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
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 .
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