Trial Outcomes & Findings for PERSONAL - Sleep In Breast Cancer (NCT NCT05093426)
NCT ID: NCT05093426
Last Updated: 2025-04-03
Results Overview
Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index
Recruitment status
COMPLETED
Target enrollment
226 participants
Primary outcome timeframe
3 weeks
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Stage 1
STARTED
|
226
|
|
Stage 1
COMPLETED
|
220
|
|
Stage 1
NOT COMPLETED
|
6
|
|
Stage 2
STARTED
|
120
|
|
Stage 2
COMPLETED
|
105
|
|
Stage 2
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 missing values
Baseline characteristics by cohort
| Measure |
Insomnia in Breast Cancer Cohort
n=220 Participants
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.
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 9.88 • n=218 Participants • 2 missing values
|
|
Sex: Female, Male
Female
|
218 Participants
n=218 Participants • 2 missing values
|
|
Sex: Female, Male
Male
|
0 Participants
n=218 Participants • 2 missing values
|
|
Race/Ethnicity, Customized
Ethnicity · Asian/British Asian
|
6 Participants
n=218 Participants • 2 missing values
|
|
Race/Ethnicity, Customized
Ethnicity · Black/African/Black British
|
5 Participants
n=218 Participants • 2 missing values
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed/Multiple ethnic backgrounds
|
4 Participants
n=218 Participants • 2 missing values
|
|
Race/Ethnicity, Customized
Ethnicity · Other ethnic group
|
1 Participants
n=218 Participants • 2 missing values
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
202 Participants
n=218 Participants • 2 missing values
|
|
Smartphone access
Yes
|
214 Participants
n=218 Participants • 2 missing values
|
|
Smartphone access
No
|
4 Participants
n=218 Participants • 2 missing values
|
|
Weight (kg)
|
76.1 kg
STANDARD_DEVIATION 16.68 • n=218 Participants • 2 missing values
|
|
Height (cm)
|
163.5 cm
STANDARD_DEVIATION 7.33 • n=218 Participants • 2 missing values
|
|
Body Mass Index (kg/m^2)
Underweight
|
3 Participants
n=218 Participants • 2 missing values
|
|
Body Mass Index (kg/m^2)
Normal weight
|
68 Participants
n=218 Participants • 2 missing values
|
|
Body Mass Index (kg/m^2)
Overweight
|
74 Participants
n=218 Participants • 2 missing values
|
|
Body Mass Index (kg/m^2)
Obese
|
59 Participants
n=218 Participants • 2 missing values
|
|
Body Mass Index (kg/m^2)
Morbidly obese
|
14 Participants
n=218 Participants • 2 missing values
|
|
Breastfeeding
|
218 Participants
n=218 Participants • 2 missing values
|
|
Regular night-work/shift work
Yes
|
2 Participants
n=218 Participants • 2 missing values
|
|
Regular night-work/shift work
No
|
216 Participants
n=218 Participants • 2 missing values
|
|
Marital status
Married or living with partner
|
163 Participants
n=218 Participants • 2 missing values
|
|
Marital status
Separated or divorced
|
27 Participants
n=218 Participants • 2 missing values
|
|
Marital status
Single
|
22 Participants
n=218 Participants • 2 missing values
|
|
Marital status
Widowed
|
6 Participants
n=218 Participants • 2 missing values
|
|
Education level
College
|
67 Participants
n=218 Participants • 2 missing values
|
|
Education level
Primary school
|
1 Participants
n=218 Participants • 2 missing values
|
|
Education level
Secondary school
|
48 Participants
n=218 Participants • 2 missing values
|
|
Education level
University
|
102 Participants
n=218 Participants • 2 missing values
|
|
Employment status
Full-time work
|
111 Participants
n=218 Participants • 2 missing values
|
|
Employment status
Part-time work
|
52 Participants
n=218 Participants • 2 missing values
|
|
Employment status
Retired
|
42 Participants
n=218 Participants • 2 missing values
|
|
Employment status
Student
|
1 Participants
n=218 Participants • 2 missing values
|
|
Employment status
Unemployed
|
12 Participants
n=218 Participants • 2 missing values
|
|
Menopausal status
Don't know
|
26 Participants
n=218 Participants • 2 missing values
|
|
Menopausal status
Peri-menopause
|
37 Participants
n=218 Participants • 2 missing values
|
|
Menopausal status
Post-menopause
|
123 Participants
n=218 Participants • 2 missing values
|
|
Menopausal status
Pre-menopause
|
32 Participants
n=218 Participants • 2 missing values
|
|
Sleep difficulties
Yes
|
168 Participants
n=218 Participants • 2 missing values
|
|
Sleep difficulties
No
|
50 Participants
n=218 Participants • 2 missing values
|
|
Sleep difficulties started/worsened since diagnosis
Yes
|
150 Participants
n=204 Participants • 16 missing values
|
|
Sleep difficulties started/worsened since diagnosis
No
|
54 Participants
n=204 Participants • 16 missing values
|
|
Prescribed medication for sleep issues
Yes
|
12 Participants
n=168 Participants • 52 missing values
|
|
Prescribed medication for sleep issues
No
|
156 Participants
n=168 Participants • 52 missing values
|
|
Sleep apnoea
Yes
|
3 Participants
n=218 Participants • 2 missing values
|
|
Sleep apnoea
No
|
215 Participants
n=218 Participants • 2 missing values
|
PRIMARY outcome
Timeframe: 3 weeksPercentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=220 Participants
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.
|
|---|---|
|
Prevalence of Insomnia in a Cohort of Breast Cancer Patients
|
170 Participants
|
SECONDARY outcome
Timeframe: 2 weeksInsomnia 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)
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=220 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 3 weeksIn 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).
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=97 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 3 weeksQuality 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).
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=105 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: 7 missing values at Day 21
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).
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=105 Participants
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.
|
|---|---|
|
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
|
|
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 5.00
|
|
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 5.40
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Number of subjects completing the digital sleep diary on at least 17 out of 21 days
Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=105 Participants
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.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=105 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 3 weeksAdverse Events and Serious Adverse Events will be collected and summarised.
Outcome measures
| Measure |
Insomnia in Breast Cancer Cohort
n=105 Participants
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.
|
|---|---|
|
Safety of the Digital Sleep Diary
Number of subjects that experienced any Adverse Event
|
51 participants
|
|
Safety of the Digital Sleep Diary
Related to the Sleep Diary
|
0 participants
|
Adverse Events
Insomnia in Breast Cancer Cohort
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insomnia in Breast Cancer Cohort
n=105 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue
|
19.0%
20/105 • Number of events 20 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Insomnia
|
13.3%
14/105 • Number of events 14 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Itchy skin on arms
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
12/105 • Number of events 12 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
4/105 • Number of events 4 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Edema limbs
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
2/105 • Number of events 2 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
3/105 • Number of events 3 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Stinging on left axilla scar
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Respiratory, thoracic and mediastinal disorders
Covid-19
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Acid reflux
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Investigations
Weight loss
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Vascular disorders
Hot flashes
|
8.6%
9/105 • Number of events 9 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
4/105 • Number of events 4 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Mood changes
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Sleep struggles
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Heartburn
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Bloating
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Low mood
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Neuropathy in the tips fingers and soles
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Depression
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Sore skin
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Infections and infestations
Infection
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Dizzy spells
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Headache
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Nervous system disorders
Migraines
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Blisters
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Anxiety
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Discomfort
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Skin and subcutaneous tissue disorders
Discomfort on palpation
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Psychiatric disorders
Confusion
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Pain around radiotherapy site
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Edema - hands and feet
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Joint ache
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.9%
3/105 • Number of events 3 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Pain
|
1.9%
2/105 • Number of events 2 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Radiating arm pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Reproductive system and breast disorders
Breast pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
General disorders
Intermittent pain
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Gastrointestinal disorders
Mucositis
|
2.9%
3/105 • Number of events 3 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Infections and infestations
Cold sore
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Aching legs
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
|
Musculoskeletal and connective tissue disorders
Aching joints
|
0.95%
1/105 • Number of events 1 • 3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place