Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

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.

Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.

Stage 2 Digital sleep diary app

Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons)

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.

PERSONAL - Sleep In Breast Cancer

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

To be confirmed whether the individual participant data will be shared

Proportion of breast cancer patients scoring 8 or above on the Insomnia Severity Index

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)

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).

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).

Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.

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.

Adverse Events and Serious Adverse Events will be collected and summarised.

Spots Global Cancer Trial Database for stage 2 digital sleep diary app