PERSONAL-SLEEP IN BREAST CANCER
Research type
Research Study
Full title
Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients with Breast Cancer
IRAS ID
302786
Contact name
Anne Armstrong
Contact email
Sponsor organisation
Closed Loop Medicine
Clinicaltrials.gov Identifier
TBC, www.clinicaltrials.gov
Duration of Study in the UK
0 years, 4 months, 31 days
Research 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 are difficult to assess. Thus, these issues require further investigation using standardised and validated measures.
In this observational study, we aim to investigate 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. In Stage 1 of the study, 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 sleep 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 regarding their quality of life and health. This research will provide a detailed understanding of sleep difficulties and insomnia in patients with breast cancer and will establish a well-defined cohort of breast cancer patients with insomnia in readiness for potential recruitment into a subsequent interventional trial to test a new treatment currently in development.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0156
Date of REC Opinion
19 Nov 2021
REC opinion
Favourable Opinion