Not yet recruitingNAINTERVENTIONAL

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

This study is testing a new programme designed to help people with secondary breast cancer who have trouble sleeping. Many people living with secondary breast cancer find it hard to get a good night's rest, which can affect their daily life and mood. This programme uses a type of talking therapy to help improve sleep. Researchers want to find out if this programme is practical, acceptable, and if it makes a real difference to sleep quality, energy levels, and overall well-being. Participants will either try the new sleep programme or receive a guide on healthy sleep habits. They'll share their experiences through questionnaires and sleep monitors to help us understand if this new treatment is worth developing further.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Strathclyde

Enrolment target

Start

24 Sep 2026

Estimated completion

31 Dec 2027

Insomnia Breast Cancer Metastatic Breast Cancer

What is this study about?

This research study is looking for better ways to help people living with secondary breast cancer who also experience insomnia (trouble sleeping). Secondary breast cancer means the cancer has spread to other parts of the body. We know that getting a good night's sleep is incredibly important for everyone, but it can be particularly challenging when you're living with cancer. Persistent sleep problems can make you feel tired, affect your mood, and impact your overall quality of life.

The main goal of this study is to test a new programme that teaches skills and techniques to improve sleep. This programme is based on a well-known therapy called 'Cognitive Behavioural Therapy for Insomnia', often shortened to CBT-I. It's about changing thoughts and behaviours that get in the way of good sleep. We want to find out if this new approach is practical, easy for people to use, and if it genuinely helps people sleep better, feel more energetic, and improve their general well-being.

By taking part, you would help us understand if this new sleep programme is effective and suitable for people with secondary breast cancer. Your experiences will help decide if this treatment should be offered more widely in the future to help others facing similar challenges. We're looking for about 50 people to join this study.

Key takeaways

This study explores a new, non-drug treatment for sleep problems in people with secondary breast cancer.
It aims to improve sleep quality, energy, and overall well-being.
The new programme is based on talking therapy (CBT-I) to help you learn sleep-improving skills.
You will either join the new programme or receive a guide on healthy sleep habits.
Participation involves weekly sessions (for one group), questionnaires, and wearing a sleep monitor.
Your involvement could help future patients with secondary breast cancer struggling with sleep.

Who may be eligible?

To be considered for this study, you need to have a diagnosis of secondary breast cancer and be at least 18 years old. Importantly, you should also be experiencing ongoing trouble sleeping, which has lasted for at least three months, at least three nights a week. The study will check your sleep habits to see if they fit the criteria for chronic insomnia.

There are a few reasons why someone might not be able to join. For example, if you've recently had therapy specifically for insomnia (like CBT-I) in the last six months, or if you're currently having thoughts of self-harm, this study might not be suitable. We also can't include people who are in hospital or are expected to be in hospital during the study period, or if you have severe pain that isn't under control and might make it hard to take part.

The research team will carefully check these points with you to make sure the study is a good fit and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have secondary breast cancer?
Are you 18 years old or older?
Do you regularly struggle to fall or stay asleep, at least 3 nights a week for 3 months or more?
Have you *not* recently (in the last 6 months) had specific talking therapy for insomnia?
Are you able to attend weekly sessions or use an online guide for 5 weeks?
Is your pain generally well-managed?

Answer every question to see your result.

What does participation involve?

If you decide to take part and are eligible, you'll be randomly assigned to one of two groups, like flipping a coin. One group will take part in the new sleep programme, which involves attending five weekly sessions with a trained facilitator. These sessions are designed to teach you skills to improve your sleep.

The other group will receive a helpful guide on healthy sleep habits to use on your own over the same five-week period. Regardless of your group, you'll be asked to complete some questionnaires, keep a sleep diary, and wear a special device to monitor your sleep. You'll do this three times: once at the start, once right after the five-week period, and again three months later. Some participants will also be invited to share their experiences through an interview or survey. The total time you're actively involved in the study will be about five weeks, plus the follow-up three months later.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as learning new ways to manage your sleep problems, which might lead to improved sleep, more energy, and a better mood. You would also be contributing valuable information that could help others with secondary breast cancer in the future. As with any study, there might be some minor inconveniences, like the time it takes to complete questionnaires or attend sessions. The study has been designed to be as safe and comfortable as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Strathclyde
Verified postcode
Glasgow, United Kingdom

Common questions

What is 'secondary breast cancer'?

Secondary breast cancer is when breast cancer cells have spread from the breast to other parts of the body, like the bones, liver, or lungs.

What is 'insomnia'?

Insomnia means you regularly have trouble falling asleep, staying asleep, or wake up too early and can't get back to sleep, leading to tiredness during the day.

What is CBT-I?

CBT-I stands for 'Cognitive Behavioural Therapy for Insomnia'. It's a type of talking therapy that teaches you skills to change thoughts and habits that prevent you from sleeping well.

Will I have to take any new medications?

No, this study is looking at a non-medication approach to improving sleep. You will not be asked to take any new drugs.

How long will the study last for me?

Your active participation, including sessions or using the guide, will last for five weeks, with follow-up checks three months later.

How to find out more

Stephanie McCrory, PhD

stephanie.mccrory@strath.ac.uk 07538376660 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.