A randomised controlled trial of an optimized multidisciplinary intervention for post-cancer fatigue – TOPS Trial. (#71)
Cancer-related fatigue is a distressing and disabling symptom. When cancer-related fatigue persists beyond the treatment period and is unexplained by alternative medical or psychiatric conditions, it is termed post-cancer-fatigue (PCF)1.
Since currently no clear understanding of the aetiological basis of PCF exists and no effective prevention or treatment strategy has been defined, a pragmatic approach to intervention is required based on existing evidence for management of patients with chronic fatigue syndromes. It’s likely that cognitive-behavioural therapy (CBT)2,coupled with graded exercise therapy (GET)3 will improve functional outcomes. A randomised control trial - Treatment of Post-cancer fatigue Study has been developed assigning patients to receiving either an education intervention (n=50), or a 12-week supervised (by exercise physiologist and clinical psychologist), GET and CBT intervention (n=50). The intervention arm is based on the successful Fatigue Clinic program developed by the Lifestyle Clinic. Potential subjects are screened for clinically-significant fatigue at 3 months post successful-treatment for breast or bowel cancer.
Protocols and ethics applications have been established. Recruitment began recently with 83 potential participants approached. Current recruitment sites include Prince of Wales public (n=33) and private hospitals (n=23), St George public and private hospitals (n=5), Register4 website (n=9) and various private consulting rooms (n=13). 43 patients have been screen with 16 (37%) eligible and 8 enrolled most of whom are female (n=15) with breast cancer (n=15). Of the 27 (63%) ineligible patients mostly with breast cancer (n=20) and female (n=22), major reason for exclusion was reporting not clinically significant fatigue (44%). 36 patients remain to be screened and 4 have been lost to follow-up. The limitations with recruitment numbers to date reflect recent findings that the rate of post-cancer fatigue is not as high as previously thought. Focusing on identification of patients who are at higher risk of sustained fatigue may be beneficial.4
- Goldstein D, Bennett B, Friedlander M, Davenport T, Hickie I, Lloyd A. Fatigue states after cancer treatment occur both in association with, and independent of, mood disorder: a longitudinal study. BMC Cancer 2006;6:240.
- Gielissen MF, Verhagen S, Witjes F, Bleijenberg G. Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2006;24(30):4882-7
- Cramp F, Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev 2008(2):CD006145
- Goldstein D, Bennett BK, Webber K, Boyle F, de Souza PL, Wilcken NR, et al. Cancer-related fatigue in women with breast cancer: outcomes of a 5-year prospective cohort study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2012;30(15):1805-12