Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: results of Radiation Therapy Oncology Group trial BR-0018

Abstract

Purpose A multi-institutional trial was conducted by the Radiation Therapy Oncology Group (RTOG) to test the feasibility of performing a test battery consisting of five neurocognitive measures and a quality-of-life instrument in patients with brain metastases. Methods and materials The major eligibility requirements included histologic proof of a primary malignancy, measurable single or multiple brain metastases, Zubrod performance status of 0–1, neurologic function status of 0–2, and “certification” for administration of neurocognitive assessments. This certification process required either attendance at an RTOG neurocognitive assessment training workshop or review of an instructional video, followed by submission of an audiotape of mock/simulated test sessions for central review. The test battery included the following measures: the Mini-Mental Status Examination, Hopkins Verbal Learning Test, Verbal Fluency/Controlled Word Association Test, Ruff 2 and 7 test, Trailmaking Test, and Profile of Mood States-Short Form. The primary objective of this trial was to establish whether patients were able to complete this test battery. Compliance was defined as successful completion of a test measure. The test battery was to be administered just before, at completion of, and 1 month after whole brain radiotherapy to 37.5 Gy at 2.5 Gy/fraction once daily. Fifty-nine patients were enrolled in the trial. Results The patient characteristics included 32% ≥65 years; 44% with Zubrod performance status of 0; and 81% with multiple brain metastases. The overall compliance rate for administration and completion of the five neurocognitive measures and a quality-of-life instrument before treatment, at treatment completion, and 1 month after treatment was ≥95%, ≥84%, and ≥70%. The most common causes of noncompliance were patient-related factors (e.g., performance status or inability to understand test instructions) and not institutional error. Conclusion Neurocognitive evaluation of patients with brain metastases in a multi-institutional and cooperative group setting is feasible using the test battery and certification process used in this study. This battery and certification process will be incorporated into future RTOG brain tumor trials.