Aim: The aim of this study was to develop a bone metastases module to supplement the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) or the EORTC QLQ-C15-PAL for patients with bone metastases.
Methods: Phases 1-2 of module development were conducted in Canada, Australia and Germany according to EORTC QOL group guidelines. Phase 3 was conducted in nine countries in seven languages.
Results: Sixty-one health-related quality of life (HRQOL) issues were generated from health care professionals (n=152) and patients (n=413). This resulted in a 22-item provisional module. Further testing in 170 patients from nine countries resulted in the EORTC QLQ-BM22 module, containing 22 items, conceptualised into both symptom scales, with five painful sites and three pain characteristics, and also functional scales, with eight functional interference and six psychosocial aspects.
Conclusion: This study provides a provisional comprehensive HRQOL measurement tool for future trials, which will continue to undergo further validation.