A novel approach to sleep ‘prehabilitation’ is to be trialled with newly-diagnosed breast cancer patients suffering from early signs of insomnia, in research by the University of Strathclyde and the NHS.
The pilot study will examine the use of Sleep Restriction Therapy, which helps to improve nighttime sleep by stabilising patterns and reducing time spent awake in bed.
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 who are displaying early signs of insomnia and are undergoing cancer treatment.
Researchers at Strathclyde, with partners at NHS Grampian and NHS Greater Glasgow and Clyde, are aiming to recruit 40 patients to participate in the study which, if successful, could be expanded to a full-scale insomnia prehabilitation trial
A treatment group of patients will receive the therapy, delivered during their cancer treatment by breast cancer research nurses. The control group will have a course of ‘sleep hygiene education,’ which focuses on various practices designed to enhance the quality of sleep.
One fifth of breast cancer survivors have insomnia. Sleep difficulties often begin at the time of diagnosis and can become worse during cancer treatment, continuing long into cancer survival. This prehabilitation approach has the potential to prevent early sleep disturbance developing into a chronic problem.
The two-year study, named INVEST (Investigating the Value of Early Sleep Therapy) is led by Dr Leanne Fleming, Director of the Strathclyde Centre for Sleep Health, who has received funding of £299,058 from the Scottish Government’s Chief Scientist Office.
The NHS Grampian team involved in the study received the National Institute for Health Research's CREST Award for its work in 2023.
Dr Solveiga Zibaite, study Research Associate in Strathclyde’s Department of Psychological Sciences & Health, said: “Insomnia disorder is the most commonly reported mental health complaint amongst people with cancer, and breast cancer patients report the highest rate of poor sleep.
“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.
“This study aims to explore the feasibility of early sleep intervention to avert insomnia disorder in breast cancer patients. It will address the knowledge gap in using Sleep Restriction Therapy for new breast cancer patients; we will do this by randomly assigning newly diagnosed patients with poor sleep to receive either the therapy or a sleep hygiene education control intervention.
“We’ll assess sleep and mental health before and after the interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients. Throughout, we will work with patients with experience of breast cancer and poor sleep, to ensure our study is informed by their expertise.
The aim of this therapy is to ensure that patients sleep well, and don’t spend long periods lying in bed awake.
“We also want to help patients regain some control over their lives, something which cancer patients can feel they lose during treatment.”
Consultant breast surgeon Miss Beatrix Elsberger and her team are supporting the study among NHS Grampian patients. She said: "Improving patient outcomes by supporting studies like this one is an invaluable part of our work in the NHS.
“My team was recognised last year for making the greatest contribution to clinical trials research across the UK and we are proud to have a high-quality clinical research environment for cancer trials in Aberdeen."
Previous research by Strathclyde’s Centre for Sleep Health, of which Dr Zibaite is a member, found that 46% of newly diagnosed breast cancer patients develop acute insomnia following diagnosis. Rates of insomnia remain stable and pervasive for at least 12 months after diagnosis, indicating that acute insomnia can become chronic if not addressed.
The Centre has also found that breast cancer patients implement sleep extension behaviours, which are intended to compensate for sleep loss but actually increase risk of insomnia disorder.
The study opens for recruitment in April 2024. Further information can be obtained from Dr Zibaite.