Back to resultsThe Sleepio After Cancer Study (SACS)
Primary Purpose
Insomnia, Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Sleep Hygiene Education (SHE)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Cancer, Insomnia, Sleep, Survivorship, Quality of life, Anxiety, Depression, Fatigue, Hot Flushes
Eligibility Criteria
Inclusion Criteria: Women Aged 18 and over Sleep Condition Indicator (SCI) score of 16 or less Current or past diagnosis of cancer Fluent in written and spoken English Internet access and comfortable with its use Exclusion Criteria: Acute Illness Life expectancy less than 6 months Evidence of another sleep disorder Untreated Psychiatric Disorder Drug Misuse Currently receiving CBT for insomnia from a health professional or taking part in an online treatment programme for insomnia Any condition that may be exacerbated by sleep restriction therapy (Obstructive sleep apnoea, Bipolar disorder, psychosis, schizophrenia, epilepsy, current suicidal ideation, shift work, dementia, Parkinson's disease, Lewy body dementia) Planned Major Surgery Commencement or a change in sleep medication within the last 4 weeks
Sites / Locations
- University College Dublin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Sleep Hygiene Education (SHE)
Arm Description
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be provided on an online digital platform called Sleepio (BigHealth Ltd). Sleepio delivers fully automated CBT-I through 6 sessions, lasting an average of 20 minutes each, over the course of 6 weeks.
The Sleep Hygiene Education (SHE) provided is based on recognised sleep hygiene advice and will consist of behavioural recommendations concerning lifestyle and environmental factors associated with sleep and insomnia. SHE will be delivered electronically.
Outcomes
Primary Outcome Measures
Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score
The primary outcome will be the mean continuous change in Sleep Condition Indicator score in the intervention arm compared to the control arm at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. The magnitude of change in SCI score that represents a reliable improvement on the Sleep Condition Indicator is 7 scale points
Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score
The co-primary outcome will be the proportion of women with an SCI score > 16 at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. A score of 16 or less is indicative of insomnia.
Secondary Outcome Measures
Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)
The Glasgow Sleep Impact Index (GSII) is a self report measure which asks patients to generate and assess three domains of impairment unique to their own experience. The three generated areas of impairment are ranked in order of concern on a scale of 1-3, with 1 being the most concerning impairment. Each impairment is then rated on a visual analogue scale with respect to impact in the last two weeks.
Fatigue as measured by the Fatigue Symptom inventory (FSI)
The Fatigue Symptom inventory (FSI) is a method of evaluating the impact of fatigue in people with cancer. The scale is composed of 14 items and is designed to evaluate multiple aspects of fatigue, including its perceived severity, frequency, and interference with daily functioning. Items use an 11-point, likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue. A score of zero denotes no interference, whilst a score of 10 indicated extreme interference). A global score can be obtained for items 1-13.
Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)
The Patient Health Questionnaire - 8 (PHQ8) is an 8 item questionnaire used for the diagnosis of depression. Each of the 8 items are allocated a score of 0-3. Scores can range from 0-24. A score of more than 10 indicates a high likelihood of clinical depression. Scores of more than 20 are indicative of severe disease.
Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire
The Generalised Anxiety Disorder - 7 (GAD7) is a 7 item questionnaire used to screen for generalised anxiety disorder. Each of the 7 items can be allocated a score of 0-3. Total score can range from 0-21. A score of more than 10 indicated a high likelihood of significant anxiety.
The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
The Hot Flushes as measured by the Hot Flash Related Daily Interference Scale is a tool for assessing the impact of hot flushes on quality of life. The scale measures the impact of hot flashes on overall Quality of life, as well as on 9 specific activities (work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life). The scale consists of a series of 0-10-point numeric rating scales. A score of zero reflects no interference and a score of 10 denotes complete interference. Total score can range from 0-100.
Full Information
NCT ID
NCT05816460
First Posted
March 13, 2023
Last Updated
May 19, 2023
Sponsor
University College Dublin
Collaborators
Irish Cancer Society, Big Health Ltd., Research Electronic Data Capture (REDCap)
1. Study Identification
Unique Protocol Identification Number
NCT05816460
Brief Title
The Sleepio After Cancer Study
Acronym
SACS
Official Title
The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 22, 2023 (Anticipated)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
Collaborators
Irish Cancer Society, Big Health Ltd., Research Electronic Data Capture (REDCap)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.
Detailed Description
Women who are eligible and provide informed consent will be enrolled into this 2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm). The primary outcome will be the mean continuous change in sleep condition indicator (SCI) score in the intervention arm compared to the control arm at 6 months. In addition to this, the proportion of women with an SCI > 16 at 6 months will be assessed. Secondary outcomes will include fatigue, sleep related quality of life, depression, anxiety, as well as hot flush interference in those experiencing vasomotor symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Cancer
Keywords
Cancer, Insomnia, Sleep, Survivorship, Quality of life, Anxiety, Depression, Fatigue, Hot Flushes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Arm Type
Experimental
Arm Description
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be provided on an online digital platform called Sleepio (BigHealth Ltd). Sleepio delivers fully automated CBT-I through 6 sessions, lasting an average of 20 minutes each, over the course of 6 weeks.
Arm Title
Sleep Hygiene Education (SHE)
Arm Type
Active Comparator
Arm Description
The Sleep Hygiene Education (SHE) provided is based on recognised sleep hygiene advice and will consist of behavioural recommendations concerning lifestyle and environmental factors associated with sleep and insomnia. SHE will be delivered electronically.
Intervention Type
Other
Intervention Name(s)
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Intervention Description
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an online platform called Sleepio (BigHealth Ltd)
Intervention Type
Other
Intervention Name(s)
Sleep Hygiene Education (SHE)
Intervention Description
Sleep Hygiene Education (SHE) will be provided electronically
Primary Outcome Measure Information:
Title
Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score
Description
The primary outcome will be the mean continuous change in Sleep Condition Indicator score in the intervention arm compared to the control arm at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. The magnitude of change in SCI score that represents a reliable improvement on the Sleep Condition Indicator is 7 scale points
Time Frame
24 weeks
Title
Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score
Description
The co-primary outcome will be the proportion of women with an SCI score > 16 at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. A score of 16 or less is indicative of insomnia.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)
Description
The Glasgow Sleep Impact Index (GSII) is a self report measure which asks patients to generate and assess three domains of impairment unique to their own experience. The three generated areas of impairment are ranked in order of concern on a scale of 1-3, with 1 being the most concerning impairment. Each impairment is then rated on a visual analogue scale with respect to impact in the last two weeks.
Time Frame
12, 24 and 33 weeks
Title
Fatigue as measured by the Fatigue Symptom inventory (FSI)
Description
The Fatigue Symptom inventory (FSI) is a method of evaluating the impact of fatigue in people with cancer. The scale is composed of 14 items and is designed to evaluate multiple aspects of fatigue, including its perceived severity, frequency, and interference with daily functioning. Items use an 11-point, likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue. A score of zero denotes no interference, whilst a score of 10 indicated extreme interference). A global score can be obtained for items 1-13.
Time Frame
12, 24 and 33 weeks
Title
Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)
Description
The Patient Health Questionnaire - 8 (PHQ8) is an 8 item questionnaire used for the diagnosis of depression. Each of the 8 items are allocated a score of 0-3. Scores can range from 0-24. A score of more than 10 indicates a high likelihood of clinical depression. Scores of more than 20 are indicative of severe disease.
Time Frame
12, 24 and 33 weeks
Title
Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire
Description
The Generalised Anxiety Disorder - 7 (GAD7) is a 7 item questionnaire used to screen for generalised anxiety disorder. Each of the 7 items can be allocated a score of 0-3. Total score can range from 0-21. A score of more than 10 indicated a high likelihood of significant anxiety.
Time Frame
12, 24 and 33 weeks
Title
The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
Description
The Hot Flushes as measured by the Hot Flash Related Daily Interference Scale is a tool for assessing the impact of hot flushes on quality of life. The scale measures the impact of hot flashes on overall Quality of life, as well as on 9 specific activities (work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life). The scale consists of a series of 0-10-point numeric rating scales. A score of zero reflects no interference and a score of 10 denotes complete interference. Total score can range from 0-100.
Time Frame
12, 24 and 33 weeks
Other Pre-specified Outcome Measures:
Title
Immune cell count
Description
We will collect a blood sample from a cohort of patients enrolled in the trial at baseline and at 24 weeks post intervention. A blood sample will be collected from a group of healthy volunteers as a comparator. To assess if improved sleep results in a reduction in immune cell count, peripheral mononuclear blood cells will be isolated from a peripheral blood sample from a subset of patients. Immune cell count will be evaluated by flow cytometry. We will determine the number of the following immune cells: CD4 T cells, CD8 T cells, B cells, Natural Killer Cells, Monocytes and Gamma Delta T cells.
Time Frame
24 weeks
Title
Immune Cell Percentage
Description
We will collect a blood sample from a cohort of patients enrolled in the trial at baseline and at 24 weeks post intervention. A blood sample will be collected from a group of healthy volunteers as a comparator. To assess if improved sleep results in a reduction in immune percentage, peripheral mononuclear blood cells will be isolated from a peripheral blood sample from a subset of patients. Immune cell percentage will be evaluated by flow cytometry. We will determine the percentage of the following immune cells: CD4 T cells, CD8 T cells, B cells, Natural Killer Cells, Monocytes and Gamma Delta T cells.
Time Frame
24 weeks
Title
Immune Cell Function
Description
We will collect a blood sample from a cohort of patients enrolled in the trial at baseline and at 24 weeks post intervention. A blood sample will be collected from a group of healthy volunteers as a comparator. To assess if improved sleep results in immune cell function, the activation markers of immune cells will be measured using flow cytometry. The activation markers on T cells the Natural Killer Cells will be measured: HLA-DR, CD69, Nur77, GzB, Perforin, IL2, IL17A, IL17F, IL10, TNF-alpha, IFN-gamma. The activation markers on monocytes will be measured: TNF-alpha, IL1-beta, IL6
Time Frame
24 weeks.
Title
Expression of immune checkpoints
Description
We will collect a blood sample from a cohort of patients enrolled in the trial at baseline and at 24 weeks post intervention. A blood sample will be collected from a group of healthy volunteers as a comparator. To assess if improved sleep results in a change in the expression of immune checkpoints on T cells and Natural Killer cells, an evaluation of these cells and the expression of the following immune checkpoints will be performed by flow cytometry: PD1, TIGIT, BTLA, CD223, CD96, CD112R, LAG3, TIM3.
Time Frame
24 weeks
Title
Number of inflammatory markers and cytokines in peripheral blood sample.
Description
We will collect a blood sample from a cohort of patients enrolled in the trial at baseline and at 24 weeks post intervention. A blood sample will be collected from a group of healthy volunteers as a comparator. To assess if improved sleep results in a reduction in the number of inflammatory markers and cytokines measured in the serum of a peripheral blood sample using a multiples assay. The following will be measured: TNF-alpha, IL2-beta, PGD2, IL10, IL4, IFN.
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women
Aged 18 and over
Sleep Condition Indicator (SCI) score of 16 or less
Current or past diagnosis of cancer
Fluent in written and spoken English
Internet access and comfortable with its use
Exclusion Criteria:
Acute Illness
Life expectancy less than 6 months
Evidence of another sleep disorder
Untreated Psychiatric Disorder
Drug Misuse
Currently receiving CBT for insomnia from a health professional or taking part in an online treatment programme for insomnia
Any condition that may be exacerbated by sleep restriction therapy (Obstructive sleep apnoea, Bipolar disorder, psychosis, schizophrenia, epilepsy, current suicidal ideation, shift work, dementia, Parkinson's disease, Lewy body dementia)
Planned Major Surgery
Commencement or a change in sleep medication within the last 4 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donal Brennan, PhD
Phone
+353879577510
Email
donal.brennan@ucd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Treacy, MB, BCh, BAO
Phone
+353861606647
Email
teresa.treacy@ucdconnect.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donal Brennan, PhD
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Dublin
City
Dublin
ZIP/Postal Code
D04V1W8
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donal Brennan, PhD
Phone
+353879577510
Email
donal.brennan@ucd.ie
First Name & Middle Initial & Last Name & Degree
Teresa Treacy, MB, BCh, BAO
Phone
+353861606647
Email
teresa.treacy@ucdconnect.ie
First Name & Middle Initial & Last Name & Degree
Teresa Treacy, MB, BCh, BAO
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Sleepio After Cancer Study
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