Which quality of life issues are important to patients with metastatic breast cancer: Phase 1 and 2 development of European Organisation for Research and Treatment of Cancer metastatic breast cancer module (EORTC QLQ-MBR).

BACKGROUND: Metastatic breast cancer (MBC) remains a treatable, but incurable disease. Anti-cancer treatments and supportive therapies aim to control disease, prolong survival, ameliorate physical symptoms and improve quality of life (QoL). Currently, no validated MBC-specific patient-reported outcome measures exist, and existing tools may lack specific content and sensitivity to measure the impact of MBC. This study aims to develop a European Organisation for Research and Treatment of Cancer (EORTC) module for MBC. METHODS: Development followed EORTC module guidelines. In phase 1, QoL issues were identified via systematic literature reviews and assessed by semi-structured interviews with healthcare professionals (HCPs) and patients. In phase 2, the most relevant and important issues were converted into questionnaire items using the EORTC Item Library to form the provisional module. RESULTS: The review included 103 papers (phase III clinical trials n = 70 and observational or qualitative studies n = 33), from which 185 issues were extracted, spanning physical, psychological, emotional and social domains. Interviews with 41 HCPs and 187 patients from eight countries refined this list to 44. After expert panel review, the provisional module consisted of 40 issues, assessed by 44 items (EORTC QLQ-MBR44). A sub-analysis of the EORTC QLQ-C30 revealed its content to be considered relevant to MBC by HCP and patients. CONCLUSION: The provisional EORTC MBC-specific module aims to enhance understanding and measurement of QoL in clinical research and care and be the first QoL tool dedicated to MBC. The standardised tool contains relevant QoL issues and is currently undergoing qualitative and psychometric testing.