Study Results
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View full resultsBasic Information
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COMPLETED
226 participants
OBSERVATIONAL
2022-01-15
2022-08-03
Brief Summary
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In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Insomnia in Breast cancer cohort
A single cohort will be observed in Stage 1 to assess the prevalence of insomnia suffered by participants who suffer from breast cancer. A subset of participants will continue to Stage 2 to use a digital sleep diary app for an observational period of 3 weeks.
Stage 2 Digital sleep diary app
Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.
Interventions
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Stage 2 Digital sleep diary app
Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years.
* Informed consent to Stage 1 of the study
* Diagnosis of Stage I, II or III breast cancer within the previous 12 months
Stage 2:
* Informed consent to Stage 2 of the study
* Current Sleep Disturbance; a score of 8 or more on the Insomnia Severity Index.
* History of sleep disturbance prior to the screening/baseline consultation; with beginning or worsening of sleep disturbance since breast cancer diagnosis e.g. sleep problems began or get worse with the diagnosis of breast cancer or with chemotherapy.
* Possession of a suitable smartphone that participant can use independently.
Exclusion Criteria
* Participants who have limited or no understanding of spoken and/or written English.
* Other diagnosis of cancer, not including basal cell carcinoma of the skin or cervical carcinoma in situ, within the previous 5 years
Stage 2:
* Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smartphone.
* Known and/or treated sleep apnoea
* Regular shift work or night work (defined as \>1 overnight shift per month)
* Breast feeding
18 Years
ALL
No
Sponsors
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Closed Loop Medicine
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons)
Role: PRINCIPAL_INVESTIGATOR
Christie NHS Foundation Trust
Locations
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Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Ruel S, Ivers H, Savard MH, Gouin JP, Lemieux J, Provencher L, Caplette-Gingras A, Bastien C, Morin CM, Couture F, Savard J. Insomnia, immunity, and infections in cancer patients: Results from a longitudinal study. Health Psychol. 2020 May;39(5):358-369. doi: 10.1037/hea0000811. Epub 2019 Dec 19.
Kwak A, Jacobs J, Haggett D, Jimenez R, Peppercorn J. Evaluation and management of insomnia in women with breast cancer. Breast Cancer Res Treat. 2020 Jun;181(2):269-277. doi: 10.1007/s10549-020-05635-0. Epub 2020 Apr 20.
Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245.
Fontes F, Pereira S, Costa AR, Goncalves M, Lunet N. The impact of breast cancer treatments on sleep quality 1 year after cancer diagnosis. Support Care Cancer. 2017 Nov;25(11):3529-3536. doi: 10.1007/s00520-017-3777-6. Epub 2017 Jun 16.
Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.
Hajj A, Hachem R, Khoury R, Nehme T, Hallit S, Nasr F, Karak FE, Chahine G, Kattan J, Khabbaz LR. Clinical and Genetic Factors Associated With the Breast Cancer-Related Sleep Disorders: The "CAGE-Sleep" Study-A Cross-Sectional Study. J Pain Symptom Manage. 2021 Sep;62(3):e46-e55. doi: 10.1016/j.jpainsymman.2021.02.022. Epub 2021 Feb 22.
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 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
Brzecka A, Sarul K, Dyla T, Avila-Rodriguez M, Cabezas-Perez R, Chubarev VN, Minyaeva NN, Klochkov SG, Neganova ME, Mikhaleva LM, Somasundaram SG, Kirkland CE, Tarasov VV, Aliev G. The Association of Sleep Disorders, Obesity and Sleep-Related Hypoxia with Cancer. Curr Genomics. 2020 Sep;21(6):444-453. doi: 10.2174/1389202921999200403151720.
Palesh O, Aldridge-Gerry A, Zeitzer JM, Koopman C, Neri E, Giese-Davis J, Jo B, Kraemer H, Nouriani B, Spiegel D. Actigraphy-measured sleep disruption as a predictor of survival among women with advanced breast cancer. Sleep. 2014 May 1;37(5):837-42. doi: 10.5665/sleep.3642.
Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895.
Marion LP, Ivers H, Savard J. Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy. Behav Sleep Med. 2021 Jan-Feb;19(1):70-82. doi: 10.1080/15402002.2019.1707203. Epub 2019 Dec 24.
O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6 Suppl 1D:S6-14. doi: 10.1016/s1098-3597(05)80002-x.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
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 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
Horsch CH, Lancee J, Griffioen-Both F, Spruit S, Fitrianie S, Neerincx MA, Beun RJ, Brinkman WP. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. J Med Internet Res. 2017 Apr 11;19(4):e70. doi: 10.2196/jmir.6524.
Kang SG, Kang JM, Cho SJ, Ko KP, Lee YJ, Lee HJ, Kim L, Winkelman JW. Cognitive Behavioral Therapy Using a Mobile Application Synchronizable With Wearable Devices for Insomnia Treatment: A Pilot Study. J Clin Sleep Med. 2017 Apr 15;13(4):633-640. doi: 10.5664/jcsm.6564.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Fallowfield LJ, Leaity SK, Howell A, Benson S, Cella D. Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B. Breast Cancer Res Treat. 1999 May;55(2):189-99. doi: 10.1023/a:1006263818115.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Epidemiology of Insomnia - Prevalence, Course, Risk Factors, and Public Health Burden
Insomnia in breast cancer: prevalence and associated factors
Disruption of sleep, sleep-wake activity rhythm, and nocturnal melatonin production in breast cancer patients undergoing adjuvant chemotherapy: a prospective cohort study
Joint statement on seeking consent by electronic methods
Consent and Participant Information Guidance
Sample Size Calculator for Estimating a Single Proportion
Construction and Evaluation of a User Experience Questionnaire
Other Identifiers
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CLM-INS-004
Identifier Type: -
Identifier Source: org_study_id
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