SleepNow – A combined cognitive behavioral therapy for insomnia and physical exercise intervention in men with metastatic prostate cancer: results from a feasibility randomized controlled trial
DOI:
https://doi.org/10.2340/1651-226X.2025.42246Keywords:
insomnia, exercise, metastatic cancer, cognitive behavioral therapy, prostate cancerAbstract
focused on patients living with metastatic cancer. We examined the feasibility of the SleepNow intervention combining cognitive behavioral therapy for insomnia (CBT-I) with physical exercise in men with metastatic prostate cancer (mPCa).
Patients/material and methods: We conducted a feasibility randomized trial in patients under treatment for castration resistant mPCa with insomnia (Insomnia Severity Index [ISI] score ≥ 8). Patients were randomized 1:1 to either SleepNow or usual care. SleepNow is a manualized 12-week program consisting of bi-weekly sessions of physical exercise and four nurse-led sessions of CBT-I. Patients in usual care received no insomnia treatment. We assessed feasibility and measured objective and patient-reported outcomes at baseline and 3-months follow-up. Changes in both groups were compared using the Wilcoxon test.
Results: We randomized 12 patients (5 intervention and 7 control; age range = 59–81 years, mean Gleason score = 7.75, mean time since diagnosis ≈ 7 years). Intervention patients reported high satisfaction, all attended at least three CBT-I sessions (75%) and four completed at least 20 of the 24 training sessions. The intervention group showed improvements in insomnia, sleep quality, fatigue, anxiety, depression and health-related quality-of-life but between-group differences were not statistically significant.
Interpretation: The SleepNow intervention is the first to combine nurse-delivered CBT-I and physical exercise and was acceptable and potentially efficacious. Our results are important for targeting sleep interventions to the growing population of patients living long term with metastatic cancer.
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References
Nzwalo I, Aboim MA, Joaquim N, Marreiros A, Nzwalo H. Systematic review of the prevalence, predictors, and treatment of insomnia in palliative care. Am J Hosp Palliat Care. 2020;37(11):957–69.
https://doi.org/10.1177/1049909120907021 DOI: https://doi.org/10.1177/1049909120907021
Büttner-Teleagă A, Kim YT, Osel T, Richter K. Sleep disorders in cancer – A systematic review. Int J Environ Res Public Health. 2021;18(21):11696.
https://doi.org/10.3390/ijerph182111696 DOI: https://doi.org/10.3390/ijerph182111696
Wright KP Jr., Drake AL, Frey DJ, Fleshner M, Desouza CA, Gronfier C, et al. Influence of sleep deprivation and circadian misalignment on cortisol, inflammatory markers, and cytokine balance. Brain Behav Immun. 2015;47:24–34.
https://doi.org/10.1016/j.bbi.2015.01.004 DOI: https://doi.org/10.1016/j.bbi.2015.01.004
Koren D, Taveras EM. Association of sleep disturbances with obesity, insulin resistance and the metabolic syndrome. Metabolism. 2018;84:67–75.
https://doi.org/10.1016/j.metabol.2018.04.001 DOI: https://doi.org/10.1016/j.metabol.2018.04.001
Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011;29(26):3580–6.
https://doi.org/10.1200/JCO.2010.33.2247 DOI: https://doi.org/10.1200/JCO.2010.33.2247
Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001;19(3):895–908.
https://doi.org/10.1200/JCO.2001.19.3.895 DOI: https://doi.org/10.1200/JCO.2001.19.3.895
Shechter A, Boivin DB. Sleep, hormones, and circadian rhythms throughout the menstrual cycle in healthy women and women with pre-menstrual dysphoric disorder. Int J Endocrinol. 2010;2010:259345.
https://doi.org/10.1155/2010/259345 DOI: https://doi.org/10.1155/2010/259345
Mangar S, Abbadasari M, Carollo A, Esposito G, Ahmed H, Shah T, et al. Understanding sleep disturbances in prostate cancer – a scien-tometric analysis of sleep assessment, aetiology, and its impact on quality of life. Cancers (Basel). 2023;15(13):3485.
https://doi.org/10.3390/cancers15133485 DOI: https://doi.org/10.3390/cancers15133485
Savard J, Ivers H, Savard MH, Morin CM. Cancer treatments and their side effects are associated with aggravation of insomnia: results of a longitudinal study. Cancer. 2015;121(10):1703–1711.
https://doi.org/10.1002/cncr.29244 DOI: https://doi.org/10.1002/cncr.29244
Sparasci D, Napoli I, Rossi L, Pereira-Mestre R, Manconi M, Treglia G, et al. Prostate cancer and sleep disorders: a systematic review. Cancers (Basel). 2022;14(7).
https://doi.org/10.3390/cancers14071784 DOI: https://doi.org/10.3390/cancers14071784
Lie JD, Tu KN, Shen DD, Wong BM. Pharmacological treatment of insomnia. P T. 2015;40(11):759–71.
Grassi L, Zachariae R, Caruso R, Palagini L, Campos-Ródenas R, Riba MB, et al. Insomnia in adult patients with cancer: ESMO Clinical Practice Guideline. ESMO Open. 2023;8(6):102047.
https://doi.org/10.1016/j.esmoop.2023.102047 DOI: https://doi.org/10.1016/j.esmoop.2023.102047
Plinsinga ML, Singh B, Rose GL, Clifford B, Bailey TG, Spence RR, et al. The effect of exercise on pain in people with cancer: a systematic review with meta-analysis. Sports Med. 2023;53(9):1737–52.
https://doi.org/10.1007/s40279-023-01862-9 DOI: https://doi.org/10.1007/s40279-023-01862-9
Ben S, Timothy O, Rachel C, Dorothea D, Rosa V, Amanda W, et al. Effectiveness of physical activity interventions for improving depression, anxiety and distress: an overview of systematic reviews. Br J Sports Med. 2023;57(18):1203.
https://doi.org/10.1136/bjsports-2022-106195 DOI: https://doi.org/10.1136/bjsports-2022-106195
Melancon MO, Lorrain D, Dionne IJ. Exercise and sleep in aging: emphasis on serotonin. Pathol Biol (Paris). 2014;62(5):276–83.
https://doi.org/10.1016/j.patbio.2014.07.004 DOI: https://doi.org/10.1016/j.patbio.2014.07.004
Fang YY, Hung CT, Chan JC, Huang SM, Lee YH. Meta-analysis: exercise intervention for sleep problems in cancer patients. Eur J Cancer Care (Engl). 2019;28(5):e13131.
https://doi.org/10.1111/ecc.13131 DOI: https://doi.org/10.1111/ecc.13131
Johnson JA, Rash JA, Campbell TS, Savard J, Gehrman PR, Perlis M, et al. A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Med Rev. 2016;27:20–8.
https://doi.org/10.1016/j.smrv.2015.07.001 DOI: https://doi.org/10.1016/j.smrv.2015.07.001
Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018;8(9):e022233.
https://doi.org/10.1136/bmjopen-2018-022233 DOI: https://doi.org/10.1136/bmjopen-2018-022233
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.
https://doi.org/10.1136/bmj.i5239 DOI: https://doi.org/10.1136/bmj.i5239
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–91.
https://doi.org/10.1002/pst.185 DOI: https://doi.org/10.1002/pst.185
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005;23(25):6083–96.
https://doi.org/10.1200/JCO.2005.09.548 DOI: https://doi.org/10.1200/JCO.2005.09.548
Andersen LB. A maximal cycle exercise protocol to predict maximal oxygen uptake. Scand J Med Sci Sports. 1995;5(3):143–6.
https://doi.org/10.1111/j.1600-0838.1995.tb00027.x DOI: https://doi.org/10.1111/j.1600-0838.1995.tb00027.x
Squires LR, Rash JA, Fawcett J, Garland SN. Systematic review and meta-analysis of cognitive-behavioural therapy for insomnia on subjec-tive and actigraphy-measured sleep and comorbid symptoms in cancer survivors. Sleep Med Rev. 2022;63:101615.
https://doi.org/10.1016/j.smrv.2022.101615 DOI: https://doi.org/10.1016/j.smrv.2022.101615
Rezaie L, Fobian AD, McCall WV, Khazaie H. Paradoxical insomnia and subjective-objective sleep discrepancy: a review. Sleep Med Rev. 2018;40:196–202.
https://doi.org/10.1016/j.smrv.2018.01.002 DOI: https://doi.org/10.1016/j.smrv.2018.01.002
Shen B, Ma C, Wu G, Liu H, Chen L, Yang G. Effects of exercise on circadian rhythms in humans. Front Pharmacol. 2023;14:1282357.
https://doi.org/10.3389/fphar.2023.1282357 DOI: https://doi.org/10.3389/fphar.2023.1282357
Savard J, Ivers H, Morin CM, Lacroix G. Video cognitive-behavioral therapy for insomnia in cancer patients: a cost-effective alternative. Psychooncology. 2021;30(1):44–51.
https://doi.org/10.1002/pon.5532 DOI: https://doi.org/10.1002/pon.5532
Zachariae R, Lyby MS, Ritterband LM, O’Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia – a systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016;30:1–10.
https://doi.org/10.1016/j.smrv.2015.10.004 DOI: https://doi.org/10.1016/j.smrv.2015.10.004
Horsch C, Spruit S, Lancee J, van Eijk R, Beun RJ, Neerincx M, et al. Reminders make people adhere better to a self-help sleep intervention. Health Technol (Berlin). 2017;7(2):173–88.
https://doi.org/10.1007/s12553-016-0167-x DOI: https://doi.org/10.1007/s12553-016-0167-x
Muench A, Vargas I, Grandner MA, Ellis JG, Posner D, Bastien CH, et al. We know CBT-I works, now what? Fac Rev. 2022;11:4.
https://doi.org/10.12703/r/11-4 DOI: https://doi.org/10.12703/r/11-4
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Copyright (c) 2025 Beverley Lim Høeg, Katrine Bjerre Løppenthin, Josée Savard, Christoffer Johansen, Jesper Frank Christensen, Mads Nordahl Svendsen, Niels Holländer, Pernille Envold Bidstrup
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