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Influence of multimodal treatment on rest/activity and autonomic regulation in breast cancer patients with cancer related fatigue - results of a tri-center trial with a comprehensive cohort design.

INTRODUCTION
Breast cancer patients with cancer-related fatigue (BC-CRF) often have lower physical activity. To investigate how this could be improved we evaluated a multimodal treatment (MT) and a combination of MT with aerobic training (CT) were and compared these with aerobic training (AT) regarding rest/activity rhythm and state autonomic regulation (State aR).


METHODS
In this pragmatic comprehensive cohort design study the explorative analysis focused on actigraphy and State aR including the rest/activity regulation subscale (State aR-R/A) which were assessed at baseline (T0), after ten weeks of intervention (T1) and State aR additionally six months later (T2).


STATISTICS
General linear modelling including propensity scores.


RESULTS
65 BC-CRF were randomised and 61 allocated by preference to the treatment arms. 105 patients started the intervention. At T1 State aR-R/A improved the most in MT (+3.49, CI [2.42; 4.55]) compared to AT (+1.59, CI [0.13; 3.06] and CT (+1.68, CI [0.83; 2.52]) showing superiority of MT to AT (p=0.048). At T2 MT was sustainably superior to AT regarding State aR-R/A (+3.61, CI [2.38; 4.83] p<0.01) and State aR also showed superiority of MT to AT (p=0.006). AT T1 24-hour activity was higher in MT compared to AT (p=0.029).


CONCLUSIONS
MT was superior to AT regarding State aR total score after six months, State aR-R/A after 10 weeks and after six months. Actigraphically measured total activity also improved after 10 weeks.