Cognitive behavioural therapy for insomnia in people with cancer
- PMID: 41170811
- PMCID: PMC12576927
- DOI: 10.1002/14651858.CD015176.pub2
Cognitive behavioural therapy for insomnia in people with cancer
Abstract
Background: Insomnia is a prevalent and distressing issue for individuals with cancer, negatively impacting their overall well-being. While cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia in the general population, its effects on cancer populations warrant rigorous, ongoing evaluation. Previous meta-analyses assessing CBT-I against specific comparators in people with cancer have often exhibited methodological limitations. Furthermore, with a recent increase in randomised controlled trials (RCTs) in this field, an updated and comprehensive synthesis is necessary.
Objectives: To assess the effects of cognitive behavioural therapy for insomnia (CBT-I) in people with cancer.
Search methods: In April 2025, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and clinical trials registries. We also checked reference lists. We applied no language, publication date, or study setting restrictions.
Selection criteria: We included all RCTs that compared the effects of CBT-I with other treatments in individuals diagnosed with both insomnia and cancer. We placed no restrictions on the specific characteristics of the CBT-I interventions or the comparator groups. We excluded quasi-randomised and cross-over trials.
Data collection and analysis: We used random-effects meta-analysis for our primary analyses. Our critical outcomes were: insomnia severity (Insomnia Severity Index (ISI), range 0 to 28), sleep quality (Pittsburgh Sleep Quality Index (PSQI), range 0 to 21), and serious adverse events (SAEs). Important outcomes were sleep diary-derived parameters: sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE). We also analysed objective sleep parameters for the comparisons presented in the summary of findings (SoF) tables. We used the Cochrane risk of bias 2 (RoB 2) tool to assess risk of bias and the GRADE approach to assess evidence certainty. We interpreted findings for continuous outcomes against minimally important differences (MIDs).
Main results: We included 21 RCTs (2431 randomised participants, predominantly female adults). Participants had received treatment for a range of cancer types, with breast cancer being the most frequently studied, and most were cancer survivors undergoing or following cancer treatment. CBT-I was typically delivered via therapist-led sessions or digital programs (four to 12 weeks). We identified five comparisons and summarised the findings for the two primary comparisons, with outcomes assessed at the conclusion of CBT-I treatment. The risk of bias was often high. Overall, CBT-I may offer small subjective improvements in insomnia for cancer survivors, and the evidence certainty was mostly low to very low. Benefits on objective measures are less clear. CBT-I versus inactive control Compared to inactive control post-intervention, CBT-I may slightly reduce ISI scores (mean difference (MD) -5.86 points, 95% confidence interval (CI) -7.22 to -4.51; 14 studies, 1371 participants; very low-certainty evidence) and PSQI scores (MD -3.60 points, 95% CI -4.95 to -2.24; 3 studies, 473 participants; low-certainty evidence). CBT-I may result in little to no difference in the occurrence of SAEs (risk ratio (RR) 1.05, 95% CI 0.07 to 16.77; 4 studies, 765 participants; very low-certainty evidence). Regarding sleep diary outcomes, CBT-I probably reduces SOL (MD -13.35 min, 95% CI -17.18 to -9.51; 9 studies, 760 participants; moderate-certainty evidence), may reduce WASO (MD -15.39 min, 95% CI -25.23 to -5.56; 9 studies, 784 participants; very low-certainty evidence), and may improve SE very slightly (MD 7.84%, 95% CI 3.62 to 12.06; 9 studies, 725 participants; very low-certainty evidence). CBT-I may result in little to no difference in TST (MD 6.43 min, 95% CI -8.30 to 21.16; 10 studies, 899 participants; very low-certainty evidence). Regarding objective sleep outcomes, CBT-I may result in little to no difference in SOL (MD -4.54 min, 95% CI -9.91 to 0.84; 2 studies, 129 participants), WASO (MD -5.08 min, 95% CI -10.62 to 0.46; 3 studies, 242 participants), TST (MD -11.01 min, 95% CI -29.35 to 7.33; 4 studies, 521 participants), and SE (MD 1.35%, 95% CI 0.08 to 2.63; 5 studies, 571 participants). CBT-I versus aerobic activities Compared to aerobic activities post-intervention, CBT-I may reduce ISI scores (MD -3.53 points, 95% CI -4.43 to -2.62; 2 studies, 406 participants; low-certainty evidence) and PSQI scores (MD -1.67 points, 95% CI -2.63 to -0.72; 3 studies, 496 participants; low-certainty evidence). CBT-I may result in little to no difference in the occurrence of SAEs (RR 0.35, 95% CI 0.04 to 3.36; 2 studies, 579 participants; very low-certainty evidence). Regarding sleep diary outcomes, CBT-I may result in little to no difference in SOL (MD -6.15 min, 95% CI -13.07 to 0.78; 2 studies, 131 participants; low-certainty evidence), WASO (MD -6.35 min, 95% CI -15.30 to 2.61; 2 studies, 131 participants; low-certainty evidence), and TST (MD 0.40 min, 95% CI -21.10 to 21.90; 2 studies, 131 participants; very low-certainty evidence). However, CBT-I may slightly increase SE (MD 4.24%, 95% CI 0.45 to 8.02; 2 studies, 131 participants; low-certainty evidence). Regarding objective sleep outcomes, CBT-I may result in little to no difference in SOL (MD 6.07 min, 95% CI -1.47 to 13.62; 2 studies, 131 participants), WASO (MD 6.16 min, 95% CI -3.80 to 16.11; 2 studies, 131 participants), and SE (MD -0.90%, 95% CI -2.84 to 1.04; 3 studies, 416 participants), and may lead to shorter TST (MD -13.02 min, 95% CI -25.00 to -1.04; 3 studies, 416 participants).
Authors' conclusions: This Cochrane review found very low-certainty to moderate-certainty evidence suggesting that CBT-I may offer small to very small improvements in patient-reported insomnia severity, sleep quality, and most subjective sleep diary parameters when compared with inactive controls. Against aerobic activities, low-certainty evidence indicates that CBT-I may also improve insomnia severity and sleep quality. The incidence of SAEs appeared similar between CBT-I and comparator groups, and the certainty of this evidence is very low. The decision to use CBT-I to treat insomnia in people with cancer might depend on the treatment's availability and cost, as well as clinicians' and patients' preferences. Future research requires long-term, larger, and more rigorously designed studies that are inclusive and diverse.
Trial registration: ClinicalTrials.gov NCT04898855 NCT00134108 NCT01335776 NCT02356575 NCT04026048 NCT04566068 NCT00690196 NCT00672217 NCT02774369 NCT02613364 NCT04101526 NCT01091974 NCT00674830 NCT05233800 NCT02121652 NCT03810365 NCT02609880 NCT02002533 NCT01011218 NCT04829539 NCT02165839 NCT02444026 NCT01019187 NCT01929720 NCT02272712 NCT02410564 NCT05813392 NCT05887297 NCT05816460.
Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Cai Z: none known
Tang Y: none known
Liu C: none known
Li H: none known
Zhao G: none known
Zhao Z: none known
Zhang B: none known
Update of
- doi: 10.1002/14651858.CD015176
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- Van der Hoek H, Peersmann SH, Maurice-Stam H, Kaspers GJ, Van den Bergh EM, Tissing WJ, et al. The effect of online cognitive behavioral therapy for insomnia in adolescents and young adults after childhood cancer: results from a randomized controlled trial. Cancer 2025;131(6):e35796. [DOI: 10.1002/cncr.35796] - DOI
References to studies excluded from this review
Berger 2009 {published data only}
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- Berger AM, Kuhn BR, Farr LA, Lynch JC, Agrawal S, Chamberlain J, et al. Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psycho-oncology 2009;18(6):634-46. [DOI: 10.1002/pon.1438] - DOI
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- Berger AM, Kuhn BR, Farr LA, Von Essen SG, Chamberlain J, Lynch JC, et al. One-year outcomes of a behavioral therapy intervention trial on sleep quality and cancer-related fatigue. Journal of Clinical Oncology 2009;27(35):6033-40. [DOI: 10.1200/JCO.2008.20.8306] - DOI
Chung 2022 {published data only}ISRCTN11480833
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- Chung KM, Suh YJ, Chin S, Seo D, Yu ES, Lee HJ, et al. A pilot study testing the efficacy of dCBT in patients with cancer experiencing sleep problems. Frontiers in Psychology 2022;13:699168. [DOI: 10.3389/fpsyg.2022.699168] - DOI
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- ISRCTN11480833. App-based cognitive behavioral therapy for sleep problems in cancer patients. https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN11480833 (first received 12 February 2020).
Dean 2020 {published data only}
-
- Dean GE, Ferreira Da Rosa Silva C, Jungquist CR, Klimpt ML, Dickerson SS. Nurse-delivered brief behavioral therapy-insomnia for lung cancer survivors. Sleep 2017;40:A138. [DOI: 10.1093/sleepj/zsx050.371] - DOI
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- Dean GE, Weiss C, Jungquist CR, Klimpt ML, Alameri R, Ziegler PA, et al. Nurse-delivered brief behavioral treatment for insomnia in lung cancer survivors: a pilot RCT. Behavioral Sleep Medicine 2020;18(6):774-86. [DOI: 10.1080/15402002.2019.1685523] - DOI
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- Ferreira da Rosa Silva C, Klimpf ML, Demey Zambrano JA, Kulu SL, Jungquist CR, Dhillon S, et al. Nurse-delivered insomnia treatment in lung cancer survivors: pilot study to improve sleep, mood and quality of life. Sleep 2015;38:A307.
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- NCT02121652. Cognitive behavioral therapy (CBT)-insomnia for lung cancer. https://clinicaltrials.gov/show/NCT02121652 (first received 25 October 2013).
Dickerson 2024 {unpublished data only}
-
- Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. Journal of Cancer Survivorship 2024 Nov 26 [Epub ahead of print]. [DOI: 10.1007/s11764-024-01704-1] - DOI
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- Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: study protocol for a randomized-controlled trial. Contemporary Clinical Trials 2022;122:106939. [DOI: 10.1016/j.cct.2022.106939] - DOI
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- Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Annals of Behavioral Medicine 2025;59(1):kaae096.
-
- NCT03810365. Brief behavioral treatment for insomnia in cancer survivors. https://clinicaltrials.gov/show/NCT03810365 (first received 14 January 2019).
Fiorentino 2008 {published and unpublished data}
-
- Fiorentino L, McQuaid JR, Liu L, Natarajan L, He F, Cornejo M, et al. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Nature and Science of Sleep 2010;2:1-8. [DOI: 10.2147/nss.s8004] - DOI
-
- Fiorentino L. Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Crossover Study [Doctoral Thesis]. San Diego: University of California, 2008.
Padron 2022 {published data only}
-
- Hanvey GA, Padron A, Kacel EL, Cartagena G, Bacharz KC, McCrae CS, et al. Accrual and retention of diverse patients in psychosocial cancer clinical trials. Journal of Clinical and Translational Science 2022;6(1):e45. [DOI: 10.1017/cts.2022.380] - DOI
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- Kirsch JL, Robinson ME, McCrae CS, Kacel EL, Wong SS, Patidar S, et al. Associations among sleep latency, subjective pain, and thermal pain sensitivity in gynecologic cancer. Pain Sensitivity in Gynecologic Cancer 2020;21(1):5-12. [DOI: 10.1093/pm/pny236] - DOI
-
- Kirsch JL. Effects of a Cognitive Behavioral Intervention on Rest-Activity Circadian Rhythms, Proinflammatory Cytokines, and Survival among Women with Gynecologic Malignancies [Doctoral Thesis]. University of Florida, 2021.
-
- NCT02609880. Cognitive behavioral effects on sleep, pain, and cytokines in gynecologic cancer. https://clinicaltrials.gov/show/NCT02609880 (first received 09 November 2015).
-
- Padron A, Cartagena G, McCrae CS, Robinson ME, Trinastic L, Postupack RA, et al. Cognitive behavioral effects on total wake time in women with gynecologic malignancies and insomnia. Supportive Care in Cancer 2018;26(2):S233. [DOI: 10.1007/s00520-018-4193-2] - DOI
Palesh 2018 {published data only}
-
- NCT02002533. Brief behavioral therapy in improving sleep disorders in patients with stage i-iii breast cancer undergoing chemotherapy. https://clinicaltrials.gov/show/NCT02002533 (first received 30 November 2013).
-
- Palesh O, Scheiber C, Kesler S, Gevirtz R, Heckler C, Guido JJ, et al. Secondary outcomes of a behavioral sleep intervention: a randomized clinical trial. Health Psychology 2019;38(3):196-205. [DOI: 10.1037/hea0000700] - DOI
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- Palesh O, Scheiber C, Kesler S, Janelsins MC, Guido JJ, Heckler C, et al. Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial. British Journal of Cancer 2018;119(3):274-81. [DOI: 10.1038/s41416-018-0154-2] - DOI
-
- Palesh O, Scheiber C, Selland B, Packer M, Kesler S, Janelsins M, et al. Phase II RCT of brief behavioral therapy for cancer-related insomnia (BBT-CI): effects on quality of life (QOL) and heart rate variability (HRV). Supportive Care in Cancer 2017;25(2):S52. [DOI: 10.1007/s00520-017-3704-x] - DOI
-
- Palesh O, Scheiber C, Tong B, Packer M, Kesler S, Janelsins MC, et al. RCT of brief behavioral therapy (BBT-CI) for cancer-related insomnia and circadian rhythm during chemotherapy in a community oncology setting (NCORP). Journal of Clinical Oncology 2017;35(15):10094. [DOI: 10.1200/JCO.2017.35.15_suppl.10094] - DOI
Palesh 2020 {published and unpublished data}
-
- NCT01011218. Management of insomnia in breast cancer patients. https://clinicaltrials.gov/show/NCT01011218 (first received 09 November 2009).
-
- Palesh O, Innominato P, Mustian K, Janelsins M, Neri E, Koopman C, et al. Brief behavioral therapy for insomnia (BBT-I) in breast cancer (BC) during chemotherapy: a randomized pilot study. Supportive Care in Cancer 2013;21:S279. [DOI: 10.1007/s00520-013-1798-3] - DOI
-
- Palesh O, Solomon N, Hofmeister E, Jo B, Shen H, Cassidy-Eagle E, et al. A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy: a pilot study. Sleep 2020;43(10):13. [DOI: 10.1093/sleep/zsaa070] - DOI
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- Palesh O. Management of sleep disturbances in cancer: behavioral interventions in insomnia. Psycho-oncology 2021;30(Suppl 1):15‐6. [DOI: 10.1002/pon.5637] - DOI
Palesh 2021 {published data only}
-
- NCT04829539. Comparing brief behavioral therapy (BBT-CI) and healthy eating education learning (HEAL) for cancer-related sleep problems while receiving chemotherapy. https://clinicaltrials.gov/show/NCT04829539 (first received 11 March 2021).
Woldeamanuel 2021 {published and unpublished data}
-
- NCT02165839. Brief behavioral intervention for insomnia during chemotherapy. https://clinicaltrials.gov/study/NCT02165839 (first received 18 June 2014).
-
- Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, et al. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: secondary analysis of a randomized clinical trial. Cancer 2021;127(23):4492-503. [DOI: 10.1002/cncr.33844] - DOI
Zachariae 2018 {published data only}
-
- Amidi A, Buskbjerg CR, Damholdt MF, Dahlgaard J, Thorndike FP, Ritterband L, et al. Changes in sleep following internet-delivered cognitive-behavioral therapy for insomnia in women treated for breast cancer: a 3-year follow-up assessment. Sleep Medicine 2022;96:35-41. [DOI: 10.1016/j.sleep.2022.04.020] - DOI
-
- Amidi A, Damholdt M, Dahlgaard J, Ritterband L, Zachariae R. A Danish language internet-delivered intervention for insomnia in cancer survivors: effects on cancer-related fatigue. Sleep 2017;40(Suppl 1):A376-A377. [DOI: 10.1093/sleepj/zsx050.1011] - DOI
-
- NCT02444026. Feasibility and efficacy of internet-delivered CBT for insomnia in a national cohort of Danish breast cancer survivors. https://clinicaltrials.gov/show/NCT02444026 (first received 10 December 2014).
-
- Zachariae R, Amidi A, Damholdt M, Clausen C, Dahlgaard J, Lord H, et al. A randomized controlled trial of internetdelivered cognitive-behavioral therapy for insomnia (ICBT-I) in women treated for breast cancer-effects on sleep characteristics, sleep quality, and fatigue. Psychosomatic Medicine 2018;80(3):A81. [DOI: 10.1097/PSY.0000000000000578] - DOI
-
- Zachariae R, Amidi A, Damholdt MF, Clausen CD, Dahlgaard J, Lord H, et al. Internet-delivered cognitive-behavioral therapy for insomnia in breast cancer survivors: a randomized controlled trial. Journal of the National Cancer Institute 2018;110(8):880-7. [DOI: 10.1093/jnci/djx293] - DOI
References to studies awaiting assessment
Ernster 2021 {published data only}
-
- Ernster AE, Padron A, McCrae CS, Robinson ME, Waxenberg LB, Antoni MH, et al. Effects of a cognitive behavioral intervention on salivary cortisol levels in post-operative gynecologic oncology population: a randomized control trial. Brain, Behavior, and Immunity 2021;98:16. [DOI: 10.1016/j.bbi.2021.08.065] - DOI
Myers 2025 {published data only}
-
- Myers JS, Humphrey-Sewell RE, Fowler LA, English D, Stickler R, Hooper D, et al. Sleep hygiene education, ReadiWatchTM actigraphy, and telehealth cognitive behavioral training for insomnia for people with prostate cancer. Oncology Nursing Forum 2025;52(2):E15-34. [DOI: 10.1188/25.ONF.E15-E34] - DOI
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- NCT05582759. Sleep hygiene education, ReadiWatchTM actigraphy, and telehealth cognitive behavioral training for insomnia effect, on symptom relief for men with prostate cancer receiving androgen deprivation therapy. https://clinicaltrials.gov/study/NCT05582759 (first received 17 October 2022).
NCT01019187 {published data only}
-
- NCT01019187. Cognitive behavioral therapy with or without armodafinil in treating cancer survivors with insomnia and fatigue after chemotherapy. https://clinicaltrials.gov/show/NCT01019187 (first received 24 November 2009).
NCT01929720 {published data only}
-
- NCT01929720. Cognitive-behavioral intervention for worry, uncertainty, and insomnia for cancer survivors. https://clinicaltrials.gov/show/NCT01929720 (first received 28 August 2013).
NCT02272712 {unpublished data only}
-
- NCT02272712. The effectiveness of online treatment for insomnia in cancer survivors. https://clinicaltrials.gov/show/NCT02272712 (first received 06 October 2014).
NCT02410564 {published data only}
-
- NCT02410564. CBT-I intervention for insomnia in newly diagnosed cancer patients. https://clinicaltrials.gov/show/NCT02410564 (first received 7 April 2015).
NCT03542604 {published data only}
-
- NCT03542604. Cancer, obesity/overweight and insomnia study. https://clinicaltrials.gov/show/NCT03542604 (first received 31 May 2018).
Zheng 2015 {published data only}
-
- Zheng X. Effects of cognitive behavioral therapy on insomnia patients undergoing chemotherapy after breast cancer surgery. Chinese Journal of Rural Medicine and Pharmacy 2015;22(21):14-5. [DOI: 10.3969/j.issn.1006-5180.2015.21.008] - DOI
References to ongoing studies
Bice 2024 {unpublished data only}
-
- Bice BL, Michaud AL, McCormick KG, Miklos EM, Descombes ID, Medeiros-Nancarrow C, et al. Sleep treatment education program for cancer survivors: protocol for an efficacy trial. JMIR Research Protocols 2024;13(101599504):e60762. [DOI: 10.2196/60762] - DOI
-
- NCT05519982. Sleep treatment education program-1 (STEP-1). https://clinicaltrials.gov/study/NCT05519982 (first received 29 August 2022).
ChiCTR2100048095 {unpublished data only}ChiCTR2100048095
-
- ChiCTR2100048095. Repetitive transcranial magnetic stimulation compared with cognitive behavioral therapy for the treatment of insomnia in cancer survivors: a non-inferiority randomized controlled trial. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100048095 (first received 30 June 2021).
ChiCTR2500096855 {unpublished data only}
-
- ChiCTR2500096855. DCBT-I for sleep disturbances in cancer pain patients: a online, two-arm, single-blind, parallel-group, single-center, randomized controlled clinical trial protocol. https://www.chictr.org.cn/showproj.html?proj=253241 (first received 7 February 2025).
Maccora 2022 {unpublished data only}ACTRN12620001133921
-
- ACTRN12620001133921. The sleep, cancer and rest (SleepCare) trial: a randomised, controlled trial of four treatments for sleep during chemotherapy. https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12620001133921 (first received 30 October 2020).
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- Maccora J, Garland SN, Ftanou M, Day D, White M, Lopez VA, et al. The sleep, cancer and rest (SleepCaRe) trial: rationale and design of a randomized, controlled trial of cognitive behavioral and bright light therapy for insomnia and fatigue in women with breast cancer receiving chemotherapy. Contemporary Clinical Trials 2022;120:106877. [DOI: 10.1016/j.cct.2022.106877] - DOI
NCT05813392 {unpublished data only}
-
- NCT05813392. Digital cognitive behavioral therapy for insomnia for chronic insomnia in breast cancer survivors. https://clinicaltrials.gov/study/NCT05813392 (first received 17 December 2022).
NCT05887297 {unpublished data only}
-
- NCT05887297. Impact of cognitive behavioural therapy for insomnia on endocrine therapy adherence. https://clinicaltrials.gov/study/NCT05887297 (first received 6 June 2023).
NCT06439420 {published data only}
-
- NCT06439420. CBT-I in primary brain tumor patients: phase iic randomized feasibility pilot trial. https://clinicaltrials.gov/study/NCT06439420 (first received 3 June 2024).
NCT06553235 {published data only}
-
- NCT06553235. RESET-BRAIN: rehabilitation of sleep and cognitive impairment in breast cancer survivors using an app-based intervention. https://clinicaltrials.gov/study/NCT06553235 (first received 14 August 2024).
NCT06807086 {unpublished data only}
-
- NCT06807086. Efficacy of synchronous, virtual cognitive behavioral therapy for insomnia across phases of cancer survivorship. https://clinicaltrials.gov/study/NCT06807086 (first received 4 February 2025).
Treacy 2024 {unpublished data only}
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- NCT05816460. The Sleepio After Cancer study (SACS). https://clinicaltrials.gov/study/NCT05816460 (first received 13 March 2023).
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- Treacy T, O'Meara Y, Galligan MC, Henry AL, Lensen SF, Higgins MJ, et al. The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Contemporary Clinical Trials 2024;136:107337. [DOI: 10.1016/j.cct.2023.107337] - DOI
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