Barriers to Recruitment for a Post-Cancer Fatigue Intervention Study - The TOPS Trial. (#193)
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. It has been rated by patients as the most prominent symptom experienced after cancer therapy2. Preliminary data suggest that cognitive-behavioural therapy (CBT)3,coupled with graded exercise therapy (GET)4 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 psychologist), GET and CBT intervention (n=50). Potential subjects are screened for clinically-significant fatigue at 3 months post successful-treatment for breast or bowel cancer.
Recruitment began in late 2012 with 158 potential participants approached to date. Recruitment sites include Prince of Wales public (n=61) and private hospitals (n=51), St George public and private hospitals (n=11), Register4 (n=12) and various private consulting rooms (n=23). 89 patients have been screened with 38 (43%) deemed eligible, and 22 enrolled, including n=20 women with breast cancer. 12 patients were eligible but were not enrolled due to other competing time commitments (67%) and 4 in progress. Of the 51(57%) ineligible patients, the major reason for exclusion was sub-threshold fatigue severity (61%). 62 patients are in screening, and 7 have been lost to follow-up.
These limitations in recruitment to date are likely to reflect recent findings that the rate of post-cancer fatigue is lower than previously thought5. Focussing on identification of patients who are at higher risk of sustained fatigue may improve enrolment rates. In contract to pharmacological interventions, behavioural treatment programs have significant time demands which may also limit recruitment.
- Goldstein, D., et al., Fatigue states after cancer treatment occur both in association with, and independent of, mood disorder: a longitudinal study. BMC Cancer, 2006. 6: p. 8.
- Cella, D., et al., Progress toward guidelines for the management of fatigue. Oncology (Williston Park), 1998. 12(11A): p. 369-77.
- Gielissen, M.F.M., et al., 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, 2006. 24(30): p. 4882-7.
- Cramp, F. and J. Byron-Daniel, Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev, 2012. 11: p. CD006145.
- Goldstein, D., et al., Cancer-related fatigue in women with breast cancer: outcomes of a 5-years prospective cohort study. Journal of clinical oncology, 2012. 30: p. 1-9