N/A
N=226
PERSONAL - Sleep In Breast Cancer
Insomnia · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05093426 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Prevalence of Insomnia in a Cohort of Breast Cancer Patients — 170 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Stage 2 Digital sleep diary app (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Closed Loop Medicine
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Insomnia in a Cohort of Breast Cancer Patients |
170 | — |
| 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. |
50; 90; 71; 9 | — |
| 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. |
78.5 | — |
| 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. |
18.9; 18.5; 17.9; 17.1; 16.5; 16.5 | — |
| 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. |
18.9; 18.5; 17.9; 17.1; 16.5; 16.5 | — |
| 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 |
66 | — |
| 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. |
26; 58; 21; 12; 13; 1 | — |
| SECONDARY Safety of the Digital Sleep Diary |
51; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05093426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.