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A pilot randomised controlled trial of sleep restriction therapy versus sleep hygiene education for newly diagnosed breast cancer patients with acute insomnia

Funder: Chief Scientist Office (CSO) (£300k)
Project duration: 2023-2025
Principal Investigator: Dr Leanne Fleming, University of Strathclyde
Collaborating Institutions: University of Oxford, University of Glasgow, University of Aberdeen

Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia. Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake.
Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education control intervention. We will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study.
Throughout, we will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.
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