clinical trial is conducted

Austria,  Croatia,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain, 

References & Publications (2)

Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011

Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnair — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Patients under Treatment are asked to complete the questionnaire	3 years, Patients under treatment are asked once to complete the questionnaire during 3 years