Breast Cancer, Insomnia
Conditions
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.
Interventions
OTHERStage 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.
Sponsors
Closed Loop Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 Quality of Life Over a Three-week Period. | 3 weeks | 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insomnia in Breast Cancer Cohort 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.
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. | 220 |
| Total | 220 |
Baseline characteristics
| Characteristic | Insomnia in Breast Cancer Cohort |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 9.88 |
| Body Mass Index (kg/m^2) Morbidly obese | 14 Participants |
| Body Mass Index (kg/m^2) Normal weight | 68 Participants |
| Body Mass Index (kg/m^2) Obese | 59 Participants |
| Body Mass Index (kg/m^2) Overweight | 74 Participants |
| Body Mass Index (kg/m^2) Underweight | 3 Participants |
| Breastfeeding | 218 Participants |
| Education level College | 67 Participants |
| Education level Primary school | 1 Participants |
| Education level Secondary school | 48 Participants |
| Education level University | 102 Participants |
| Employment status Full-time work | 111 Participants |
| Employment status Part-time work | 52 Participants |
| Employment status Retired | 42 Participants |
| Employment status Student | 1 Participants |
| Employment status Unemployed | 12 Participants |
| Height (cm) | 163.5 cm STANDARD_DEVIATION 7.33 |
| Marital status Married or living with partner | 163 Participants |
| Marital status Separated or divorced | 27 Participants |
| Marital status Single | 22 Participants |
| Marital status Widowed | 6 Participants |
| Menopausal status Don't know | 26 Participants |
| Menopausal status Peri-menopause | 37 Participants |
| Menopausal status Post-menopause | 123 Participants |
| Menopausal status Pre-menopause | 32 Participants |
| Prescribed medication for sleep issues No | 156 Participants |
| Prescribed medication for sleep issues Yes | 12 Participants |
| Race/Ethnicity, Customized Ethnicity Asian/British Asian | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Black/African/Black British | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed/Multiple ethnic backgrounds | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Other ethnic group | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 202 Participants |
| Regular night-work/shift work No | 216 Participants |
| Regular night-work/shift work Yes | 2 Participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sleep apnoea No | 215 Participants |
| Sleep apnoea Yes | 3 Participants |
| Sleep difficulties No | 50 Participants |
| Sleep difficulties Yes | 168 Participants |
| Sleep difficulties started/worsened since diagnosis No | 54 Participants |
| Sleep difficulties started/worsened since diagnosis Yes | 150 Participants |
| Smartphone access No | 4 Participants |
| Smartphone access Yes | 214 Participants |
| Weight (kg) | 76.1 kg STANDARD_DEVIATION 16.68 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 51 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Prevalence of Insomnia in a Cohort of Breast Cancer Patients
Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index
Time frame: 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insomnia in Breast Cancer Cohort | Prevalence of Insomnia in a Cohort of Breast Cancer Patients | 170 Participants |
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.
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).
Time frame: 3 weeks
Population: These are descriptions of the subgroups that were analysed based on breast cancer stage, tumour staging and treatment regimen therefore the reported numbers reflect the number of participants in each subgroup.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insomnia in Breast Cancer Cohort | 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. | Stage I breast cancer participants who reported as having subthreshold insomnia | 12 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Tumour staging T2 participants who reported as having insomnia (ISI score 8 or above) | 47 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Tumour staging T3 participants who reported as having insomnia (ISI score 8 or above) | 14 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Tumour staging DCIS participants who reported as having insomnia (ISI score 8 or above) | 1 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Systemic anti-cancer therapy participants who reported as having insomnia (ISI score 8 or above) | 54 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Dexamethasone treatment participants who reported as having insomnia (ISI score 8 or above) | 12 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Radiation therapy participants who reported as having insomnia (ISI score 8 or above) | 34 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Targeted therapy participants who reported as having insomnia (ISI score 8 or above) | 16 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Hormonal treatment participants who reported as having insomnia (ISI score 8 or above) | 39 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Tumour staging T1 participants who reported as having insomnia (ISI score 8 or above) | 43 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage I breast cancer participants who reported as having insomnia (ISI score 8 or above) | 26 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage II breast cancer participants who reported as having insomnia (ISI score 8 or above) | 58 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage III breast cancer participants who reported as having insomnia (ISI score 8 or above) | 21 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage I breast cancer participants who reported as having clinical insomnia (moderate severity) | 13 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage I breast cancer participants who reported as having clinical insomnia (severe) | 1 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage II breast cancer participants who reported as having subthreshold insomnia | 30 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage II breast cancer participants who reported as having clinical insomnia (moderate severity) | 25 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage II breast cancer participants who reported as having clinical insomnia (severe) | 3 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage III breast cancer participants who reported as having subthreshold insomnia | 9 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage III breast cancer participants who reported as having clinical insomnia (moderate severity) | 12 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Stage III breast cancer participants who reported as having clinical insomnia (severe) | 0 Participants |
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.
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)
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insomnia in Breast Cancer Cohort | 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. | No clinically significant insomnia | 50 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Subthreshold insomnia | 90 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Clinical insomnia (moderate severity) | 71 Participants |
| Insomnia in Breast Cancer Cohort | 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. | Clinical insomnia (severe) | 9 Participants |
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.
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).
Time frame: 3 weeks
Population: 7 missing values at Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Emotional well-being - Total Baseline score | 16.5 score on a scale | Standard Deviation 3.78 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Physical well-being - Total Baseline score | 18.9 score on a scale | Standard Deviation 5 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Physical well-being - Total Day 21 Score | 18.5 score on a scale | Standard Deviation 5.4 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Social/family well-being - Total Baseline score | 17.9 score on a scale | Standard Deviation 4.12 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Social/family well-being - Total Day 21 score | 17.1 score on a scale | Standard Deviation 4.49 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Emotional well-being - Total Day 21 score | 16.5 score on a scale | Standard Deviation 3.86 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Functional well-being - Total Baseline score | 13.0 score on a scale | Standard Deviation 4.99 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Functional well-being - Total Day 21 score | 12.9 score on a scale | Standard Deviation 5.04 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Endocrine Symptom Subscale - Total Day 21 score | 53.1 score on a scale | Standard Deviation 9.96 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Total Baseline score | 120.1 score on a scale | Standard Deviation 18.91 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Total Day 21 score | 118.1 score on a scale | Standard Deviation 20.85 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-G - Total Baseline score | 66.2 score on a scale | Standard Deviation 12.55 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-G - Total Day 21 score | 65.0 score on a scale | Standard Deviation 14.18 |
| Insomnia in Breast Cancer Cohort | 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. | FACT-ES - Endocrine Symptom Subscale - Total Baseline score | 54.0 score on a scale | Standard Deviation 9.88 |
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.
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).
Time frame: 3 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Day 21 | Missing | 7 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Baseline | No problems | 87 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Baseline | Some problems | 18 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Baseline | Missing | 0 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Day 21 | No problems | 60 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Day 21 | Some problems | 38 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Mobility - Day 21 | Missing | 7 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Baseline | No problems | 95 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Baseline | Some problems | 10 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Baseline | Missing | 0 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Day 21 | No problems | 86 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Day 21 | Some problems | 12 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Self-care - Day 21 | Missing | 7 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Baseline | No problems | 51 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Baseline | Some problems | 54 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Baseline | Missing | 0 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Day 21 | No problems | 24 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Day 21 | Some problems | 74 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Usual activities - Day 21 | Missing | 7 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Baseline | No problems | 31 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Baseline | Some problems | 74 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Baseline | Missing | 0 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Day 21 | No problems | 15 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Day 21 | Some problems | 83 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Pain/discomfort - Day 21 | Missing | 7 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Baseline | No problems | 35 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Baseline | Some problems | 70 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Baseline | Missing | 0 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Day 21 | No problems | 30 Participants |
| Insomnia in Breast Cancer Cohort | 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. | EQ-5D-5L - Anxiety/depression - Day 21 | Some problems | 68 Participants |
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.
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).
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insomnia in Breast Cancer Cohort | 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 percentage of time participant is asleep | Standard Deviation 10.71 |
Secondary
Safety of the Digital Sleep Diary
Adverse Events and Serious Adverse Events will be collected and summarised.
Time frame: 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insomnia in Breast Cancer Cohort | Safety of the Digital Sleep Diary | Number of subjects that experienced any Adverse Event | 51 participants |
| Insomnia in Breast Cancer Cohort | Safety of the Digital Sleep Diary | Related to the Sleep Diary | 0 participants |
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
Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.
Time frame: 3 weeks
Population: Number of subjects completing the digital sleep diary on at least 17 out of 21 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insomnia in Breast Cancer Cohort | 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 Participants |