Sleep Well At Night

Research has shown that the incidence of sleep disturbances in people with cancer is much higher than in the general population. Sleep problems can lead to worse symptoms, quality of life, and potentially impact outcomes. The most common treatment of sleep disturbances is medication which often comes with unwanted side-effects and risk. This study aims to test whether a non-drug intervention can be given to people with cancer to help with sleep disturbances. The study will take place over 8-weeks. The first and final week of the study involves assessments (further described below) while the intervention will take place over weeks 2-7. The intervention involves an online cognitive behavioural therapy course, daily bright light therapy and engaging with an activity plan. The initial review aims to identify any reversible causes of the sleep disturbance, including reviewing uncontrolled symptoms and medications. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to be effective at improving the time it takes for people to fall asleep and reducing the amount of time you wake up in the night. Light therapy mimics our natural exposure to sunlight. Light exposure may help to improve sleep during the night, mood, and activity or attention levels during the day. Physical activity levels will also be reviewed. Interests and barriers to activity will be discussed and goals will be set for activity. This will be reviewed weekly. Questionnaires will be completed in the first and final week of the study to assess sleep, symptoms and quality of life. Wrist actigraphy, thigh accelerometry and a sleep diary will also be used on the first and final week of the study to assess sleep, activity and subjective sleep patterns.

NCT Number	NCT07068971
Lead Sponsor	Our Lady's Hospice and Care Services Collaborators: St Vincent's University Hospital, Ireland
Conditions	Sleep Disturbance in Advanced Cancer
Enrollment	30 participants
Start Date	2024-08-19
Primary Completion	2025-08-24 (estimated)
Study Completion	2025-08-24 (estimated)
Updated on ClinicalTrials.gov	2025-07-16