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

EORTC Quality of Life Group and Breast Cancer Group

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)283-288
Number of pages6
JournalAnnals of Oncology
Volume31
Issue number2
DOIs
Publication statusPublished - Feb 2020

Fingerprint

Quality of Life
Organizations
Breast Neoplasms
Research
Neoplasms
Therapeutics
Psychometrics
Surveys and Questionnaires
Health Personnel
Patient Care
Mucous Membrane
Guidelines
Interviews
Skin

Keywords

  • breast cancer
  • module development
  • patient-reported outcome (PRO)
  • quality of life

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients : EORTC QLQ-BR45. / EORTC Quality of Life Group and Breast Cancer Group.

In: Annals of Oncology, Vol. 31, No. 2, 02.2020, p. 283-288.

Research output: Contribution to journalArticle

EORTC Quality of Life Group and Breast Cancer Group. / An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients : EORTC QLQ-BR45. In: Annals of Oncology. 2020 ; Vol. 31, No. 2. pp. 283-288.
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title = "An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45",
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",
author = "{EORTC Quality of Life Group and Breast Cancer Group} and V. Bjelic-Radisic and F. Cardoso and D. Cameron and E. Brain and K. Kuljanic and {da Costa}, {R. A.} and T. Conroy and Inwald, {E. C.} and S. Serpentini and M. Pinto and J. Weis and O. Morag and {Lindviksmoen Astrup}, G. and Tomaszweksi, {K. A.} and K. Pogoda and P. Sinai and M. Sprangers and N. Aaronson and G. Velikova and E. Greimel and J. Arraras and A. Bottomley and Eveline Bleiker and Brigitte Bliem and Weichu Chie and Carien Creutzberg and Valerie Deville and Francois Duhoux and Kirsten Eilf and Sue Hartup and Michael Koller and Eva Nagele and Ourania Nicolatou-Galitis and Anne Oberguggenberger and Claudia Schmalz and Zoe Winters",
year = "2020",
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language = "English",
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T1 - An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients

T2 - EORTC QLQ-BR45

AU - EORTC Quality of Life Group and Breast Cancer Group

AU - Bjelic-Radisic, V.

AU - Cardoso, F.

AU - Cameron, D.

AU - Brain, E.

AU - Kuljanic, K.

AU - da Costa, R. A.

AU - Conroy, T.

AU - Inwald, E. C.

AU - Serpentini, S.

AU - Pinto, M.

AU - Weis, J.

AU - Morag, O.

AU - Lindviksmoen Astrup, G.

AU - Tomaszweksi, K. A.

AU - Pogoda, K.

AU - Sinai, P.

AU - Sprangers, M.

AU - Aaronson, N.

AU - Velikova, G.

AU - Greimel, E.

AU - Arraras, J.

AU - Bottomley, A.

AU - Bleiker, Eveline

AU - Bliem, Brigitte

AU - Chie, Weichu

AU - Creutzberg, Carien

AU - Deville, Valerie

AU - Duhoux, Francois

AU - Eilf, Kirsten

AU - Hartup, Sue

AU - Koller, Michael

AU - Nagele, Eva

AU - Nicolatou-Galitis, Ourania

AU - Oberguggenberger, Anne

AU - Schmalz, Claudia

AU - Winters, Zoe

PY - 2020/2

Y1 - 2020/2

N2 - 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.

AB - 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.

KW - breast cancer

KW - module development

KW - patient-reported outcome (PRO)

KW - quality of life

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