Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

Abstract

Purpose Fatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly co-exists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a 4-arm RCT study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors. Patients and Methods This study was a four arm factorial study with CBTI-I (Yes/No) versus A (Yes/No). It consisted of 96 cancer survivors (Average age 56 years; 88% female; 68% breast cancer). Fatigue was assessed by the Brief Fatigue Inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A, and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A. Results Analyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P=0.002, Std. Error=0.32, effect size (ES)=0.46; FACIT-Fatigue: P<0.001, Std. Error=1.74, ES=0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps>0.40), nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue. Conclusions CBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve CRF and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.

Are we sleeping on the job? Insomnia among men with prostate cancer

“…A recent systematic review concluded that the quality of the evidence supported a strong recommendation for the use of CBT among cancer survivors experiencing insomnia [58] . CBT interventions also had a positive effect on daytime fatigue, at least in the short term [57] . However, the majority of these studies have been undertaken among women with localised breast cancer [55,56,58] .…”

“…However, cognitive behavioural therapy (CBT) aimed at changing beliefs and attitudes about insomnia in conjunction with behavioural therapy, is considered the gold standard, non-pharmaceutical management of insomnia. CBT has been found to successfully improve many dimensions of insomnia including increased sleep effectiveness, and reduced sleep latency, nocturnal awakenings and insomnia severity in cancer patients who received CBT compared to those who did not [56][57][58] . A recent systematic review concluded that the quality of the evidence supported a strong recommendation for the use of CBT among cancer survivors experiencing insomnia [58] .…”

Intervenções cognitivas e comportamentais para manejo de insônia em pacientes oncológicos

“…Nota-se o fato que no período de 2010 a 2015 as pesquisas acerca do tema se direcionaram fundamentalmente na busca de novas alternativas terapêuticas que busquem acessibilidade dos pacientes às intervenções, ou o uso de Mindfulness (Casault et al, 2015;Fleming et al, 2014;Garland et al, 2011;Garland et al, 2014;Heckler et al, 2015;J. Savard et al, 2014;Matthews et al, 2014;Ritterband et al, 2012 No entanto, o que se evidenciou a respeito desta técnica de uma maneira geral é que apesar dos resultados positivos, ainda não se mostrou superior e mais rápida quando comparada às intervenções clássicas (Garland et al, 2011;Garland et al, 2014;Geiger-Brown et al, 2015;Gu, Strauss, Bond, & Cavanagh, 2015;Kabat-Zinn, 1990).…”

“…Em relação ao momento da intervenção, seis estudos (75%) foram realizados após pelo menos 30 dias do término do tratamento, com pacientes que ainda apresentavam insônia (Fleming et al, 2014;Garland et al, 2011;Garland et al, 2014;Heckler et al, 2015;Matthews et al, 2014;Ritterband et al, 2012). Por fim, um artigo foi realizado em radioterapia (J.…”

“…Outra intervenção autoaplicável em pacientes em diversos momentos do tratamento demonstrou ser eficaz, porém ela compreendia três ligações telefônicas breves de orientação (Casault et al, 2015). Os demais três estudos (Fleming et al, 2014;Heckler et al, 2015;Matthews et al, 2014) também demonstraram eficácia nos diversos contextos aos quais foram empregados.…”