NCT05093426

PERSONAL - Sleep In Breast Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 226 (actual)
• Sponsor: Closed Loop Medicine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-15
• Primary completion: 2022-06-30
• Completion: 2022-08-03
• First posted: 2021-10-26
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

1 site across 1 country: United Kingdom