Breast (Apr 2025)
An international Phase IV field study - psychometric properties of the updated module on assessing quality of life of patients with breast cancer EORTC QLQ-BR42
- Vesna Bjelic-Radisic,
- Fatima Cardoso,
- Joachim Weis,
- Katarzyna Pogoda,
- Juan Ignacio Arraras,
- Elfriede Greimel,
- Andrew Bottomley,
- David Cameron,
- Etienne Brain,
- Sue Hartup,
- René Aloisio da Costa Vieira,
- Nicolette Hoefnagels,
- Chi-Cheng Huang,
- Omar Shamieh,
- Monica Pinto,
- Yared Belete Belay,
- Samantha Serpentini,
- Eveline Bleiker,
- Manjunath Nookala Krishnamurthy,
- Akihiko Shimomura,
- Elisabeth C. Sturm-Inwald,
- Mikiyas Amare Getu,
- Brigitte Bliem,
- Guro Astrup,
- Ofir Morag,
- Yuichiro Kikawa,
- Karin Kuljanic,
- Nora Nevries,
- Mirjam Sprangers,
- Neil K. Aaronson,
- Parisa Sinai,
- Krzysztof Tomaszewski,
- Razvan Galalae,
- Thierry Conroy,
- Francois Duhoux,
- Wei-chu Chie,
- Galina Velikova
Affiliations
- Vesna Bjelic-Radisic
- Breast Unit, Helios University Clinic Wuppertal, Germany; Corresponding author. Department of Gynecology, Helios University Clinic Wuppertal, University Witten/Herdecke, Breast Unit, Heusnerstrasse 40, Wuppertal, 42283, Germany.
- Fatima Cardoso
- Breast Unit Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, Portugal
- Joachim Weis
- Comprehensive Cancer Center, Medical Faculty, University Medical Center Freiburg, Freiburg, Germany
- Katarzyna Pogoda
- Department of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
- Juan Ignacio Arraras
- Department of Oncology, University Hospital of Navarre, Pamplona, Spain
- Elfriede Greimel
- Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria
- Andrew Bottomley
- EORTC HQ, Quality of Life Department, Brussels, Belgium
- David Cameron
- Cancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UK
- Etienne Brain
- Department of Medical Oncology, Institut Curie, Saint-Cloud, France
- Sue Hartup
- Breast Unit, Helios University Clinic Wuppertal, Germany; Breast Unit Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, Portugal; Comprehensive Cancer Center, Medical Faculty, University Medical Center Freiburg, Freiburg, Germany; Department of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Department of Oncology, University Hospital of Navarre, Pamplona, Spain; Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria; EORTC HQ, Quality of Life Department, Brussels, Belgium; Cancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UK; Department of Medical Oncology, Institut Curie, Saint-Cloud, France; Leeds Institute of Medical Research, University of Leeds, Leeds, UK; Department of Mastology and Breast Reconstruction, Barretos Cancer Hospital, Barretos, Brazil; Tumor- and Breast Center of Eastern Switzerland, (TBZO, St. Gallen site), Switzerland; Taipei Veterans General Hospital, Comprehensive Breast Health Center and Division of Breast Surgery, Taipei, Taiwan; National Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, Taiwan; King Hussein Cancer Center, Department of Palliative Medicine, Amman, Jordan; Istituto Nazionale Tumori – IRCCS – Fondazione G. Pascale, Naples, Italy; Mekelle University, School of Pharmacy, Mekelle, Ethiopia; School of Public Health and Preventive Medicine, Monash University, VIC, Australia; Unit for Psychooncology, Veneto Institute of Oncology IOV e IRCCS, Padua, Italy; Netherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the Netherlands; Dept. of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India; Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan; Department of Gynecology and Obstetrics, University Medical Center Regensburg, Regensburg, Germany; Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia; Department of Oncology, Oslo University Hospital, Oslo, Norway; Cancer Pain Service, Chaim Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel; Kansai Medical University, Dept. of Breast Surgery, Osaka, Japan; Department of Obstetrics and Gynecology, Clinical Center Rijeka, Rijeka, Croatia; Netherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the Netherlands; Southmead Hospital, University of Bristol, Bristol, UK; Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland; MedAustron, Neustadt, Austria; Département d’oncologie médicale, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France; Department of Medical Oncology, Institut Roi Albert II, Cliniques universitaires Saint-Luc (UCLouvain), Brussels, Belgium; Leeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UK; Leeds Cancer Centre, St James’s University Hospital, Leeds, UK
- René Aloisio da Costa Vieira
- Department of Mastology and Breast Reconstruction, Barretos Cancer Hospital, Barretos, Brazil
- Nicolette Hoefnagels
- Tumor- and Breast Center of Eastern Switzerland, (TBZO, St. Gallen site), Switzerland
- Chi-Cheng Huang
- Taipei Veterans General Hospital, Comprehensive Breast Health Center and Division of Breast Surgery, Taipei, Taiwan; National Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, Taiwan
- Omar Shamieh
- King Hussein Cancer Center, Department of Palliative Medicine, Amman, Jordan
- Monica Pinto
- Istituto Nazionale Tumori – IRCCS – Fondazione G. Pascale, Naples, Italy
- Yared Belete Belay
- Mekelle University, School of Pharmacy, Mekelle, Ethiopia; School of Public Health and Preventive Medicine, Monash University, VIC, Australia
- Samantha Serpentini
- Unit for Psychooncology, Veneto Institute of Oncology IOV e IRCCS, Padua, Italy
- Eveline Bleiker
- Netherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the Netherlands
- Manjunath Nookala Krishnamurthy
- Dept. of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India
- Akihiko Shimomura
- Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan
- Elisabeth C. Sturm-Inwald
- Department of Gynecology and Obstetrics, University Medical Center Regensburg, Regensburg, Germany
- Mikiyas Amare Getu
- Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia
- Brigitte Bliem
- Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria
- Guro Astrup
- Department of Oncology, Oslo University Hospital, Oslo, Norway
- Ofir Morag
- Cancer Pain Service, Chaim Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel
- Yuichiro Kikawa
- Kansai Medical University, Dept. of Breast Surgery, Osaka, Japan
- Karin Kuljanic
- Department of Obstetrics and Gynecology, Clinical Center Rijeka, Rijeka, Croatia
- Nora Nevries
- Breast Unit, Helios University Clinic Wuppertal, Germany
- Mirjam Sprangers
- Netherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the Netherlands
- Neil K. Aaronson
- Netherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the Netherlands
- Parisa Sinai
- Southmead Hospital, University of Bristol, Bristol, UK
- Krzysztof Tomaszewski
- Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland
- Razvan Galalae
- MedAustron, Neustadt, Austria
- Thierry Conroy
- Département d’oncologie médicale, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France
- Francois Duhoux
- Department of Medical Oncology, Institut Roi Albert II, Cliniques universitaires Saint-Luc (UCLouvain), Brussels, Belgium
- Wei-chu Chie
- National Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, Taiwan
- Galina Velikova
- Leeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UK; Leeds Cancer Centre, St James’s University Hospital, Leeds, UK
- Journal volume & issue
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Vol. 80
p. 103890
Abstract
Background: The EORTC QLQ-BR23, published in 1996, was one of the first disease-specific questionnaires to assess health-related quality of life (HRQoL) in patients with breast cancer (BC). In the last decades, major changes in BC treatment have occurred, requiring an update of this module. The results of the Phase 1–3 of the study were published in 2019. The aim of study was to examine the psychometric properties of the provisional EORTC-QLQ-BR45.questionnaire. Methods: Patients with a diagnosis of BC, age ≥18 years, and cognitive able to fill the questionnaire were included in the study and completed the provisional questionnaire during a visit at each participating centre. Psychometric analyses included the evaluation of the scale structure, internal consistency, test-retest reliability, convergent, discriminant, and clinical validity, and responsiveness to change. Results: Between May 2019 and September 2021, 576 patients from 22 centers (17 countries, 16 languages) were enrolled in the study. The psychometric analyses resulted in a final questionnaire containing 42 items divided into 10 scales: Breast Symptoms, Body Image, Sexual Functioning, Arm Symptoms, Systemic Chemotherapy Side Effects, Hand/Feet Symptoms/Neuropathy, Skeletal Symptoms, Endocrine Symptoms, Breast Satisfaction, Vaginal Symptoms, and 3 single items: Weight Gain, Sexual Enjoyment and Future Perspective. Conclusion: The revised EORTC QLQ-BR42 questionnaire incorporates the EORTC-QLQ-BR23 original items, combined with 19 new items that address the new therapies developed over the past 20 years. This comprehensive module is a valid instrument to assess the HRQoL of BC patients and can be used in place of the BR23 in future trials.
