TY - JOUR
T1 - Bayesian Adaptive Randomized Trial of Blended Cognitive Behavioral Therapy for Severe Fatigue in Stable Diffuse Glioma
AU - Gorter, Maxine
AU - Röttgering, Jantine G
AU - Belgers, Vera
AU - Blom, Marieke E C
AU - Thomassen, Brigit
AU - De Witt Hamer, Philip C
AU - Niers, Johanna M
AU - Kouwenhoven, Mathilde C M
AU - Bienfait, Henri P
AU - Gathier, Celine S
AU - Compter, Annette
AU - Geurts, Marjolein
AU - Snijders, Tom J
AU - Van De Ven, Peter M
AU - Douw, Linda
AU - Knoop, Hans
AU - Klein, Martin
N1 - © The Author(s) 2025. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.
PY - 2025/11/9
Y1 - 2025/11/9
N2 - BACKGROUND: While severe fatigue is common in patients with diffuse glioma, no evidence-based treatment is currently available. The objective of this RCT was to evaluate efficacy of blended cognitive behavioral therapy (bCBT) for severe fatigue.METHODS: Severely fatigued patients (Checklist Individual Strength, fatigue-severity subscale [CIS-fatigue] ≥ 35) with diffuse glioma and stable disease were randomized to 12 weeks of bCBT or a waiting list condition (WLC). The primary endpoint was fatigue severity 2 weeks after intervention. This Bayesian adaptive trial included prespecified interim analyses for efficacy at n = 40, 50, 60, 70, and 80. Secondary outcomes-health-related quality of life (HRQoL), anxiety, future uncertainty and depression-were assessed at 2 and 12 weeks after intervention.RESULTS: The trial was stopped for efficacy at the first interim analysis. Of 47 patients randomized, 40 patients reached primary endpoint (mean age 53 years, 47% female). The posterior probability that CIS-fatigue scores were lower with bCBT than with WLC was 99.94%, with a large standardized effect size (Cohen's d) of 1.12 [95% CI: 0.43-1.81]. At 2 weeks after intervention, 68% of patients were no longer severely fatigued after bCBT, compared to 24% in WLC. At 12 weeks follow-up, fatigue was still significantly lower in the bCBT group compared to WLC (d = 1.22). bCBT also demonstrated beneficial effects (d = 0.42-1.19) on anxiety, HRQoL, and future uncertainty.CONCLUSIONS: bCBT significantly reduces fatigue and improves anxiety and HRQoL in patients with diffuse glioma. These findings enable evidence-based supportive care strategies for reducing fatigue and enhancing HRQoL in this population.
AB - BACKGROUND: While severe fatigue is common in patients with diffuse glioma, no evidence-based treatment is currently available. The objective of this RCT was to evaluate efficacy of blended cognitive behavioral therapy (bCBT) for severe fatigue.METHODS: Severely fatigued patients (Checklist Individual Strength, fatigue-severity subscale [CIS-fatigue] ≥ 35) with diffuse glioma and stable disease were randomized to 12 weeks of bCBT or a waiting list condition (WLC). The primary endpoint was fatigue severity 2 weeks after intervention. This Bayesian adaptive trial included prespecified interim analyses for efficacy at n = 40, 50, 60, 70, and 80. Secondary outcomes-health-related quality of life (HRQoL), anxiety, future uncertainty and depression-were assessed at 2 and 12 weeks after intervention.RESULTS: The trial was stopped for efficacy at the first interim analysis. Of 47 patients randomized, 40 patients reached primary endpoint (mean age 53 years, 47% female). The posterior probability that CIS-fatigue scores were lower with bCBT than with WLC was 99.94%, with a large standardized effect size (Cohen's d) of 1.12 [95% CI: 0.43-1.81]. At 2 weeks after intervention, 68% of patients were no longer severely fatigued after bCBT, compared to 24% in WLC. At 12 weeks follow-up, fatigue was still significantly lower in the bCBT group compared to WLC (d = 1.22). bCBT also demonstrated beneficial effects (d = 0.42-1.19) on anxiety, HRQoL, and future uncertainty.CONCLUSIONS: bCBT significantly reduces fatigue and improves anxiety and HRQoL in patients with diffuse glioma. These findings enable evidence-based supportive care strategies for reducing fatigue and enhancing HRQoL in this population.
U2 - 10.1093/neuonc/noaf256
DO - 10.1093/neuonc/noaf256
M3 - Article
C2 - 41208030
SN - 1522-8517
JO - Neuro-oncology
JF - Neuro-oncology
ER -