PERSONAL - Sleep In Breast Cancer

Breast Cancer Clinical Trial

Official title:

Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093426
• Other study ID #: CLM-INS-004
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: August 3, 2022

Study information

• Verified date: November 2022
• Source: Closed Loop Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: August 3, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Stage 1:

• 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:

Stage 1:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Insomnia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Christie NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Closed Loop Medicine

Country where clinical trial is conducted

United Kingdom, 

References & Publications (18)

Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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). pii: zsy245. doi: 10.1093/sleep/zsy245. — View Citation

Fontes F, Pereira S, Costa AR, Gonçalves 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6 Suppl 1D:S6-14. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of insomnia in a cohort of breast cancer patients	Proportion of breast cancer patients scoring 8 or above on the Insomnia Severity Index	3 weeks
Secondary	In patients with breast cancer experiencing insomnia (defined as score of 8 or more on the Insomnia Severity Index; ISI scale), to assess insomnia severity over a three-week period.	Insomnia severity using Insomnia Severity Index (min. 0, max. 28 where higher scores mean a worse outcome). With severity classified by total score for the Insomnia Severity Index: 0-7 no significant insomnia, 8-14 Subthreshold insomnia, 15-21 Clinical insomnia (moderate severity) and 22-28 Clinical Insomnia (Severe severity)	2 weeks
Secondary	In patients with breast cancer experiencing insomnia (defined as score of 8 or more on the Insomnia Severity Index; ISI scale), to assess Sleep efficiency over a three-week period.	Sleep efficiency (the % of time a participant is asleep whilst in bed) measured using Sleep diary (derived from total time asleep relative to total time in bed).	3 weeks
Secondary	In patients with breast cancer experiencing insomnia (defined as score of 8 or more on the Insomnia Severity Index; ISI scale), to assess Quality of Life over a three-week period.	Quality of Life using EQ-5D-5L questionnaire (multiple choice questions regarding Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression as well as measure of % of health using scale where higher percentage is greater outcome) and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaire (questions regarding Physical well-being, Social/Family well-being, Emotional, Functional well-being and Additional concerns using scale of 0 - 4 where 0 is Not at all, 1 is A little bit, 2 is Some-what, 3 is Quite a bit and 4 is Very much).	3 weeks
Secondary	To assess: - Compliance of data entry into the digital sleep diary - Feasibility and experience of patients to input data relating to their sleep into a mobile phone application daily	Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.	3 weeks
Secondary	Associations between insomnia prevalence and severity as measured by the insomnia severity index and quality of life (EQ-5D-5L and FACT-ES) with clinical or treatment characteristics of breast cancer patients.	Assessment of insomnia prevalence, severity, and quality of life in subgroups based on clinical/treatment characteristics including breast cancer stage, treatment regime and baseline insomnia severity.	3 weeks
Secondary	Safety of the digital sleep diary	Adverse Events and Serious Adverse Events will be collected and summarised.	3 weeks

External Links

•   A randomised controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioural therapy for insomnia
•   Consent and Participant Information Guidance
•   Construction and Evaluation of a User Experience Questionnaire
•   Disruption of sleep, sleep-wake activity rhythm, and nocturnal melatonin production in breast cancer patients undergoing adjuvant chemotherapy: a prospective cohort study
•   Empirical validation of the Insomnia Severity Index in cancer patients
•   Epidemiology of Insomnia - Prevalence, Course, Risk Factors, and Public Health Burden
•   Insomnia in breast cancer: prevalence and associated factors
•   Joint statement on seeking consent by electronic methods
•   Prevalence, Clinical Characteristics, and Risk Factors for Insomnia in the Context of Breast Cancer
•   Sample Size Calculator for Estimating a Single Proportion
•   Sleep as a public health concern: insomnia and mental health
•   The Pathophysiologic Role of Disrupted Circadian and Neuroendocrine Rhythms in Breast Carcinogenesis
•   The Relationship Between Insomnia and Cognitive Impairment in Breast Cancer Survivors