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Effects of Cognitive Behavior Therapy in Severely Fatigued Disease-Free Cancer Patients Compared With Patients Waiting for Cognitive Behavior Therapy: A Randomized Controlled Trial

Marieke F.M. Gielissen, Stans Verhagen, Fred Witjes, Gijs Bleijenberg

From the Expert Centre Chronic Fatigue Nijmegen, and the Department of Medical Oncology and Urology, Radboud University, Nijmegen Medical Centre, Nijmegen, the Netherlands

Address reprint requests to Marieke Gielissen, MS, Expert Centre Chronic Fatigue (4628), Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, the Netherlands; e-mail: m.gielissen{at}nkcv.umcn.nl

PURPOSE: Persistent fatigue is a long-term adverse effect experienced by 30% to 40% of patients cured of cancer. The main objective of this randomized controlled trial was to show the effectiveness of cognitive behavior therapy (CBT) especially designed for fatigue in cancer survivors.

PATIENTS AND METHODS: A total of 112 cancer survivors with somatically unexplained fatigue were allocated randomly to immediate cognitive behavior therapy or to a waiting list condition for therapy. Both conditions were assessed two times, at baseline and 6 months later. The primary outcome variables were fatigue severity (Checklist Individual Strength) and functional impairment (Sickness Impact Profile). Data were analyzed by intention to treat.

RESULTS: Analyses were based on 50 patients in the intervention condition and 48 patients in the waiting list condition. Patients in the intervention condition reported a significantly greater decrease than patients in the waiting list condition in fatigue severity (difference, 13.3; 95% CI, 8.6 to 18.1) and in functional impairment (difference, 383.2; 95% CI, 197.1 to 569.2). Clinically significant improvement for the CBT group compared with the waiting list group was seen in fatigue severity (54% v 4% of the patients, respectively) and in functional impairment (50% v 18% of the patients, respectively).

CONCLUSION: Cognitive behavior therapy has a clinically relevant effect in reducing fatigue and functional impairments in cancer survivors.

Supported by the Dutch Cancer Society Grant No. KUN 2001-2378.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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