Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol

Claire M Starling, Daniel Greenberg, Eric Zhou, Daniel Lewin, Allison S Morrow, Daniel Lieberman, Callen Shaw, Hannah Arem, Claire M Starling, Daniel Greenberg, Eric Zhou, Daniel Lewin, Allison S Morrow, Daniel Lieberman, Callen Shaw, Hannah Arem

Abstract

Background: Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30-50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS.

Methods: We will conduct a 6-week, randomized controlled trial with two arms. Intervention arm participants will receive a smart speaker device and will be asked to engage with the program daily, using a voice-activated speaker with an accompanying smart-phone app. Control participants will have access to a website with basic information about CBT-I, sleep, and breast cancer survivorship and will be asked to engage with the website as desired.

Discussion: Our primary outcome is the Insomnia Severity Index total score. Secondary outcomes include sleep diary outcomes (sleep efficiency, wake after sleep onset, sleep onset latency, total sleep time, and sleep quality). This study will provide evidence on a promising modality to deliver elements of CBT-I for BCS experiencing insomnia. Trial Registration ClinicalTrials.gov NCT05233800 Released 3/25/2022.

Keywords: Breast cancer; Cancer survivorship; Cognitive behavioral therapy; Insomnia; Voice-activated speaker.

Conflict of interest statement

Media Rez is a for-profit company that seeks to commercialize an eventual product based on this technology consistent with the Small Business Innovation Research program.

© 2022. The Author(s).

References

    1. Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019;69(5):363–385. doi: 10.3322/caac.21565.
    1. Liu L, Ancoli-Israel S. Sleep disturbances in cancer. Psychiatr Ann. 2008;38(9):627–634. doi: 10.3928/00485713-20080901-01.
    1. Davidson JR, MacLean AW, Brundage MD, Schulze K. Sleep disturbance in cancer patients. Soc Sci Med. 2002;54(9):1309–1321. doi: 10.1016/s0277-9536(01)00043-0.
    1. Palesh OG, Roscoe JA, Mustian KM, et al. Prevalence, demographics, and psychological associations of sleep disruption in patients with cancer: University of Rochester cancer center-community clinical oncology program. J Clin Oncol. 2010;28(2):292–298. doi: 10.1200/JCO.2009.22.5011.
    1. Bluethmann SM, Mariotto AB, Rowland JH. Anticipating the "Silver Tsunami": prevalence trajectories and comorbidity burden among older cancer survivors in the United States. Cancer Epidemiol Biomark Prev. 2016;25(7):1029–1036. doi: 10.1158/1055-9965.EPI-16-0133.
    1. O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6(Suppl 1D):S6–14. doi: 10.1016/s1098-3597(05)80002-x.
    1. Ancoli-Israel S. Recognition and treatment of sleep disturbances in cancer. J Clin Oncol. 2009;27(35):5864–5866. doi: 10.1200/JCO.2009.24.5993.
    1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Clinical guidelines committee of the American college of physicians. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American college of physicians. Ann Intern Med. 2016;165(2):125–33. doi: 10.7326/M15-2175.
    1. Denlinger CS, Sanft T, Baker KS, et al. Survivorship, version 2.2018, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2018;16(10):1216–1247. doi: 10.6004/jnccn.2018.0078.
    1. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American academy of sleep medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255–262. doi: 10.5664/jcsm.8986.P.
    1. Thomas A, Grandner M, Nowakowski S, Nesom G, Corbitt C, Perlis ML. Where are the behavioral sleep medicine providers and where are they needed? A geographic assessment. Behav Sleep Med. 2016;14(6):687–98. doi: 10.1080/15402002.2016.1173551.
    1. Ellis JG, Seed J, Bastien CH, Grandner MA. Is it time to get some SHUT-i? Ann Transl Med. 2017;5(16):336. doi: 10.21037/atm.2017.04.28.
    1. Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2012;21(7):695–705. doi: 10.1002/pon.1969.
    1. Espie CA, Kyle SD, Williams C, et al. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012;35(6):769–781. doi: 10.5665/sleep.1872.
    1. Zhou E, Suh A, Youn S, Chung S. Adapting cognitive-behavior therapy for insomnia in cancer patients. Sleep Med Res. 2017;8(2):51–61. doi: 10.17241/smr/207.00080.
    1. Zachariae R, Amidi A, Damholdt MF, Clausen CDR, Dahlgaard J, Lord H, Thorndike FP, Ritterband LM. Internet-delivered cognitive-behavioral therapy for insomnia in breast cancer survivors: a randomized controlled trial. J Natl Cancer Inst. 2018;110(8):880–887. doi: 10.1093/jnci/djx293.
    1. Dozeman E, Verdonck-de Leeuw IM, Savard J, van Straten A. Guided web-based intervention for insomnia targeting breast cancer patients: feasibility and effect. Internet Interv. 2017;19(9):1–6. doi: 10.1016/j.invent.2017.03.005.
    1. Ritterband LM, Thorndike FP, Gonder-Frederick LA, et al. Efficacy of an internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatr. 2009;66(7):692–698. doi: 10.1001/archgenpsychiatry.2009.66.
    1. 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. doi: 10.1016/j.smrv.2015.10.004.
    1. Hassoon A, Schrack J, Naiman D, Lansey D, Baig Y, Stearns V, Celentano D, Martin S, Appel L. Increasing physical activity amongst overweight and obese cancer survivors using an alexa-based intelligent agent for patient coaching: protocol for the physical activity by technology help (PATH) trial. JMIR Res Protoc. 2018;7(2):e27. doi: 10.2196/resprot.9096.
    1. Steinberg D, Kay M, Burroughs J, Svetkey LP, Bennett GG. The effect of a digital behavioral weight loss intervention on adherence to the dietary approaches to stop hypertension (DASH) dietary pattern in medically vulnerable primary care patients: results from a randomized controlled trial. J Acad Nutr Diet. 2019;119(4):574–584. doi: 10.1016/j.jand.2018.12.011.
    1. Militello L, Sezgin E, Huang Y, Lin S. Delivering perinatal health information via a voice interactive app (SMILE): mixed methods feasibility study. JMIR Form Res. 2021;5(3):e18240. doi: 10.2196/18240.
    1. Managing Insulin With a Voice AI (MIVA). 2021 Oct 1 [last updated 2021 Nov 1; cited 2022 March1]. In: [Internet]. Bethesda (MD): U.S. National Library of Medicine. 2000. Available from Identifier: NCT05081011
    1. Nurse AMIE for Echo Show: Randomized Control Trial. 2020 Dec 19 [last updated 2022 Jan 24; cited 2022 Mark 1]. In: [Internet]. Bethesda (MD): U.S. National Library of Medicine. 2000. Available from Identifier: NCT04673019
    1. Arem H, Scott R, Greenberg D, Kaltman R, Lieberman D, Lewin D. Assessing breast cancer survivors’ perceptions of using voice-activated technology to address insomnia: feasibility study featuring focus groups and in-depth interviews. JMIR Cancer. 2020;6(1):e15859. doi: 10.2196/15859.
    1. Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012;35(2):287–302. doi: 10.5665/sleep.1642.
    1. Johnson JA, Rash JA, Campbell TS, 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;27:20–28. doi: 10.1016/j.smrv.2015.07.001.
    1. Zhou ES, Clark K, Recklitis CJ, Obenchain R, Loscalzo M. Sleepless from the get go: sleep problems prior to initiating cancer treatment. Int J Behav Med. 2018;25(5):502–516. doi: 10.1007/s12529-018-9715-2.

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