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.
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 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
260
The questionnaire should be updated with respect to wording, terminology.
Medical University Graz
Graz, Austria
RECRUITINGUniversity Hospital Centre Rijeka
Rijeka, Croatia
RECRUITINGInstitut de Cancerologie de Lorraine
Lorraine, France
Quality of life
Patients under Treatment are asked to complete the questionnaire
Time frame: 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Medical Center Regensburg
Regensburg, Germany
RECRUITINGInstituto Nazionale Tumori Fondazione Pascale
Naples, Italy
RECRUITINGIOV Oncologico Veneto Padova
Padivarma, Italy
RECRUITINGNetherlands Cancer Institute - NKI
Amsterdam, Netherlands
RECRUITINGJagiellonian University Medical College Krakow
Krakow, Poland
RECRUITINGOncology Department Hospital of Navarre
Navarra, Spain
RECRUITING