InsomniaESTABLISHNCT07859098
Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
A study testing Sleep hygiene education and Cognitive behavioural therapy for insomnia (CBTi) in people with Insomnia and Breast Cancer Metastatic Breast Cancer, run by University of Strathclyde at 1 site in United Kingdom.
Trial summary
The purpose of this trial is to evaluate an intervention designed to improve insomnia and sleep in people living with secondary breast cancer. The study will assess whether the intervention is feasible and acceptable to deliver and participate in, and whether it may improve sleep and related outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Breast Cancer Metastatic Breast Cancer
- What is being tested?
- Sleep hygiene education and Cognitive behavioural therapy for insomnia (CBTi)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of secondary breast cancer;
- Have a prognosis of greater than 6 months;
- Be aged 18 years or over;
- Be willing and able to provide informed consent;
- Meet screening criteria for chronic insomnia, defined as dissatisfaction with sleep quality and/or duration accompanied by associated night-time or daytime symptoms, occurring at least three nights per week for a minimum of three months (assessed by a score of <16 on the Sleep Condition Indicator).
Who cannot join
- Report active suicidal ideation and/or recent suicide attempts (measured via item 9 of the Patient Health Questionnaire-9);
- Are currently receiving, or have completed within the previous 6 months, CBTi or specific components (e.g., sleep restriction therapy, stimulus control, or cognitive therapy) delivered in a live or one-to-one format OR those who participated in the co-production workshop study to develop the intervention;
- Individuals who are currently receiving inpatient hospital treatment, or who are scheduled for inpatient hospital admission during the study intervention period;
- Individuals with severe pain that is poorly controlled and/or significantly interferes with the individual's ability to engage safely with the study intervention;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Acceptability of a CBT-based Insomnia Intervention for People With Secondary Breast Cancer: a Mixed Methods Randomized Control Trial
The purpose of this trial is to evaluate an intervention designed to improve insomnia and sleep in people living with secondary breast cancer. The study will assess whether the intervention is feasible and acceptable to deliver and participate in, and whether it may improve sleep and related outcomes.
The main questions the study aims to answer are:
Read more
- Is it feasible to recruit people with secondary breast cancer to take part in the trial?;
- Is the intervention feasible for people with secondary breast cancer to use and complete?;
- Is the intervention acceptable to participants?;
- Does the intervention improve sleep, fatigue, quality of life, and mental health?;
Participants will be allocated to one of two groups:
- Intervention group: Participants will be invited to attend five weekly sessions with a trained facilitator to receive the intervention.
- Control group: Participants will receive a Sleep Hygiene Education self-help resource to use over a five-week period.
Participants will complete questionnaires, sleep diaries, and sleep monitoring using a wearable device at three time points: before treatment, immediately after the five-week treatment period, and three months after treatment.
Participants will also be invited to provide feedback about their experiences of taking part in the study and the intervention through either an interview or survey.
The results will be used to determine whether the intervention is feasible and acceptable and whether there is evidence of potential benefits for sleep and other outcomes. The findings will help determine whether further research of the intervention is warranted and if there is further intervention development work required.
Read the detailed description
The primary aim of this project is to explore the feasibility and acceptability of a newly developed insomnia intervention based on Cognitive Behavioural Therapy for Insomnia (CBTi). CBTi is recommended as the gold standard treatment for insomnia (NICE, 2021). CBTi combines cognitive, behavioural, and educational strategies to improve sleep and can be tailored to individual needs. Feasibility outcomes will be assess including participant recruitment and retention rates, intervention fidelity, completion of outcome measures, and participant acceptability. The secondary aim is to investigate the preliminary effectiveness of the intervention compared with a sleep hygiene education (SHE) control group. Preliminary effectiveness outcomes will include changes in sleep, mental health, quality of life, and daily functioning.
The aim is to recruit 50 adults with secondary breast cancer who meet the screening criteria for insomnia disorder, based on a Sleep Condition Indicator (SCI) score of <16. Individuals will not be eligible if they are experiencing current suicidal ideation, recently completed psychological treatment for insomnia, have a prognosis of <6 months or experience severe pain that is poorly controlled. The investigators will adopt multiple routes to recruitment including direct contact with individuals who previously completed consented to being contacted about future research; via breast cancer specific charities and support organisations and social media, support groups, physical and digital posters, and word-of-mouth.
Participants will access the online form (via Qualtrics) that contains participant information sheet, eligibility screening form, where appropriate, they can complete the consent form and assessment questionnaire. For participants who are eligible and consent to take part, they will be randomly allocated to the intervention or the control group (n=25 in each arm).
After randomisation, participants will be sent an email with a link to complete a baseline (pre-intervention) assessment questionnaire, complete the sleep diary and wear an actigraphy device for 7 days prior to commencement of the treatment phase to record sleep and rest/activity rhythms. Participants in the intervention group will be invited to attend an onboarding session and the 5 weekly sessions. The sessions will be delivered by trained research facilitators in groups of up to 6 participants. The control group will be provided with the SHE resources and advised to put the changes in place over the subsequent 5-week period.
Two-weeks following the final session, and 3 months following the final session, all participants will be invited to complete the same questionnaires as during the baseline assessment, sleep diary and actigraphy device. Participants will be invited to participate in a semi-structured interview with the researcher, or to provide feedback via an online survey.
Interventions - Sleep hygiene education (SHE) will be delivered via a booklet that provides information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). Participants in the SHE condition will be instructed to implement the SHE advice over a 5-week period. SHE has successfully been used as a control condition in other trials evaluating CBTi and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to CBTi.
ESTABLISH better sleep- The intervention was developed by behavioural sleep medicine experts at the Strathclyde Sleep Centre in collaboration with key stakeholders, including individuals living with secondary breast cancer and healthcare professionals. Intervention development involved a co-production study consisting of three iterative workshops exploring preferred methods of delivery, adaptations to treatment components, and potential barriers and facilitators to implementation. The newly developed protocol was shared with stakeholders for feedback and piloted with 4 patient participants. This resulted in final refinements. The intervention is based on the core components of Cognitive Behavioural Therapy for Insomnia (CBTi), targeting the sleep-related behaviours and thoughts that contribute to the development and maintenance of insomnia. Components include sleep education and sleep hygiene, Sleep Restriction Therapy (SRT, referred to in this programme as sleep optimisation therapy), Stimulus Control, relaxation strategies, and cognitive techniques. The intervention has been specifically adapted for individuals living with secondary breast cancer. Key adaptations include a comprehensive assessment to consider condition, co-morbidities and treatment-related impacts and tailor content specifically to individual needs; additional content relating to fatigue management; monitoring of key symptoms including fatigue and pain; scheduled napping guidelines, and inclusion of relevant examples throughout. For sleep restriction therapy specifically, a minimum time in bed of 6 hours was selected to account for additional sleep need and treatment related side-effects. For titration of SRT, an 85% sleep efficiency threshold was considered optimal to increase the sleep window given potential need for extended time in bed. The intervention will be delivered in weekly group sessions, either online via videoconferencing software or in person at the University of Strathclyde. Groups will include up to 6 participants. The intervention programme will include: an onboarding session lasting approximately 20-30 minutes, 5 weekly treatment sessions, optional facilitator check-in at week 3, and home-based practice of behavioural techniques between sessions. Intervention materials will include PowerPoint presentations, participant workbooks, facilitator manuals, videos, and supporting resources for family members and healthcare professionals.
- Conditions
- Insomnia, Breast Cancer Metastatic Breast Cancer
- Being tested
- Sleep hygiene education, Cognitive behavioural therapy for insomnia (CBTi)
- Keywords
- Insomnia, Secondary breast cancer, Metastatic breast cancer, Cognitive Behavioural Therapy for Insomnia, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene educationBehavioural
Also called Sleep education
Participants in this group will receive a sleep hygiene education resource containing evidence-based advice regarding sleep habits, lifestyle factors, and sleep environment recommendations. Participants in the control condition will be asked to implement the advice over a 5-week period and will continue to complete sleep diaries, actigraphy monitoring, and outcome assessments at the same time points as the intervention group.
Cognitive behavioural therapy for insomnia (CBTi)Behavioural
The intervention was developed by behavioural sleep medicine experts at the Strathclyde Sleep Centre in collaboration with individuals living with secondary breast cancer and healthcare professionals. The intervention is based on the core components of CBTi targeting the sleep-related behaviours and thoughts that contribute to the development and maintenance of insomnia that were specifically adapted for secondary breast cancer patients. Components include sleep education and sleep hygiene, sleep restriction therapy, stimulus control, relaxation strategies, and cognitive techniques. The intervention will be delivered in 5 weekly sessions, by the research team. The intervention programme includes an onboarding session, 4 weekly sessions, an optional individual check-in at week 3 and involved home-based practice of behavioural components.
| Study group | Role | What they receive |
|---|---|---|
| Control group (SHE + TAU) | Active comparator | This arm will act as a control group with sleep hygiene education (SHE) + treatment as usual (TAU). Receives: Behavioral: Sleep hygiene education |
| Intervention group (CBTi + SHE + TAU) | Experimental | This arm will be the intervention group with cognitive behavioural therapy for insomnia (CBTi) + sleep hygiene education (SHE) + treatment as usual (TAU). Receives: Behavioral: Cognitive behavioural therapy for insomnia (CBTi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Recruitment feasibility will be assessed using data collected through an online recruitment/sign-up form, which includes the Participant Information Sheet (PIS), eligibility screening questionnaire, informed consent form, and assessment questionnaire. Enrolment data for all participants who provide informed consent will be used to assess feasibility of recruitment. Recruitment will be considered feasible where 80% of target achieved.
The form will also record the number of individuals who meet the eligibility criteria but do not enrol in the study after viewing the PIS and completing the screening questionnaire. Where provided, reasons for non-participation will also be recorded. This will allow recruitment rates and reasons for non-participation to be assessed.
Measured: At completion of the recruitment period (up to 9 months after recruitment initiation)
Participant retention
Retention will be assessed by determining the proportion of enrolled participants who remain in the study and complete all outcome assessments throughout the study period. A retention rate of at least 70% of enrolled participants will be considered the target.
Measured: At 3-month follow-up
Intervention fidelity - facilitator
Intervention fidelity will be assessed by examining facilitator adherence to the intervention protocol using a check-list. Facilitator adherence will be assessed in sampled sessions, with adherence defined as delivery of >80% of the specified intervention content.
Measured: 1 year study period
Intervention fidelity - participants
Participant engagement in the intervention group will be assessed by attendance at ≥2 of 4 intervention sessions (or review of session recordings) in the intervention group.
Measured: During the intervention phase through immediately post-intervention
Outcome measure completion
The aim of this study is to determine the feasibility of conducting a definitive randomised controlled trial. Therefore, this outcome will assess the feasibility of the outcome measures. Success will be defines as >70% of questionnaires and sleep diaries completed.
Measured: From baseline through 3-month follow-up
Acceptability of the intervention
Acceptability will be assessed through participant interviews and/or a feedback survey. The interview schedule and survey will assess seven components of intervention acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Interviews will likely include >15 participants from the intervention group and >5 from the SHE control. The remaining participants will be invited to provide feedback via a survey.
Measured: 2-4 weeks post-intervention
Secondary outcomes (6)
Change in insomnia severity
Insomnia Severity Index (ISI, Morin et al., 2011). The ISI is a 7-item measure that evaluates the severity of sleep disturbance during the past 2 weeks. Scores range from 0-21 with higher scores indicating greater insomnia severity.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in sleep outcomes
Data from sleep diaries and actigraphy.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in mental health [depression]
Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 (Kroenke, Spitzer \& Williams, 2001) is a 9-item validated measure for the use of identifying symptoms of depression based on the DSM-5 criteria. Scores range from 0-27, with a higher score indicating more severe depressive symptoms
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in mental health [anxiety]
Generalised Anxiety Disorders - 7 (GAD-7). The GAD-7 (Spitzer, Kroenke \& Williams, 2006) is a 7-item which measures the presence and severity of anxiety symptoms with the use of some DSM-5 criteria for Generalised Anxiety Disorder. Scores range from 0-21, with a higher score indicating more severe anxiety symptoms.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). This is a 13-item questionnaire measuring self-reported fatigue and its impact on daily activities and function. Each item is scored on a 5-point Likert-scale and scores range from 0 to 52, with lower scores indicating greater fatigue
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Change in Quality of Life
Functional Assessment of Cancer Therapy - Breast (FACT-B scale). The FACT-B (Hahn et al., 2015) is a questionnaire designed to asses quality of life in individuals with breast cancer. It is a 37-item measure with five subscales to evaluate wellbeing across the following domains physical, social, emotional, functional wellbeing, as well as additional breast-cancer specific items. Each item is scored on a 5 point Likert Scale (0 = not at all, 4 = very much), with total scores ranging from 0-148, and higher scores indicate better quality of life
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start24 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, block randomised (1:1) controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- Beatson West of Scotland Cancer Centre, NHS Lothian
- Responsible party
- Principal investigator, Leanne Fleming, University of Strathclyde
- Investigators
- Leanne Fleming, PhD, Principal investigator, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859098
- Sponsor's protocol ID
- UEC26/47
- Acronym
- ESTABLISH
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared with other researchers. Due to the small and specific participant population, sharing individual-level data may increase the risk of participant identification. Data will therefore be retained and managed in accordance with applicable ethical, confidentiality, and data protection requirements. Anonymised and/or aggregated data from the outcome measures may be made available to other researchers where appropriate, if this does not compromise participant confidentiality or allow individuals to be identified.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a CBT-based Insomnia Intervention for People With Secondary Breast Cancer: a Mixed Methods Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07859098
- Acronym / sponsor ID
- ESTABLISH / UEC26/47
- Conditions
- Insomnia, Breast Cancer Metastatic Breast Cancer
- Keywords
- Insomnia, Secondary breast cancer, Metastatic breast cancer, Cognitive Behavioural Therapy for Insomnia, CBT-I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Collaborators
- Beatson West of Scotland Cancer Centre, NHS Lothian
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate an intervention designed to improve insomnia and sleep in people living with secondary breast cancer. The study will assess whether the intervention is feasible and acceptable to deliver and participate in, and whether it may improve sleep and related outcomes.
The main questions the study aims to answer are:
- Is it feasible to recruit people with secondary breast cancer to take part in the trial?;
- Is the intervention feasible for people with secondary breast cancer to use and complete?;
- Is the intervention acceptable to participants?;
- Does the intervention improve sleep, fatigue, quality of life, and mental health?;
Participants will be allocated to one of two groups:
- Intervention group: Participants will be invited to attend five weekly sessions with a trained facilitator to receive the intervention.
- Control group: Participants will receive a Sleep Hygiene Education self-help resource to use over a five-week period.
Participants will complete questionnaires, sleep diaries, and sleep monitoring using a wearable device at three time points: before treatment, immediately after the five-week treatment period, and three months after treatment.
Participants will also be invited to provide feedback about their experiences of taking part in the study and the intervention through either an interview or survey.
The results will be used to determine whether the intervention is feasible and acceptable and whether there is evidence of potential benefits for sleep and other outcomes. The findings will help determine whether further research of the intervention is warranted and if there is further intervention development work required.
Detailed description
The primary aim of this project is to explore the feasibility and acceptability of a newly developed insomnia intervention based on Cognitive Behavioural Therapy for Insomnia (CBTi). CBTi is recommended as the gold standard treatment for insomnia (NICE, 2021). CBTi combines cognitive, behavioural, and educational strategies to improve sleep and can be tailored to individual needs. Feasibility outcomes will be assess including participant recruitment and retention rates, intervention fidelity, completion of outcome measures, and participant acceptability. The secondary aim is to investigate the preliminary effectiveness of the intervention compared with a sleep hygiene education (SHE) control group. Preliminary effectiveness outcomes will include changes in sleep, mental health, quality of life, and daily functioning.
The aim is to recruit 50 adults with secondary breast cancer who meet the screening criteria for insomnia disorder, based on a Sleep Condition Indicator (SCI) score of <16. Individuals will not be eligible if they are experiencing current suicidal ideation, recently completed psychological treatment for insomnia, have a prognosis of <6 months or experience severe pain that is poorly controlled. The investigators will adopt multiple routes to recruitment including direct contact with individuals who previously completed consented to being contacted about future research; via breast cancer specific charities and support organisations and social media, support groups, physical and digital posters, and word-of-mouth.
Participants will access the online form (via Qualtrics) that contains participant information sheet, eligibility screening form, where appropriate, they can complete the consent form and assessment questionnaire. For participants who are eligible and consent to take part, they will be randomly allocated to the intervention or the control group (n=25 in each arm).
After randomisation, participants will be sent an email with a link to complete a baseline (pre-intervention) assessment questionnaire, complete the sleep diary and wear an actigraphy device for 7 days prior to commencement of the treatment phase to record sleep and rest/activity rhythms. Participants in the intervention group will be invited to attend an onboarding session and the 5 weekly sessions. The sessions will be delivered by trained research facilitators in groups of up to 6 participants. The control group will be provided with the SHE resources and advised to put the changes in place over the subsequent 5-week period.
Two-weeks following the final session, and 3 months following the final session, all participants will be invited to complete the same questionnaires as during the baseline assessment, sleep diary and actigraphy device. Participants will be invited to participate in a semi-structured interview with the researcher, or to provide feedback via an online survey.
Interventions - Sleep hygiene education (SHE) will be delivered via a booklet that provides information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). Participants in the SHE condition will be instructed to implement the SHE advice over a 5-week period. SHE has successfully been used as a control condition in other trials evaluating CBTi and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to CBTi.
ESTABLISH better sleep- The intervention was developed by behavioural sleep medicine experts at the Strathclyde Sleep Centre in collaboration with key stakeholders, including individuals living with secondary breast cancer and healthcare professionals. Intervention development involved a co-production study consisting of three iterative workshops exploring preferred methods of delivery, adaptations to treatment components, and potential barriers and facilitators to implementation. The newly developed protocol was shared with stakeholders for feedback and piloted with 4 patient participants. This resulted in final refinements. The intervention is based on the core components of Cognitive Behavioural Therapy for Insomnia (CBTi), targeting the sleep-related behaviours and thoughts that contribute to the development and maintenance of insomnia. Components include sleep education and sleep hygiene, Sleep Restriction Therapy (SRT, referred to in this programme as sleep optimisation therapy), Stimulus Control, relaxation strategies, and cognitive techniques. The intervention has been specifically adapted for individuals living with secondary breast cancer. Key adaptations include a comprehensive assessment to consider condition, co-morbidities and treatment-related impacts and tailor content specifically to individual needs; additional content relating to fatigue management; monitoring of key symptoms including fatigue and pain; scheduled napping guidelines, and inclusion of relevant examples throughout. For sleep restriction therapy specifically, a minimum time in bed of 6 hours was selected to account for additional sleep need and treatment related side-effects. For titration of SRT, an 85% sleep efficiency threshold was considered optimal to increase the sleep window given potential need for extended time in bed. The intervention will be delivered in weekly group sessions, either online via videoconferencing software or in person at the University of Strathclyde. Groups will include up to 6 participants. The intervention programme will include: an onboarding session lasting approximately 20-30 minutes, 5 weekly treatment sessions, optional facilitator check-in at week 3, and home-based practice of behavioural techniques between sessions. Intervention materials will include PowerPoint presentations, participant workbooks, facilitator manuals, videos, and supporting resources for family members and healthcare professionals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, block randomised (1:1) controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group (SHE + TAU) | Active comparator | Behavioral: Sleep hygiene educationThis arm will act as a control group with sleep hygiene education (SHE) + treatment as usual (TAU). |
| Intervention group (CBTi + SHE + TAU) | Experimental | Behavioral: Cognitive behavioural therapy for insomnia (CBTi)This arm will be the intervention group with cognitive behavioural therapy for insomnia (CBTi) + sleep hygiene education (SHE) + treatment as usual (TAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of secondary breast cancer;
- Have a prognosis of greater than 6 months;
- Be aged 18 years or over;
- Be willing and able to provide informed consent;
- Meet screening criteria for chronic insomnia, defined as dissatisfaction with sleep quality and/or duration accompanied by associated night-time or daytime symptoms, occurring at least three nights per week for a minimum of three months (assessed by a score of <16 on the Sleep Condition Indicator).
Key exclusion criteria (4 listed)
- Report active suicidal ideation and/or recent suicide attempts (measured via item 9 of the Patient Health Questionnaire-9);
- Are currently receiving, or have completed within the previous 6 months, CBTi or specific components (e.g., sleep restriction therapy, stimulus control, or cognitive therapy) delivered in a live or one-to-one format OR those who participated in the co-production workshop study to develop the intervention;
- Individuals who are currently receiving inpatient hospital treatment, or who are scheduled for inpatient hospital admission during the study intervention period;
- Individuals with severe pain that is poorly controlled and/or significantly interferes with the individual's ability to engage safely with the study intervention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep hygiene educationAlso: Sleep educationParticipants in this group will receive a sleep hygiene education resource containing evidence-based advice regarding sleep habits, lifestyle factors, and sleep environment recommendations. Participants in the control condition will be asked to implement the advice over a 5-week period and will continue to complete sleep diaries, actigraphy monitoring, and outcome assessments at the same time points as the intervention group. | Behavioural | Control group (SHE + TAU) |
| Cognitive behavioural therapy for insomnia (CBTi)The intervention was developed by behavioural sleep medicine experts at the Strathclyde Sleep Centre in collaboration with individuals living with secondary breast cancer and healthcare professionals. The intervention is based on the core components of CBTi targeting the sleep-related behaviours and thoughts that contribute to the development and maintenance of insomnia that were specifically adapted for secondary breast cancer patients. Components include sleep education and sleep hygiene, sleep restriction therapy, stimulus control, relaxation strategies, and cognitive techniques. The intervention will be delivered in 5 weekly sessions, by the research team. The intervention programme includes an onboarding session, 4 weekly sessions, an optional individual check-in at week 3 and involved home-based practice of behavioural components. | Behavioural | Intervention group (CBTi + SHE + TAU) |
Primary outcome
Participant recruitment
Time frame: At completion of the recruitment period (up to 9 months after recruitment initiation)
Recruitment feasibility will be assessed using data collected through an online recruitment/sign-up form, which includes the Participant Information Sheet (PIS), eligibility screening questionnaire, informed consent form, and assessment questionnaire. Enrolment data for all participants who provide informed consent will be used to assess feasibility of recruitment. Recruitment will be considered feasible where 80% of target achieved. The form will also record the number of individuals who meet the eligibility criteria but do not enrol in the study after viewing the PIS and completing the screening questionnaire. Where provided, reasons for non-participation will also be recorded. This will allow recruitment rates and reasons for non-participation to be assessed.
Participant retention
Time frame: At 3-month follow-up
Retention will be assessed by determining the proportion of enrolled participants who remain in the study and complete all outcome assessments throughout the study period. A retention rate of at least 70% of enrolled participants will be considered the target.
Intervention fidelity - facilitator
Time frame: 1 year study period
Intervention fidelity will be assessed by examining facilitator adherence to the intervention protocol using a check-list. Facilitator adherence will be assessed in sampled sessions, with adherence defined as delivery of >80% of the specified intervention content.
Intervention fidelity - participants
Time frame: During the intervention phase through immediately post-intervention
Participant engagement in the intervention group will be assessed by attendance at ≥2 of 4 intervention sessions (or review of session recordings) in the intervention group.
Outcome measure completion
Time frame: From baseline through 3-month follow-up
The aim of this study is to determine the feasibility of conducting a definitive randomised controlled trial. Therefore, this outcome will assess the feasibility of the outcome measures. Success will be defines as >70% of questionnaires and sleep diaries completed.
Acceptability of the intervention
Time frame: 2-4 weeks post-intervention
Acceptability will be assessed through participant interviews and/or a feedback survey. The interview schedule and survey will assess seven components of intervention acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Interviews will likely include >15 participants from the intervention group and >5 from the SHE control. The remaining participants will be invited to provide feedback via a survey.
6 secondary outcomes
Change in insomnia severity
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in sleep outcomes
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in mental health [depression]
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in mental health [anxiety]
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in fatigue
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Change in Quality of Life
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Strathclyde Sleep Centre websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared with other researchers. Due to the small and specific participant population, sharing individual-level data may increase the risk of participant identification. Data will therefore be retained and managed in accordance with applicable ethical, confidentiality, and data protection requirements. Anonymised and/or aggregated data from the outcome measures may be made available to other researchers where appropriate, if this does not compromise participant confidentiality or allow individuals to be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leanne Fleming, PhD principal investigator
University of Strathclyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene education and Cognitive behavioural therapy for insomnia (CBTi) in people with Insomnia and Breast Cancer Metastatic Breast Cancer, run by University of Strathclyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie McCrory, PhD (07538376660, stephanie.mccrory@strath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: At completion of the recruitment period (up to 9 months after recruitment initiation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.