An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45

V Bjelic-Radisic; F Cardoso; D Cameron; E Brain; K Kuljanic; R A da Costa; T Conroy; E C Inwald; S Serpentini; M Pinto; J Weis; O Morag; G Lindviksmoen Astrup; K A Tomaszweksi; K Pogoda; P Sinai; M Sprangers; N Aaronson; G Velikova; E Greimel; J Arraras; A Bottomley; EORTC Quality of Life Group and Breast Cancer Group

doi:10.1016/j.annonc.2019.10.027

An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45

Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18.

Authors

V Bjelic-Radisic¹, F Cardoso², D Cameron³, E Brain⁴, K Kuljanic⁵, R A da Costa⁶, T Conroy⁷, E C Inwald⁸, S Serpentini⁹, M Pinto¹⁰, J Weis¹¹, O Morag¹², G Lindviksmoen Astrup¹³, K A Tomaszweksi¹⁴, K Pogoda¹⁵, P Sinai¹⁶, M Sprangers¹⁷, N Aaronson¹⁸, G Velikova¹⁹, E Greimel²⁰, J Arraras²¹, A Bottomley²²; EORTC Quality of Life Group and Breast Cancer Group

Collaborators

EORTC Quality of Life Group and Breast Cancer Group:
Eveline Bleiker, Brigitte Bliem, Weichu Chie, Carien Creutzberg, Valerie Deville, Francois Duhoux, Kirsten Eilf, Sue Hartup, Michael Koller, Eva Nagele, Ourania Nicolatou-Galitis, Anne Oberguggenberger, Claudia Schmalz, Zoe Winters

Affiliations

¹ Breast Unit, Helios University Clinic, University Witten/Herdecke, Wuppertal, Germany. Electronic address: [email protected].
² Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.
³ Cancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UK.
⁴ Department of Medical Oncology Institute Curie - Hôpital René Huguenin, Saint-Cloud, France.
⁵ Department of Obstetrics and Gynecology, Clinical Center Rijeka, Rijeka, Croatia.
⁶ Department of Mastology and Breast Reconstruction, Barretos Cancer Hospital, Barretos, Brazil.
⁷ Department of Medical Oncology, Lorraine Cancer Institute, Vandoeuvre-lès-Nancy, France.
⁸ Department of Gynecology and Obstetrics, University Medical Center Regensburg, Regensburg, Germany.
⁹ Unit for Psychooncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
¹⁰ National Tumor Institute, Instituto Nazionale Tumori Fondazione Pascale Naples, Naples, Italy.
¹¹ Comprehensive Cancer Center, Medical Faculty, University Medical Center Freiburg, Freiburg, Germany.
¹² Unit Pain Clinic, Sheba - Tel Ha Shomer Hospital, Tel Aviv, Israel.
¹³ Department of Oncology, Oslo University Hospital, Oslo, Norway.
¹⁴ Department of Surgery, Jagillonian University Medical College Krakow, Krakow, Poland.
¹⁵ Department of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.
¹⁶ Southmead Hospital, University of Bristol, Bristol, UK.
¹⁷ Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
¹⁸ Department of Psychosocial Research, NKI Netherlands, Amsterdam, The Netherlands.
¹⁹ Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.
²⁰ Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.
²¹ Oncology Department, Hospital of Navarre, Pamplona, Spain.
²² EORTC HQ, Quality of Life Department, Brussels, Belgium.

PMID: 31959345
DOI: 10.1016/j.annonc.2019.10.027

Abstract

Background: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires 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 an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire.

Patients and methods: The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items.

Results: The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale.

Conclusion: Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

Keywords: breast cancer; module development; patient-reported outcome (PRO); quality of life.

Publication types

Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Breast Neoplasms* / drug therapy
Clinical Trials as Topic
Humans
Psychometrics
Quality of Life*
Reproducibility of Results
Surveys and Questionnaires