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

Published:January 06, 2020DOI:https://doi.org/10.1016/j.annonc.2019.10.027

      Highlights

      • Update of the EORTC QLQ Breast Module.
      • It provides a more accurate and comprehensive assessment of the impact of current treatment modalities on patients' QoL.
      • The EORTC QLQ-BR45 is available for use in research and clinical practice.

      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.

      Key words

      To read this article in full you will need to make a payment
      Subscribe to Annals of Oncology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Jougla E.
        • Rossolin F.
        • Pavillon G.
        Cause of death statistics: production process, quality and international comparability (ENCR cancer fact sheets; Chapter 3).
        in: World Health Organisation. International Agency for Research on Cancer. Atlas of Cancer Mortality in the European Union and the European Economic Area 1993–1997. International Agency for Research on Cancer, Lyon, France2008: 9-15 (Available at)
      1. Perry N. Broeders M. deWolf C. European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis. 4th ed. Office for Official Publications of the European Communities, Luxembourg2006
        • World Health Organization
        Cancer mortality patterns by site (ENCR cancer fact sheets; Chapter 6).
        in: Atlas of Cancer Mortality in the European Union and the European Economic Area 1993-1997. International Agency for Research on Cancer, Lyon, France2008: 118 (Available at)
        • Cancer Research UK
        Cancer Incidence Statistics.
        (Available at)
        www.cancerresearchuj.org
        Date accessed: November 14, 2019
        • Sprangers M.A.G.
        • Groenvold M.
        • Arraras J.I.
        • et al.
        The European Organisation 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; 14: 2756-2768
        • Brady M.J.
        • Cella D.F.
        • Mo F.
        • et al.
        Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.
        J Clin Oncol. 1997; 15: 974-986
        • Nguyen J.
        • Popovic M.
        • Chow E.
        • et al.
        EORTC QLQ-BR23 and FACT-B for the assessment of quality of life in patients with breast cancer: a literature review.
        J Comp Eff Res. 2015; 4: 157-166
        • Marta G.N.
        • Moraes F.Y.
        • Leite E.T.T.
        • et al.
        A critical evaluation of quality of life in clinical trials of breast cancer patients treated with radiation therapy.
        Ann Palliat Med. 2017; 6: S223-S232
        • Gibson L.
        • Lawrence D.
        • Dawson C.
        • et al.
        Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women.
        Cochrane Database Syst. 2009; 7: CD 0031370
        • Perez E.A.
        Safety profiles of tamoxifen and the aromatase inhibitors in adjuvant therapy of hormone-responsive early breast cancer.
        Ann Oncol. 2007; 18: viii26-viii35
        • van Nes J.G.
        • Fontein D.B.
        • Hille E.T.
        • et al.
        Quality of life in relation to tamoxifen or exemestane treatment in postmenopausal breast cancer patients: a Tamoxifen Exemestane Adjuvant Multinational (TEAM) Trial side study.
        Breast Cancer Res Treat. 2012; 134: 267-276
        • Stockler M.
        • Wilcken N.R.
        • Ghersi D.
        • et al.
        Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer.
        Cancer Treat Rev. 2000; 26: 151-168
        • Alken S.
        • Kelly C.M.
        Benefit risk assessment and update on the use of docetaxel in the management of breast cancer.
        Cancer Manag Res. 2013; 14: 357-365
        • Ward S.
        • Simpson E.
        • Davis S.
        • et al.
        Taxanes for the adjuvant treatment of early breast cancer: systematic review and economic evaluation.
        Health Technol Assess. 2007; 11: 1-144
        • Gianno L.
        • Dafni U.
        • Gelber R.D.
        • et al.
        Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with Her2-positive early breast cancer: a 4-year follow-up of randomised controlled trial.
        Lancet Oncol. 2011; 12: 236-244
        • Harbeck N.
        • Iyer S.
        • Turner N.
        • et al.
        Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.
        Ann Oncol. 2016; 27: 1047-1054
        • Winters Z.E.
        • Afzal M.
        • Rutherford C.
        • et al.
        International validation of the European Organisation for Research and Treatment of Cancer QLQ-BRECON23 quality-of-life questionnaire for women undergoing breast reconstruction.
        Br J Surg. 2018; 105: 209-222
        • Johnson C.D.
        • Aaronson N.K.
        • Blazeby J.M.
        • et al.
        Guidelines for Developing Questionnaires Modules.
        4th edn. European Organization for Research and Treatment of Cancer, Brussels, Belgium2011
        • Sodergren S.C.
        • Copson E.
        • White A.
        • et al.
        Systematic review of the side effects associated with anti-HER2-targeted therapies used in the treatment of breast cancer, on behalf of the EORTC Quality of Life Group.
        Target Oncol. 2016; 11: 277-292
        • Winters Z.E.
        • Afzal M.
        • Rutherford C.
        • et al.
        International validation of the European Organisation for Research and Treatment of Cancer QLQ-BRECON23 quality-of-life questionnaire for women undergoing breast reconstruction.
        Br J Surg. 2018; 105: 209-222
        • Delbecq A.L.
        • Van deVen A.H.
        • Gustafson D.H.
        Group Techniques for Program Planning: A Guide to Nominal Group and Delphi Processes.
        Green Briar Press, Middleton, WI1986
        • Kulis D.
        • Whittaker C.
        • Martinelli F.
        • et al.
        23rd Annual Conference of the International Society for Quality: introducing the new EORTC Quality of Life Group item bank.
        Qual Life Res. 2016; 25: 76-77
        • Kuliś D.
        • Bottomley A.
        • Velikova G.
        • et al.
        EORTC Quality of Life Group Translation Procedure.
        4th ed. European Organization for Research and Treatment of Cancer, Brussels, Belgium2016

      Linked Article