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Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
Sponsor: University of Strathclyde
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. 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.
Official title: Feasibility and Acceptability of a CBT-based Insomnia Intervention for People With Secondary Breast Cancer: a Mixed Methods Randomized Control Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-09-24
Completion Date
2027-12-31
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
Sleep hygiene 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)
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.
Locations (1)
University of Strathclyde
Glasgow, United Kingdom