In Spring 2024, Make 2nds Count awarded £186,500 across three years to a research study project run by Dr Leanne Fleming to look at the impacts of insomnia in secondary breast cancer patients. The study hopes to demonstrate the effectiveness of Cognitive Behavioural Therapy (CBT) as a tailored insomnia intervention for those living with the disease.
On National Sleep Day (14 March), we are launching the first stage of this research study where we will be asking our community to complete a survey about their sleeping habits and the impact of insomnia on their daily lives.
In previous insomnia studies, Cognitive Behavioural Therapy (CBT) is the NICE recommended first-line treatment for both short and long-term insomnia in adults of all ages. Secondary breast cancer patients have been excluded from previous studies and so it remains unknown if CBT could be a feasible, acceptable or effective treatment in this patient population. This research study, known ESTABLISH (Exploring Suitable Treatments for Advanced Breast cancer patients with Long-term Insomnia through StakeHolder collaboration), aims to close this knowledge gap.
The Chief Investigator of this study is Dr Leanne Fleming, Reader in Psychology and Director of the Centre for Sleep Health at the University of Strathclyde, Glasgow who explains the importance of this study in our short film below.
Study Background
Insomnia is a public health issue that is just as important as physical health and diet. Around 18-20% of people with breast cancer have persistent trouble in falling and/or staying asleep. It can negatively affect quality of life and leads to other mental and physical health problems.
As secondary breast cancer patients have been excluded from previous studies on insomnia, it is important that the ESTABLISH research study takes place. It is hypothesized that tailored insomnia intervention for secondary breast cancer patients would be of benefit.
Study Aims
Over the next three years, we hope this study will inform the development and evaluation of an insomnia intervention for secondary breast cancer patients that will deliver tangible near-time patient benefits. The aims of this study are:
Aim 1: Co-production of a tailored insomnia intervention
By undertaking a multi-stakeholder process, a tailored insomnia intervention for patients with secondary breast cancer will be developed. This will be done through the patient survey, interactive workshops and working groups involving patients, carers and healthcare professionals. A programme of training workshops for healthcare professionals will also be implemented to facilitate the delivery of the CBT intervention.
Aim 2: Evaluation of feasibility and preliminary effectiveness of a tailored insomnia intervention
A mixed-methods pilot Randomised Control Trial (RCT) will be conducted to assess the feasibility and preliminary effectiveness of the tailored CBT intervention against a sleep education control intervention. Secondary breast cancer patients will be recruited from across two study sites in Scotland (the NHS Greater Glasgow and Clyde and NHS Lothian regions). The study aims to recruit 25 patients into each study group and the results are anticipated to lay the foundation for a future UK-wide RCT.