Clinical trial NCT05816460: The Sleepio After Cancer Study
Official title: The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Cancer
Keywords: Cancer
Insomnia
Sleep
Survivorship
Quality of life
Anxiety
Depression
Fatigue
Hot Flushes
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: Big Health Ltd.
name: Research Electronic Data Capture (REDCap)
First posted: 2023-04-18
Enrollment: 308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score
timeFrame: 24 weeks
measure: Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)
timeFrame: 12, 24 and 33 weeks
measure: Fatigue as measured by the Fatigue Symptom inventory (FSI)
timeFrame: 12, 24 and 33 weeks
measure: Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)
timeFrame: 12, 24 and 33 weeks
measure: Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire
timeFrame: 12, 24 and 33 weeks
measure: The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: 12, 24 and 33 weeks
Other outcomes:
measure: Immune cell count
timeFrame: 24 weeks
measure: Immune Cell Percentage
timeFrame: 24 weeks
measure: Immune Cell Function
timeFrame: 24 weeks.
measure: Expression of immune checkpoints
timeFrame: 24 weeks
measure: Number of inflammatory markers and cytokines in peripheral blood sample.
timeFrame: 24 weeks
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Donal Brennan, PhD
role: PRINCIPAL_INVESTIGATOR
References: