Clinical trial NCT02979678: European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) Breast Cancer Module Update
Official title: The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: Breast cancer, quality of life
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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 .

Eligibility criteria: Inclusion Criteria:

* Patients with early or metastatic breast cancer

Exclusion Criteria:

* Patients with second malignancy

Primary outcomes:
measure: Quality of life
timeFrame: 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Rijeka
country: Croatia
facility: University Hospital Centre Rijeka
city: Lorraine
country: France
facility: Institut de Cancerologie de Lorraine
city: Regensburg
country: Germany
facility: University Medical Center Regensburg
city: Naples
country: Italy
facility: Instituto Nazionale Tumori Fondazione Pascale
city: Padivarma
country: Italy
facility: IOV Oncologico Veneto Padova
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - NKI
city: Krakow
country: Poland
facility: Jagiellonian University Medical College Krakow
city: Navarra
country: Spain
facility: Oncology Department Hospital of Navarre
Study officials:
affiliation: Medical University of Graz
name: Vesna Bjelic-Radisic
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.
citation: Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011