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Randomized Controlled Clinical Effectiveness Trial of Cognitive Behavior Therapy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer
Abstract
PURPOSE: Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. PATIENTS AND METHODS: Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. RESULTS: CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CONCLUSION: CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.
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“Improving sleep has also been shown to improve aspects of physical health, including fatigue [81], chronic pain [82,83], and overall health related quality of life [84]”
From Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials (2021) · cites this paper as [81]
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“Consistent with previous findings that corroborate CBTi as an effective treatment for insomnia in medical populations (Espie et al., 2008), group main effects revealed that CBTi.p. participants had higher SE and lower TWT and SOL across timepoints compared to PE participants.”
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“A general rule is that a d of 0.2 is small, 0.5 is medium and 0.8 is large. d values were provided by six papers (Dirksen & Epstein, 2008; Espie et al., 2008; Lin et al., 2019; Ritterband et al., 2012; Savard et al., 2014; Zachariae et al., 2018), and for one paper, a value can be calculated using…”
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“In addition to medication, psychotherapy including cognitive behavioral therapy (23,24) and relaxation therapy (22,25) could offer alternative support if these services are available.”
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Moorey, S. (2013) · Psycho-Oncology · doi:10.1002/pon.3297 · Cited by 15
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Fleming, L., & Macmahon, K. (2015) · Current Sleep Medicine Reports · doi:10.1007/s40675-015-0021-0 · Cited by 16
“The largest of these trials using face-to-face CBT-I was conducted by Espie et al (2008) (20).”
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Savard, J., Savard, M., & Ivers, H. (2016) · Behavioral Sleep Medicine · doi:10.1080/15402002.2016.1210148 · Cited by 14
“Several randomized controlled trials (RCTs) have also supported the efficacy of CBT-I among cancer patients (Epstein & Dirksen, 2007; Espie et al., 2008; Fiorentino et al., 2009; Garland et al., 2014; Ritterband et al., 2011; J. Savard, Simard, Ivers, & Morin, 2005).”
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“Studies on fatigue in patients with cancer [23–28], chronic pain [29], chronic fatigue syndrome [30, 31], brain injury [32] and muscular diseases [33, 34], suggest that such psychological or psychosocial interventions are effective in reducing fatigue that is caused by multiple interacting factors.”
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“Being diagnosed with cancer can have a psychological impact on the patient and their family, and sleep is an important process that aids healing and is often linked to pain and stress (Espie et al, 2008).”
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“Although evidence obtained from studies that included participants with cancer [14, 15], renal failure [16], chronic pain [17], osteoarthritis, [18] and COPD [19, 20] support the notion that CBT-I is effective in reducing insomnia when coexisting with chronic illness, no studies to date have examined CBT-I specificall…”
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Drozd, C., Curtit, E., Jacquinot, Q., Marquine, C., Mansi, L., Chaigneau, L., Dobi, E., Viot, J., Meynard, G., Paillard, M., et al. (2023) · BMC Cancer · doi:10.1186/s12885-023-10902-6 · Cited by 12
“Its efficacy has been demonstrated in the specific context of cancer [50, 51].”
BackgroundSleep Quality in Head and Neck Cancer
Pecorari, G., Moglio, S., Gamba, D., Briguglio, M., Cravero, E., Baduel, E. S., & Riva, G. (2024) · Current Oncology · doi:10.3390/curroncol31110515 · Cited by 11
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“…cancer patients have shown that a significant quantity of women report sleep disturbances for months and years following diagnosis (Bower, 2008; Epstein and Dirksen, 2007; Espie et al., 2008; Lindley et al., 1998), indicating that insomnia may become a chronic condition in patients and survivors.”
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“After CBT-I, patients with cancer experienced significant improvements in insomnia severity; mood disturbance, such as depression and anxiety; cancer-related fatigue; and overall quality of life (Cannici, Malcolm, & Peek, 1983; Espie et al., 2008; Garland et al., 2014; Quesnel, Savard, Simard, Ivers, & Morin, 2003; Sa…”
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“The insomnia literature offers the most useful definitions [24, 29], measures [24, 32, 33] and criteria for improvement [32, 34, 35], so far absent from the tinnitus literature.”
BackgroundCognitive behavioral therapy for the management of poor sleep in insomnia disorder
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“CBT-I has demonstrated benefit in patients with insomnia and various common co-occurring conditions, including depression and other mental health disorders [37, 38], chronic pain [39–41], breast cancer [42, 43], and hypnotic dependence [44].”
Exercise Intervention on Insomnia in Patients with a Cancer: A Systematic Review of the Literature
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Fatigue as Mediator Factor in PTSD-Symptoms after Allogeneic Hematopoietic Stem Cell Transplantation
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Fatigue et troubles du sommeil chez les patients atteints de cancer colorectal
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Nonpharmacologic Approach to Sleep Disorders
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“There is some preliminary evidence that CBT may provide generalised benefits, as well as some exploratory data from small samples suggesting that CBT for patients with insomnia may reduce anxiety and depression symptoms.(40) 41 However, a sufficiently powered, well-planned trial examining the relationship between char…”
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PRO: CBT-I for insomnia treatment can be delivered by a range of healthcare providers
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BackgroundA Self-Administered Sleep Intervention for Patients With Cancer Experiencing Insomnia
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Metadata
- Authors
- Espie, C. A., Fleming, L., Cassidy, J., Samuel, L., Taylor, L. M., White, C. A., Douglas, N. J., Engleman, H. M., Kelly, H.-L., & Paul, J.
- Affiliations
- Beatson West of Scotland Cancer Centre (GB)
- Venue
- Journal of Clinical Oncology
- Published
- 2008-10-01
- Volume
- 26
- Issue
- 28
- Pages
- 4651-4658
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2132331779
- Cited by
- 383
- References
- 42
- Citations by year
- 2026: 6 · 2025: 16 · 2024: 16 · 2023: 14 · 2022: 20 · 2021: 22 · 2020: 19 · 2019: 22 · 2018: 20 · 2017: 21 · 2016: 29 · 2015: 28 · 2014: 35 · 2013: 21 · 2012: 28
- FWCI
- 29.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- Funders
- Cancer Research UK (C8265/A3036)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Keywords
- cognitive behavioral therapy, insomnia, cancer survivors, oncology nurses, usual care, sleep efficiency, health-related quality of life, daytime fatigue, psychopathology, breast cancer, prostate cancer, gynecologic cancer, colorectal cancer, sleep diary, actigraphy
- MeSH terms
- Adult, Aged, Aged, 80 and over, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Neoplasms, Psychometrics, Quality of Life, Cognitive Behavioral Therapy, Linear Models, Treatment Outcome
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