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 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.
Competing Interests: Declaration of competing interest VBR as PI has received grant from EORTC QoL Group for a project (Institution), consultings fees (Institution) from Pfizer, Lilly, FC has received consultings fees from Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, Gilead, GlaxoSmithKline, Iqvia, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva, Touchime, AB was an employee of the EORTC QoL Department, YK has received honoraria for lectures from Eisai, FAiichi Sankyo, Lilly, Chugai, Pfozer, AstraZeneca, Taiho, FPD has received grant from Fondation belge contre le cancer (Institution), consultings fees (Institution) and traveling support from Roche, Pfizer, AstraZeneca, Lilly, Novartis, Amgen, Daiichi Sankyo, Pierre Fabre, Gilead Sciences, Seagen, MSD, GV has received NIHR Programme grant NIHR Programme-development grant (Institution), has received consulting fees from Pfizer, Roche, Seagen, honoraria for lectures from Pfizer, Roche, Novartis, Eisai, Sanofi, Advisory Board member of Roche, Seagen, Astra Zeneca.
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