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
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 resu...
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2025-04-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Vesna Bjelic-Radisic |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7f9e86d45cad4be3be9df82c34b58c90 |
| institution | Kabale University |
| issn | 1532-3080 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Breast |
| spelling | doaj-art-7f9e86d45cad4be3be9df82c34b58c902025-08-20T03:42:41ZengElsevierBreast1532-30802025-04-018010389010.1016/j.breast.2025.103890An international Phase IV field study - psychometric properties of the updated module on assessing quality of life of patients with breast cancer EORTC QLQ-BR42Vesna Bjelic-Radisic0Fatima Cardoso1Joachim Weis2Katarzyna Pogoda3Juan Ignacio Arraras4Elfriede Greimel5Andrew Bottomley6David Cameron7Etienne Brain8Sue Hartup9René Aloisio da Costa Vieira10Nicolette Hoefnagels11Chi-Cheng Huang12Omar Shamieh13Monica Pinto14Yared Belete Belay15Samantha Serpentini16Eveline Bleiker17Manjunath Nookala Krishnamurthy18Akihiko Shimomura19Elisabeth C. Sturm-Inwald20Mikiyas Amare Getu21Brigitte Bliem22Guro Astrup23Ofir Morag24Yuichiro Kikawa25Karin Kuljanic26Nora Nevries27Mirjam Sprangers28Neil K. Aaronson29Parisa Sinai30Krzysztof Tomaszewski31Razvan Galalae32Thierry Conroy33Francois Duhoux34Wei-chu Chie35Galina Velikova36Breast 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.Breast Unit Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, PortugalComprehensive Cancer Center, Medical Faculty, University Medical Center Freiburg, Freiburg, GermanyDepartment of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, PolandDepartment of Oncology, University Hospital of Navarre, Pamplona, SpainDepartment of Obstetrics and Gynecology, Medical University Graz, Graz, AustriaEORTC HQ, Quality of Life Department, Brussels, BelgiumCancer Research UK Edinburgh Centre, University of Edinburgh, Edinburgh, UKDepartment of Medical Oncology, Institut Curie, Saint-Cloud, FranceBreast 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, UKDepartment of Mastology and Breast Reconstruction, Barretos Cancer Hospital, Barretos, BrazilTumor- and Breast Center of Eastern Switzerland, (TBZO, St. Gallen site), SwitzerlandTaipei Veterans General Hospital, Comprehensive Breast Health Center and Division of Breast Surgery, Taipei, Taiwan; National Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, TaiwanKing Hussein Cancer Center, Department of Palliative Medicine, Amman, JordanIstituto Nazionale Tumori – IRCCS – Fondazione G. Pascale, Naples, ItalyMekelle University, School of Pharmacy, Mekelle, Ethiopia; School of Public Health and Preventive Medicine, Monash University, VIC, AustraliaUnit for Psychooncology, Veneto Institute of Oncology IOV e IRCCS, Padua, ItalyNetherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the NetherlandsDept. of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, IndiaDepartment of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, JapanDepartment of Gynecology and Obstetrics, University Medical Center Regensburg, Regensburg, GermanyTikur Anbessa Specialized Hospital, Addis Ababa, EthiopiaDepartment of Obstetrics and Gynecology, Medical University Graz, Graz, AustriaDepartment of Oncology, Oslo University Hospital, Oslo, NorwayCancer Pain Service, Chaim Sheba Medical Center, Tel HaShomer, Ramat Gan, IsraelKansai Medical University, Dept. of Breast Surgery, Osaka, JapanDepartment of Obstetrics and Gynecology, Clinical Center Rijeka, Rijeka, CroatiaBreast Unit, Helios University Clinic Wuppertal, GermanyNetherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the NetherlandsNetherlands Cancer Institute, Psychosocial Research and Epidemiology, Amsterdam, the NetherlandsSouthmead Hospital, University of Bristol, Bristol, UKFaculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, PolandMedAustron, Neustadt, AustriaDépartement d’oncologie médicale, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, FranceDepartment of Medical Oncology, Institut Roi Albert II, Cliniques universitaires Saint-Luc (UCLouvain), Brussels, BelgiumNational Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, TaiwanLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UK; Leeds Cancer Centre, St James’s University Hospital, Leeds, UKBackground: 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.http://www.sciencedirect.com/science/article/pii/S0960977625000190Breast cancerQuality of lifeQuestionnaireEORTCPsychometrics |
| spellingShingle | 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 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 Breast Breast cancer Quality of life Questionnaire EORTC Psychometrics |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | international phase iv field study psychometric properties of the updated module on assessing quality of life of patients with breast cancer eortc qlq br42 |
| topic | Breast cancer Quality of life Questionnaire EORTC Psychometrics |
| url | http://www.sciencedirect.com/science/article/pii/S0960977625000190 |
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