Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design

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.

Psychosocial, Cognitive, and Physical Impact of Elaborate Consultations and Life Review in Female Patients with Non-Metastasized Breast Cancer

“…More importantly, there was a marked difference in self-reported short-term fatigue in chemotherapy-treated patients between the two groups (p = 0.002). Our findings resemble results of a prospective multicenter trial with 105 non-metastasized breast cancer patients, where psychoeducation as part of a multimodal program (sleep education, eurythmy therapy, painting therapy) significantly reduced fatigue/disturbed sleep at 6 months after the end of intervention [42]. We assume that ECLR may ameliorate short-term physical and role functioning difficulties as well as the fatigue burden in patients receiving chemotherapy.…”

Implementation of an Integrative Oncological Concept in the Daily Care of a German Certified Breast Cancer Center

“…Preliminary results of our group have shown positive effects on the HRQL, including emotional and social functioning in primary breast cancer patients treated within an anthroposophical-integrative concept [43]. This is in line with a prospective, multicenter trial with 105 non-metastasized breast cancer patients, where a 10-week multimodal program including psycho-education, eurythmy, and painting therapy significantly reduced fatigue/disturbed sleep, showing superiority over aerobic training in an exploratory analysis [44]. International studies indicate a high interest in IM of breast cancer patients.…”

Nebenwirkungen komplementär behandeln

“…Die Wirksamkeit dieses Konzeptes in Bezug auf eine Verbesserung von Fatigue und Schlafqualität konnte inzwischen gezeigt werden. Dabei war der Effekt des multimodalen Vorgehens besser als bei einem alleinigen trainergeleiteten Ausdauertraining [28].…”