PERSONAL - Sleep In Breast Cancer

Closed Loop Medicine

Status: Completed

Conditions: Breast Cancer; Insomnia

Treatments: Other: Stage 2 Digital sleep diary app

Study type: Observational

Funder types: Industry

Identifiers

NCT05093426

CLM-INS-004

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

226 participants in 1 patient group

Insomnia in Breast cancer cohort

Description:

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.

Treatment:

Other: Stage 2 Digital sleep diary app