The EORTC QLQ-BR23 was one of the first disease specific questionnaire developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996, major changes in BC treatment have occurred, requiring updating of the EORTC BC module. This abstract presents the phase I-III study updating the EORTC QLQ-BR23.
The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. QoL issues relevant for BC patients were generated in the phase I-II. Results of an extensive literature systematic review found 83 potential relevant QoL issues. After shortening the issues lists for overlapping, already existing in QLQ-C30 and QLQ BR-23 and following by interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module of 27 items was pre-tested to identify and solve potential problems with wording. The phase III part of development included administering the QLQ-C30 and the preliminary module to the target population to focus on evaluating the importance and the acceptability of the items. Qualitative and quantitative analyses were undertaken. In addition, we analysed the preliminary psychometric structure of the new items.
Phases I and II results indicated the need to supplement the original QLQ-BC 23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients from 12 countries. After the qualitative and quantitative analyses, the final updated Phase III module contains a total of 45 items, 23 items from the BR 23 and 22 new items. The new items contain two multi-item scales: target symptom scale (20 items) and satisfaction scale (2 items). The target symptom scale can be further divided in 3 subscales: endocrine therapy scale, endocrine sexual scale and skin/mucosa scale.
Our work has led to the development of a new EORTC BC module that builds on the EORTC QLQ-BR23. It includes 45 questions and provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients QoL. The final phase IV study is currently underway to confirm psychometric properties of the module.
Clinical trial identification
Legal entity responsible for the study
EORTC Quality of Life Group and Breast Cancer Group.
All authors have declared no conflicts of interest.