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TIRED: A randomised controlled trial evaluating efficacy of cognitive behavior therapy and graded exercise therapy in severely fatigue patients with advanced cancer.

183 Background: Patients with advanced, metastatic cancer frequently suffer from severe fatigue. We assessed the effect of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) on fatigue during cancer treatment with palliative intent. Methods: This randomized study took place between Jan 1, 2013 and Sep 1, 2017 at Radboud University Medical Center (Nijmegen, Netherlands). We enrolled adult patients from nine medical oncology clinics. Eligible patients had advanced cancer and reported severe fatigue (Checklist Individual Strength, subscale fatigue severity [CIS fatigue] ≥ 35) during cancer treatment. Participants were randomized to CBT, GET, or usual care (1:1:1 ratio, using a computer-generated sequence, stratified by study site and minimized for sex). We measured fatigue (CIS fatigue and European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 [EORTC-QLQ-C30] fatigue), quality of life, emotional functioning, physical functioning (all by EORTC-QLQ-C30), and functional impairments (Sickness Impact Profile [SIP8]) at baseline, 14, 18, and 26 weeks. The primary outcome was CIS fatigue at 14 weeks; secondary outcomes included scores for the aforementioned scales. We registered the trial with TrialRegister.nl (NTR3812). Results: 134 participants completed baseline measures (46 CBT, 42 GET, 46 usual care); 126 completed assessment at 14 weeks. There was a significant difference in CIS fatigue scores between CBT and usual care (-7.22, 97.5% CI -12.73 to -1.72; p = .003, d= 0.72), but no significant difference between GET and usual care (-4.70, -10.24 to 0.85, p = .057, d= 0.44). Secondary outcomes showed significant differences for EORTC-QLQ-C30 fatigue (-13.05 [95% CI -22.12 to -3.97]; p = 0.005), quality of life (10.15 [2.37 to 17.93]; p = 0.11), and physical functioning (7.10 [0.48 to 13.72]; p = 0.036), but not for emotional functioning or SIP8 functional impairments (p's > 0.05). There were no significant differences in secondary outcomes between GET and usual care. Conclusions: The findings support CBT for severe fatigue in patients with advanced cancer during treatment. Clinical trial information: NTR3812.