Grant: Operating Grant: Priority Announcement (IHSPR)

Project summary: Quality of life (QOL) outcomes are increasingly important in clinical trials involving patients with brain metastases. Currently, there is no brain metastases specific QOL questionnaire for this patient population, which significantly limits comparison between trials. Previous research: EORTC refined the core QOL questionnaire and developed the EORTC-QLQ-C15-PAL, which consists of 15 items. The condensed C15-PAL questionnaire has been validated in the palliative cancer population. Instruments specifically designed to assess QOL in brain metastasis patients are limited. The European Organization for Research and Treatment of Cancer Brain Module (EORTC-QLQ-BN20) was developed and validated to assess QOL in patients with primary brain tumors. This questionnaire will be administered alongside the EORTC-QLQ-C30 core questionnaire to produce a 50-item QOL assessment tool. Project description: It is essential to devise and employ a questionnaire with a minimal number of items that accurately assesses QOL in patients with brain metastases. In order to adhere to this research objective, we have elected to validate the EORTC-QLQ-BN20 module in conjunction with the EORTC-QLQ-C15-PAL, which produces a total of 35 items. Validation of this questionnaire will be conducted according to the EORTC Guidelines among patients with brain metastases. Impact and relevance: The Cochrane Collaboration has expressed the immediate need to include QOL as a standardized endpoint in future clinical trials involving patients with brain metastases. Nonetheless, QOL outcomes have traditionally been underreported in the previously-conducted investigations. Therefore, the validation of a widespread QOL assessment tool for patients with brain metastases is a critical step in future research involving this patient population. Through content validation of the EORTC-QLQ-BN20, necessary QOL documentation and comparison will be facilitated.