The Sleepio After Cancer Study (SACS)

The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Insomnia
• Intervention / Treatment: Other: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I); Other: Sleep Hygiene Education (SHE)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donal Brennan, PhD; Phone Number: +353879577510; Email: donal.brennan@ucd.ie
• Study Contact Backup: Name: Teresa Treacy, MB, BCh, BAO; Phone Number: +353861606647; Email: teresa.treacy@ucdconnect.ie

Study Locations

• Ireland
  • Dublin, Ireland, D04V1W8
    • University College Dublin
    • Contact: Donal Brennan, PhD; Phone Number: +353879577510; Email: donal.brennan@ucd.ie
    • Contact: Teresa Treacy, MB, BCh, BAO; Phone Number: +353861606647; Email: teresa.treacy@ucdconnect.ie
    • Sub-Investigator: Teresa Treacy, MB, BCh, BAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I); 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.	Other: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I); Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an online platform called Sleepio (BigHealth Ltd)
Active Comparator: Sleep Hygiene Education (SHE); 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.	Other: Sleep Hygiene Education (SHE); Sleep Hygiene Education (SHE) will be provided electronically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12, 24 and 33 weeks
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.	12, 24 and 33 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.	12, 24 and 33 weeks
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.	12, 24 and 33 weeks
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.	12, 24 and 33 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune cell count	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.	24 weeks
Immune Cell Percentage	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.	24 weeks
Immune Cell Function	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	24 weeks.
Expression of immune checkpoints	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.	24 weeks
Number of inflammatory markers and cytokines in peripheral blood sample.	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.	24 weeks

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Irish Cancer Society; Big Health Ltd.; Research Electronic Data Capture (REDCap)
• Investigators: Principal Investigator: Donal Brennan, PhD, University College Dublin

Study record dates

Study Major Dates

• Study Start (Anticipated): May 22, 2023
• Primary Completion (Anticipated): June 10, 2024
• Study Completion (Anticipated): June 10, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Cancer; Anxiety; Quality of life; Fatigue; Sleep; Insomnia; Survivorship; Hot Flushes
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: WHI22BRE (Other Grant/Funding Number: Irish Cancer Society, Women's Health Initiative)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No