Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.

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.