The EORTC QLQ-BN20 questionnaire for assessing the health-related quality of life (HRQoL) in brain cancer patients: A phase IV validation study on behalf of the EORTC QLG, BCG, ROG, NCIC-CTG

Abstract

2041 Background: While new brain cancer therapies may help extend survival, both the disease and its treatment can have substantial impact on HRQoL. In this analysis we evaluated the psychometric properties of the EORTC QLQ-BN20, a brain cancer specific HRQoL questionnaire. Methods: Data were derived from two completed phase III EORTC / NCIC clinical trials including 891 brain cancer patients from 119 centers in 15 countries. Experimental treatments were surgery followed by radiotherapy and adjuvant PCV chemotherapy for highly anaplastic oligodendroglioma; and surgery followed by concomitant radiotherapy plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy for glioblastoma multiforme. Standard treatment consisted of surgery and postoperative radiotherapy alone. HRQoL assessments were performed before randomization, 1 month after ending radiation, and every 3 months after the start of chemotherapy. The BN20 scoring transforms 20 questions into 11 scales to assess neurological deficits (visual disorder, motor dysfunction, communication deficit), future uncertainty, and disease- and treatment-related symptoms. Multi-trait scaling analyses and sensitivity analyses were applied. Results: Baseline compliance was 83 %, decreasing to 58 % and 66% during follow-up. Mean age was 53 years. Missing data at the item level was modest (6% at baseline). All BN20 items correlated more strongly with their own scale (≥ 0.70) than with any other BN20 scale. Internal consistency reliability was high (0.72 ≤ α ≤ 0.88) for each BN20 scale. Known-groups comparisons yielded positive results, with 4 BN20 physical item/scale scores varying as a function of performance status (p < 0,0001); and BN20 communication deficit scores varying as a function of MMSE scores (p < 0.0001). Responsiveness was adequate, with expected patterns of change observed in BN20 physically-oriented scales as a function of performance status (p < 0.01); and BN20 future uncertainty decreasing over time (p < 0.0001). Conclusions: The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQoL of brain cancer patients. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Temodal/Temodar