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 comprehensivReportar como inadecuado




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 comprehensiv - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Cancer

, 17:166

Epidemiology, prevention and public health

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.

KeywordsAerobic training Anthroposophic medicine Cognitive behavior therapy Breast cancer Cancer-related fatigue Eurythmy therapy Multimodal intervention Painting therapy Sleep education Sleep restriction AbbreviationAEsAdverse events

ATAerobic training

BCBreast cancer survivors

CFSCancer Fatigue Scale

CFS-DCancer Fatigue Scale German version

COPDChronic obstructive pulmonary disease

CRFCancer-related Fatigue

CTCombination therapy

HADSHospital Anxiety and Depression Scale

ITTIntention-to-Treat analysis

LOCFLast-value-carried-forward

MTMultimodal therapy

NYHANew York heart association functional classification

PC-scorePrincipal component score

PSPropensity scores

PSQIPittsburgh sleep quality index

RCTRandomized controlled trial

SAESerious adverse event

SDStandard deviation

SESleep education-restriction

T0Time baseline measurement

T1Time after 10 weeks intervention

T2Time after 6 months intervention

TESSTreatment-emergent signs and symptoms

TSHThyroid-stimulating hormone





Autor: Matthias Kröz - Marcus Reif - Augustina Glinz - Bettina Berger - Andreas Nikolaou - Roland Zerm - Benno Brinkhaus - Matthi

Fuente: https://link.springer.com/



DESCARGAR PDF




Documentos relacionados