The Sleepio After Cancer Study
SACS
1 other identifier
interventional
308
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedMay 23, 2023
May 1, 2023
1.1 years
March 13, 2023
May 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)
12, 24 and 33 weeks
Fatigue as measured by the Fatigue Symptom inventory (FSI)
12, 24 and 33 weeks
Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)
12, 24 and 33 weeks
Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire
12, 24 and 33 weeks
The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
12, 24 and 33 weeks
Other Outcomes (5)
Immune cell count
24 weeks
Immune Cell Percentage
24 weeks
Immune Cell Function
24 weeks.
- +2 more other outcomes
Study Arms (2)
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
EXPERIMENTALDigital 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.
Sleep Hygiene Education (SHE)
ACTIVE COMPARATORThe 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.
Interventions
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an online platform called Sleepio (BigHealth Ltd)
Sleep Hygiene Education (SHE) will be provided electronically
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College Dublinlead
- Irish Cancer Societycollaborator
- Big Health Ltd.collaborator
- Research Electronic Data Capture (REDCap)collaborator
Study Sites (1)
University College Dublin
Dublin, D04V1W8, Ireland
Related Publications (2)
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PMID: 41170811DERIVEDTreacy T, O'Meara Y, Galligan MC, Henry AL, Lensen SF, Higgins MJ, Hickey M, Brennan DJ. The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Contemp Clin Trials. 2024 Jan;136:107337. doi: 10.1016/j.cct.2023.107337. Epub 2023 Sep 21.
PMID: 37741507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donal Brennan, PhD
University College Dublin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
April 18, 2023
Study Start
May 22, 2023
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
May 23, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share