PERSONAL - Sleep In Breast Cancer

Completed

Conditions: Insomnia
Breast Cancer

Interventions: Other: Stage 2 Digital sleep diary app

Registration Number: NCT05093426

Lead Sponsor: Closed Loop Medicine

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 226

Inclusion Criteria

Not provided

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insomnia in Breast cancer cohort	Stage 2 Digital sleep diary app	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of Insomnia in a Cohort of Breast Cancer Patients	3 weeks	Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index

Secondary Outcome Measures

Name	Time	Method
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	3 weeks	Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.
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.	3 weeks	Assessment to determine if there is any association or correlation between insomnia prevalence and severity as well as quality of life (using insomnia severity index and EQ-5D-5L and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaires) for patients in subgroups based on clinical or treatment characteristics i.e. breast cancer stage (Stage I, II or III), tumour staging (T1, T2, T3 or DCIS) treatment regimen (Systemic treatment, Dexamethasone treatment, Radiation therapy, Hormonal or Targeted Therapy as well as time since start of chemotherapy and current systemic anti-cancer therapy).
Safety of the Digital Sleep Diary	3 weeks	Adverse Events and Serious Adverse Events will be collected and summarised.
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.	2 weeks	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)
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.	3 weeks	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. 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).
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.	3 weeks	EQ-5D-5L questionnaire: multiple choice questions for Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression and % of health where a higher % is a greater outcome). Functional Assessment of Cancer Therapy - Endocrine Systems (FACT-ES) (sub-scales: Physical well-being, Social/Family well-being, Emotional, Functional well-being and Endocrine symptoms): each question in sub-scales are scored using a 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. Scores for questions are added to give total baseline and total day 21 score for each sub-scale. Minimum total score is 0 for all sub-scales, the maximum scores are 28 for Physical, Social/Family and Functional well-being sub-scales, 24 for the Emotional well-being sub-scale, 76 for Endocrine symptoms. A lower total score represents better outcomes. FACT-ES = Total of subscale scores (0-184). FACT-G = Total of subscale scores excluding endocrine system (0-108).