TOPS trial: Treatment of Post-Cancer Fatigue Study

Interventions: This randomized control trial will assign patients to receive either:
Arm 1: a simple education intervention - consisting of patient information booklet outlining the principles of the management program implemented in the CBT intervention and will meet with the clinicians (both the exercise physiologist and clinical psychologist) once, for approximately 45 mins, to further discuss the principles of the intervention.
Arm 2: a 12-week supervised, graded exercise program (GET) and cognitive behavioral therapy (CBT) intervention aimed at managing the fatigue state and improving functional status. The program consists of exercise / activity and psychological interventions and is conducted by trained exercise physiologists and clinical psychologists, based on consultations of 45mins each. In week 1, before commencing any exercise program the participants’ current exercise / activity capacity will be assessed by interview and by completion of a diary. The planned exercise / activity program will be tailored to the subjects’ capacity. Progress will be reviewed at weeks 2, 3, 5 and 7, either in person or by telephone, each consultation taking approximately 45mins.
At the end of 12 weeks and again at 24 weeks, subjects in both arms of the study will be interviewed (for approximately one hour) and have their exercise capacity reassessed via a consultation of approximately one hour.
Primary outcome(s): Improvement in the clinically-significant fatigue state identified by interviews conducted by a psychologist independent of the treating practitioners utilizing the SCIN (The Structured Clinical Interview for Neurasthenia [Bennett B et al, manuscript submitted]. A decrease of one standard deviation (SD) or greater from baseline to week 12 and week 24 on of the global score (previous studies by the investigators indicate one SD equates to 2.8 points on the scoring algorithm which has a possible range of 0-15).[Baseline (pre-intervention), 12 weeks (immediately post-intervention) and 24 weeks (in follow-up).]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety