Study Protocol for a Randomized Controlled Trial Evaluating the Efficacy of an Evidence-Based iPad-App for Cognitive Rehabilitation in Patients with Primary Brain Tumors

BACKGROUND: Many patients with primary brain tumors suffer from cognitive deficits, which negatively impact their quality of life. However, cognitive rehabilitation programs for these patients are scarce. We developed an iPad-based cognitive rehabilitation program for brain tumor patients, which was based on our effective face-to-face cognitive rehabilitation program. After successful completion of a feasibility study, a randomized controlled trial has been started. OBJECTIVE: To evaluate the immediate and long-term effects of the iPad-based program on cognitive performance and patient-reported outcome measures (PROMs) in patients with primary brain tumors in an early stage of the disease. METHODS: Prior to surgery, patients with presumed low-grade glioma and meningioma are included. Before surgery and 3 mo after surgery, neuropsychological assessments are conducted. After the second neuropsychological assessment, patients are assigned to the intervention group or waiting-list control group. The intervention consists of psychoeducation, compensation training, and retraining. Patients are advised to spend 3 h per week on the program for 10 wk. Immediately after completion of the program and a half-year thereafter, postintervention assessments take place. Patients in the control group are offered the opportunity to follow the program after all study assessments. EXPECTED OUTCOMES: We expect that early cognitive rehabilitation has beneficial effects on cognitive performance and PROMs in brain tumor patients. DISCUSSION: The iPad-based program allows brain tumor patients to follow a cognitive rehabilitation program from their homes. Forthcoming results may contribute to further improvement of supportive care for brain tumor patients.