Abstract
BackgroundCancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). Aerobic training (AT), the standard therapy for CRF in BC, shows only minor to moderate treatment effects. Other evidence-based treatments include cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies. We investigated the effectiveness of a 10-week multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT) and compared both arms to AT alone.MethodsIn a pragmatic comprehensive cohort study BC with chronic CRF were allocated randomly or by patient preference to (a) MT, (b) CT (MT + AT) or (c) AT alone. Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention (T1); a second endpoint was a follow-up assessment 6 months later (T2). The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1. A closed testing procedure preserved the global α-level. The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment, respectively.ResultsAltogether 126 BC were recruited: 65 were randomized and 61 allocated by preference; 105 started the intervention. Socio-demographic parameters were generally balanced at baseline. Non-inferiority of MT to AT at T1 was confirmed (p < 0.05), yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT (p = 0.119). In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively.ConclusionsThe multimodal CRF-therapy was found to be confirmatively non-inferior to standard therapy and even yielded exploratively sustained superiority. A randomized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted.Trial registerDRKS-ID: DRKS00003736. Recruitment period June 2011 to March 2013. Date of registering 19 June 2012.
Highlights
Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC)
132 breast cancer patients with a significant chronic cancer-related fatigue were assessed for eligibility and from these 126 were included in the study (65 randomized and 61 assigned by preference; Fig. 2). 28, 44 and 54 patients were randomly allocated to/ preferred the aerobic (AT: 22/ 6), multimodal (MT: 21/ 23) and combination arm (CT: 22/ 32), respectively. 20 patients who did not participate in the baseline assessment or any intervention were excluded from the Intentionto-Treat analysis (ITT)
The study arms were comparable with regard to time since first diagnosis, tumor biology, stage and treatment, or to socio-demographic characteristics (Table 2) except of a smaller average height in the Aerobic training (AT)-group (163 cm compared to 168 cm and 167 cm in the combination with AT (CT) and multimodal program (MT) group, respectively; p = 0.0168), less HADS-anxiety (MT: mean = 7.3 (SD = 3.1); AT: mean = 9.4 (4.3); CT: mean = 9.3 (3.5); p = 0.0263), less rehabilitation (MT = 11.76%; AT = 35%; CT = 31.37%; p = 0.027) and ‘other disorders’ (p = 0.0313) in the MT group compared to AT and CT
Summary
Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). The treatment of CRF with the best available evidence in breast cancer is aerobic training, showing a minor to moderate (standardized mean-differences) effect size of 0.27 to 0.315 [8, 9]. Cognitive behavioral approaches such as psycho-education yield minor effect sizes [9], while sleep educational approaches including sleep-restriction and stimulus control [10, 11] show minor to moderate effect sizes comparable with mindfulness-based interventions [12, 13]. Another pharmacological approach is mistletoe treatment, for which positive results in the reduction of fatigue have been published; trials using sufficiently robust fatigue measures with CRF as primary outcome are still lacking [16]
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