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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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“Interventions include cognitive–behavioral therapy and stress management techniques such as relaxation and mindfulness (e.g., Espie et al., 2008; Mann et al., 2012; Penedo et al., 2006; Piet, Würtzen, & Zachariae, 2012), psychoeducational approaches (e.g., Dolbeault et al., 2009; Marcus et al.,…”
BackgroundQuality of life in patients suffering from insomnia.
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BackgroundMindfulness‐based cognitive therapy reduces chronic cancer‐related fatigue: a treatment study
van der Lee, M. L., & Garssen, B. (2012) · Psycho-Oncology · doi:10.1002/pon.1890 · Cited by 178
“81) [60] and did less well than the individual CBT (effect size: 1.”
Tang, N. K. Y., Lereya, S. T., Boulton, H., Miller, M. A., Wolke, D., & Cappuccio, F. P. (2015) · Sleep · doi:10.5665/sleep.5158 · Cited by 176
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Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue
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Recommendations for High-Priority Research on Cancer-Related Fatigue in Children and Adults
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Palesh, O. G., Peppone, Innominato, Janelsins, Jeong, M., Sprod, L. K., Savard, J., Rotatori, R. M., Telli, Mustian, et al. (2012) · Nature and Science of Sleep · doi:10.2147/nss.s18895 · Cited by 167
“Of note, three out of four randomized controlled trials utilized group therapy rather than individual therapy, suggesting that group therapy is feasible and effective for survivors.(103,104,108) Studies in cancer survivors outnumber those in cancer patients undergoing treatment, most likely due to feasibility issues.”
Otte, J. L., Carpenter, J. S., Manchanda, S., Rand, K. L., Skaar, T. C., Weaver, M. T., Chernyak, Y., Zhong, X., Igega, C. M., & Landis, C. A. (2014) · Cancer Medicine · doi:10.1002/cam4.356 · Cited by 154
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MethodManagement of side effects during and post-treatment in breast cancer survivors
Palesh, O. G., Scheiber, C., Kesler, S. R., Mustian, K. M., Koopman, C., & Schapira, L. (2017) · The Breast Journal · doi:10.1111/tbj.12862 · Cited by 153
Understanding and Treating Insomnia
Bootzin, R. R., & Epstein, D. R. (2011) · Annual Review of Clinical Psychology · doi:10.1146/annurev.clinpsy.3.022806.091516 · Cited by 150
“Five studies use multicomponent interventions in a CBT-I approach (Davidson et al. 2001, Epstein & Dirksen 2007, Espie et al. 2008, Quesnel et al. 2003, Savard et al. 2005).”
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“Cancer diagnosis Lung 10 (23) 15 (35) 25 (29) Prostate 6 (14) 9 (21) 15 (17) Colorectal 6 (14) 4 (9) 10 (12) Gynecologic 21 (49) 15 (35) 36 (42)”
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“Four RCTs and a recent systematic review provide continued evidence that cognitive-behavioral interventions for sleep delivered individually, in a group setting, or via the Internet also produce beneficial effects on CRF outcomes (Dirksen & Epstein, 2008; Espie et al., 2008; Fleming, Randell, Harvey, & Espie, 2014; Ga…”
Sleep problems in breast cancer survivors 1–10 years posttreatment
Lowery-Allison, A. E., Passik, S. D., Cribbet, M. R., Reinsel, R. A., O'Sullivan, B., Norton, L., Kirsh, K. L., & Kavey, N. B. (2018) · Palliative and Supportive Care · doi:10.1017/s1478951517000311 · Cited by 125
“Engaging in a sleep-improvement intervention has the potential to enhance breast cancer survivors’ QoL, reduce physical symptoms, improve mood (Berger et al., 2009a; Espie et al., 2008; Savard et al., 2005), and even affect the disease course and survival (Palesh et al.”
BackgroundLengacher, C. A., Reich, R. R., Paterson, C. L., Jim, H. S., Ramesar, S., Alinat, C. B., Budhrani, P. H., Farias, J. R., Shelton, M. M., Moscoso, M. S., et al. (2015) · Psycho-Oncology · doi:10.1002/pon.3603 · Cited by 119
“Although cognitive behavioral therapy for insomnia is considered the gold standard nonpharmacological treatment for insomnia, it may not target the increased psychological distress and fears of recurrence among cancer survivors [8,16,17].”
BackgroundSleep Disruption in Breast Cancer Patients and Survivors
Palesh, O. G., Aldridge-Gerry, A. A., Ulusakarya, A., Ortiz‐Tudela, E., Capuron, L., & Innominato, P. F. (2013) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2013.0179 · Cited by 122
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Sleep problems in cancer patients: prevalence and association with distress and pain
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Exercise interventions to improve sleep in cancer patients: a systematic review and meta-analysis
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Anxiety and sleep disorders in cancer patients
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Zhou, E. S., Partridge, A. H., Syrjala, K. L., Michaud, A. L., & Recklitis, C. J. (2016) · Journal of Cancer Survivorship · doi:10.1007/s11764-016-0564-1 · Cited by 105
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“, 2009) and other cancer populations (Espie et al., 2008; Rumble, Keefe, Edinger, Porter, & Garst, 2005).”
as the Sleep Disturbance Expert Panel on behalf of the Cancer Journey Advisory Group of the Canadian Partnership Against Cancer, Howell, D., Oliver, T. K., Keller-Olaman, S., Davidson, J. R., Garland, S. N., Samuels, C. H., Savard, J., Harris, C. A., Aubin, M., et al. (2013) · Supportive Care in Cancer · doi:10.1007/s00520-013-1823-6 · Cited by 100
“Eight of the 12 trials used cognitive behavioral therapies as the intervention [22,23,25–28,30,31].”
BackgroundImproving sleep quality for cancer patients: benefits of a home-based exercise intervention
Tang, M.-F., Liou, T., & Lin, C. (2009) · Supportive Care in Cancer · doi:10.1007/s00520-009-0757-5 · Cited by 102
“Patients with cancer often report that their sleep is disturbed during the stressful periods associated with diagnosis, treatment side effects, and physical discomfort [1].”
BackgroundRichardson, A. M., Addington-Hall, J. M., Amir, Z., Foster, C. L., Stark, D., Armes, J., Brearley, S. G., Hodges, L., Hook, J., Jarrett, N., et al. (2011) · British Journal of Cancer · doi:10.1038/bjc.2011.425 · Cited by 98
Corbett, T. K., Groarke, A., Devane, D., Carr, E., Walsh, J. C., & McGuire, B. E. (2019) · Systematic Reviews · doi:10.1186/s13643-019-1230-2 · Cited by 97
“Espie 2008 [23] FSI 150 100 50 6 months p 0.001 (Standardized Effect =− 0.82) CBT participants had reduced symptoms of fatigue relative to TAU.”
BackgroundInfluentialPatient‐reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy
Kidwell, K., Harte, S. E., Hayes, D. F., Storniolo, A. M., Carpenter, J. S., Flockhart, D. A., Stearns, V., Clauw, D. J., Williams, D. A., & Henry, N. L. (2014) · Cancer · doi:10.1002/cncr.28756 · Cited by 98
Fleming, L., Randell, K., Harvey, C., & Espie, C. A. (2014) · Psycho-Oncology · doi:10.1002/pon.3468 · Cited by 100
Sleep quality after initial chemotherapy for breast cancer
Beck, S. L., Berger, A. M., Barsevick, A. M., Wong, B. G., Stewart, K. A., & Dudley, W. N. (2009) · Supportive Care in Cancer · doi:10.1007/s00520-009-0662-y · Cited by 96
“This finding supports other research that indicates that the commonly accepted subjective indicator of poor sleep quality (PSQI scores ≥5 or 8) is measuring perceptions that complement, but are not consistently correlated with objective measures in either the general population [39] or in cancer patients [40].”
Harvey, A. G., Dong, L., Hein, K., Yu, S. H., Martinez, A. J., Gumport, N. B., Smith, F. L., Chapman, A., Lisman, M., Mirzadegan, I. A., et al. (2021) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000650 · Cited by 108
“effect for the average effect size across outcomes based on prior literature (15, 16, 39), a significance of 0.”
BackgroundThe Fatigue Symptom Inventory: a systematic review of its psychometric properties
Donovan, K. A., & Jacobsen, P. B. (2011) · Supportive Care in Cancer · doi:10.1007/s00520-010-0989-4 · Cited by 94
“Five studies reported results in the context of nonpharmacological interventions designed to ameliorate symptoms that included fatigue [15, 22, 30, 51, 74].”
MethodResultInsomnia in adult patients with cancer: ESMO Clinical Practice Guideline
Grassi, L., Zachariae, R., Caruso, R., Palagini, L., Campos-Ródenas, R., Riba, M. B., Lloyd-Williams, M., Kissane, D., Rodin, G., McFarland, D., et al. (2023) · ESMO Open · doi:10.1016/j.esmoop.2023.102047 · Cited by 96
Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT)
McGrath, E. R., Espie, C. A., Power, A., Murphy, A. W., Newell, J., Kelly, C., Duffy, N., Gunning, P., Gibson, I., Bostock, S., et al. (2016) · American Journal of Hypertension · doi:10.1093/ajh/hpw132 · Cited by 88
Squires, L. R., Rash, J. A., Fawcett, J., & Garland, S. N. (2022) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2022.101615 · Cited by 85
Kim, J., Park, E., Yoo, K., & Park, S. (2015) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.4772 · Cited by 87
Cancer-Related Fatigue: The Approach and Treatment
Escalante, C. P., & Manzullo, E. F. (2009) · Journal of General Internal Medicine · doi:10.1007/s11606-009-1056-z · Cited by 87
Kapella, M. C., Herdegen, Perlis, Shaver, Larson, J. L., Law, & Carley (2011) · International Journal of COPD · doi:10.2147/copd.s24858 · Cited by 86
“The observation of reduced fatigue is in accordance with Espie and colleagues, who reported significant reductions in fatigue after CBT-I in cancer patients.(16) Clearly, issues of fatigue measurement are complex.”
Langford, D. J., Lee, K. A., & Miaskowski, C. A. (2011) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2011.07.002 · Cited by 84
The development and impact of insomnia on cancer survivors: a qualitative analysis
Fleming, L., Gillespie, S., & Espie, C. A. (2009) · Psycho-Oncology · doi:10.1002/pon.1652 · Cited by 83
Insomnia in breast cancer: a prospective observational study
Fleming, L., Randell, K., Stewart, E., Espie, C. A., Morrison, D. S., Lawless, C., & Paul, J. (2018) · SLEEP · doi:10.1093/sleep/zsy245 · Cited by 86
Survivorship Services for Adult Cancer Populations: A Pan-Canadian Guideline
Howell, D., Hack, T. F., Oliver, T. K., Chulak, T., Mayo, S. J., Aubin, M., Chasen, M. R., Earle, C. C., Friedman, A. J., Green, E., et al. (2011) · Current Oncology · doi:10.3747/co.v18i6.956 · Cited by 85
Recognition and Treatment of Sleep Disturbances in Cancer
Ancoli‐Israel, S. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.24.5993 · Cited by 81
Heckler, C. E., Garland, S. N., Peoples, A. R., Perlis, M. L., Shayne, M., Morrow, G. R., Kamen, C. S., Hoefler, J., & Roscoe, J. A. (2015) · Supportive Care in Cancer · doi:10.1007/s00520-015-2996-y · Cited by 83
“In three previous randomized controlled trials (RCTs) of CBT-I in cancer, two reported improvements in both insomnia and fatigue [18, 22], while the other improved insomnia only [23].”
BackgroundSleep as a public health concern: insomnia and mental health
Robotham, D. (2011) · Journal of Public Mental Health · doi:10.1108/17465721111188250 · Cited by 79
The effect of sleep disturbance on quality of life in women with ovarian cancer
Sandadi, S., Frasure, H. E., Broderick, M. J., Waggoner, S. E., Miller, J. M., & von Gruenigen, V. E. (2011) · Gynecologic Oncology · doi:10.1016/j.ygyno.2011.07.028 · Cited by 79
Thomas, K. S., Bower, J. E., Hoyt, M. A., & Sepah, S. (2009) · Psycho-Oncology · doi:10.1002/pon.1639 · Cited by 78
“Several studies have demonstrated that cognitive and behavioral techniques are effective in treating insomnia in cancer patients [26,41,45–47].”
BackgroundSun, J., Chiou, J.-F., & Lin, C. (2011) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2010.07.021 · Cited by 78
Barton, D. L., Atherton, P. J., Bauer, B. A., Moore, D. F., Mattar, B. I., Lavasseur, B. I., Rowland, K. M., Zon, R. T., Le-Lindqwister, N. A., Nagargoje, G. G., et al. (2011) · The Journal of Supportive Oncology · doi:10.1016/j.suponc.2010.12.008 · Cited by 79
Savard, J., Ivers, H., Savard, M., Morin, C. M., Caplette‐Gingras, A., Bouchard, S., & Lacroix, G. (2021) · SLEEP · doi:10.1093/sleep/zsab166 · Cited by 80
“This is the first randomized controlled trial on the effects of a stepped care CBT-I, although this approach has been recommended for at least a decade now as a cost-effective way to increase patient’s access to this treatment [47].”
BackgroundFiorentino, L., McQuaid, Liu, Natarajan, He, Cornejo, Lawton, Parker, Sadler, Ancoli‐Israel, S., et al. (2009) · Nature and Science of Sleep · doi:10.2147/nss.s8004 · Cited by 72
Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors
Peoples, A. R., Garland, S. N., Pigeon, W. R., Perlis, M. L., Wolf, J. R., Heffner, K. L., Mustian, K. M., Heckler, C. E., Peppone, L. J., Kamen, C. S., et al. (2019) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.7586 · Cited by 75
“These findings are consistent with previous studies that have also shown a secondary benefit of CBT-I on reducing depression in cancer survivors in addition to ameliorating subjective sleep difficul - ties 22–24 and that treatment benefits were sustained over time.”
Prostate cancer treatments and their side effects are associated with increased insomnia
Savard, J., Hervouet, S., & Ivers, H. (2012) · Psycho-Oncology · doi:10.1002/pon.3150 · Cited by 71
“for cancer-related insomnia has received increased empirical support [31,32], although not specifically in prostate cancer patients.”
BackgroundAlfano, C. M., Lichstein, K. L., Wal, G. S. V., Smith, A. W., Reeve, B. B., McTiernan, A., Bernstein, L., Baumgartner, K. B., & Ballard-Barbash, R. R. (2011) · Breast Cancer Research and Treatment · doi:10.1007/s10549-011-1530-2 · Cited by 70
Studying Cancer-Related Fatigue: Report of the NCCN Scientific Research Committee
Mortimer, J. E., Barsevick, A. M., Bennett, C. L., Berger, A. M., Cleeland, C. S., DeVader, S. R., Escalante, C. P., Gilreath, J. A., Hurria, A., Mendoza, T. R., et al. (2010) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2010.0101 · Cited by 73
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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