OS01.6.A EFFECTIVENESS OF BLENDED COGNITIVE BEHAVIORAL THERAPY IN ALLEVIATING SEVERE FATIGUE IN PATIENTS WITH DIFFUSE GLIOMA DURING STABLE DISEASE: A RANDOMIZED CONTROLLED TRIAL

Abstract BACKGROUND While severe fatigue is highly prevalent in patients with diffuse glioma, no evidence-based treatment is currently available. The objective of this randomized controlled trial was to demonstrate the efficacy of blended cognitive behavioral therapy (bCBT) specifically targeting severe fatigue in glioma patients. MATERIAL AND METHODS Severely fatigued patients (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue] ≥ 35) with diffuse glioma and stable disease were randomized to either a 12-week bCBT intervention or a waiting list control group (WLC). The primary outcome was fatigue severity (CIS-fatigue) at 14 weeks, with planned interim analysis to assess efficacy (claimed when the posterior probability that CIS-fatigue scores are lower in bCBT than in WLC is larger than 99%). Health-related quality of life (HRQoL), anxiety and depression were assessed as secondary outcomes at 14 and 24 weeks. RESULTS The trial was stopped early for efficacy at the first interim analysis, performed when primary outcome was available for 40 patients. At time of analysis, 47 patients were randomized, the mean age was 53 years and 47% were female. The posterior probability that CIS-fatigue scores were lower in bCBT arm was 0.9994, with a large standardized effect size (Cohen’s D) of 1.12 [95% CI: 0.43-1.81]. At 14 weeks, 32% of the patients were severely fatigued after bCBT, compared to 76% in the WLC group. Importantly, the effects of bCBT on fatigue were sustained at 24 weeks. Besides fatigue, bCBT also demonstrated medium to large effects on anxiety (post-treatment only) and HRQoL (both post-treatment and at follow-up). CONCLUSION Blended CBT is highly effective in reducing severe fatigue in patients with diffuse glioma and additionally improves anxiety and HRQoL. Proving the effectiveness of bCBT is a critical step towards evidence-based care and improved HRQoL for glioma patients.