NCT07859098Not yet recruiting
Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
Feasibility and Acceptability of a CBT-based Insomnia Intervention for People With Secondary Breast Cancer: a Mixed Methods Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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: 1. Is it feasible to recruit people with secondary breast cancer to take part in the trial?; 2. Is the intervention feasible for people with secondary breast cancer to use and complete?; 3. Is the intervention acceptable to participants?; 4. Does the intervention improve sleep, fatigue, quality of life, and mental health?; Participants will be allocated to one of two groups: 1. Intervention group: Participants will be invited to attend five weekly sessions with a trained facilitator to receive the intervention. 2. 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Strathclyde
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07859098
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 24 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- Report active suicidal ideation and/or recent suicide attempts (measured via item 9 of the Patient Health Questionnaire-9);
- Individuals with severe pain that is poorly controlled and/or significantly interferes with the individual's ability to engage safely with the study intervention;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Strathclyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.