The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires

Abstract

A self-report questionnaire module consisting of 24 items, comprising 5 scales and 7 single items, has been developed for measuring health-related quality of life in patients with brain cancer. Module development proceeded through several stages, including a listing of patient, family and health care professional concerns, the writing of items, field testing in 105 patients with brain cancer and subsequent item reduction and scale construction after multitrait scaling analysis and assessment of internal consistency (Cronbach's coefficient alpha). The final version of the module exhibits reasonable test-retest stability over a period of one week. Differences in the responses between patients with recently-diagnosed and recurrent cancer and between patients with a Karnofsky Performance Score (KPS) of 50-70 and 80-100 were in the expected direction, indicating that the module of questions is responsive to differing conditions. Patients with either mental confusion, motor deficit or dysphasia indicated problems in several domains and single items as compared to patients without these neurological deficits. Thus, differences in the responses to the items in the brain cancer module appear to reflect differences in neurological status. In addition, deteriorating neurological status was accompanied by a marked increase in emotional distress, future uncertainty and motor dysfunction. A comparison of the responses in the module with the KPS and with a modified Barthel Activities of Daily Living Index (BADLI) shows moderate correlations, primarily with scales and items that pertain to motor dysfunction, while other scales (such as emotional distress, visual disorder and communication deficit) and most single items are not associated with the KPS or BADLI. Since the emotional distress scale of the module was found to be highly correlated with the emotional function scale of the EORTC QLQ-C30, it could be omitted when the module is used in combination with the QLQ-C30. This would reduce the module to a total of 20 items with four scales and seven single items. The intention is to combine this module of questions with other core or general quality-of-life questionnaires when studying patients with brain cancer in clinical trials.

Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

“…Two HRQOL measures were selected: the EORTC Quality of Life Questionnaire C30 (EORTC-QLQ-C30, version 3) 6 and the EORTC QLQ Brain Cancer Module (EORTC-QLQ-BN20). 7 Both tools have robust psychometric properties resulting from rigorous testing, development, and external validity, and in the case of the core tool from their use in hundreds of cancer RCTs. 8 The EORTC QLQ-C30 is a core measure designed to be supplemented with disease-specific questionnaires, in this case EORTC QLQ-BN20.…”

Bevacizumab plus Radiotherapy–Temozolomide for Newly Diagnosed Glioblastoma

“…[27][28][29] Patients completed the questionnaires without assistance. Five scales were prespecified for the primary analysis of deterioration-free survival: global health status, physical functioning, social functioning, motor dysfunction, and communication deficit.…”

A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse

“…Worsening neurologic deficit was considered as a physical finding associated with neurologic examination rather than an AE. Osoba et al, 1997) and the Brain Cancer Module 20 (BCM20) (Osoba et al, 1996) questionnaires were used to measure HRQL. Questionnaires were administered on day 1 of cycle 1 and at every visit throughout the study.…”