A study looking at mindfulness as a way of helping with fatigue, anxiety and depression in women who have secondary breast cancer

Please note this trial is no longer recruiting patients.

This study is looking at a form of meditation called mindfulness as a way of reducing stress. It is for women who have breast cancer that has spread to other parts of the body (secondary breast cancer).

Many women with secondary breast cancer feel tired and lack energy. This is called fatigue. Some also feel anxious or depressed. In this study, researchers are trying to find out if a programme that teaches mindfulness can help with these problems.

Mindfulness aims to increase your awareness of the present moment. If you are able to worry less about the past and the future, it may help to reduce stress.

If you take part in this study, you join an 8 week programme. You have mindfulness training in group sessions each week. You will also need to practice at home every day.

The aims of the study are to

Find out if the mindfulness programme is acceptable to people
See whether it would be possible to run a randomised trial to study this more

Recruitment

Start 06/10/2010

End 06/12/2011

Phase

Other

Who can enter

You can enter this study if both the researcher and your cancer specialist think you would be eligible and you

Were diagnosed with secondary breast cancer at least 2 months ago
Are well enough to take part in the programme and are up and about for at least half the day (performance status 0, 1 or 2)
Can speak, read and write English fluently

Trial design

This study will recruit about 30 women who have secondary breast cancer.

If you are invited to join the study, you start by having a phone conversation with the person who will teach you mindfulness meditation (the instructor). If you are happy to go ahead, you join an 8 week programme. You have a group session every week.

Each session includes time spent focusing on your body and being aware of your breathing. There is also some gentle stretching.

During the study, you also practice mindfulness meditation at home each day. This takes between 10 minutes and half an hour. The instructor will give you a CD to use. They will ask you to keep a record of your practice at home and they will ask you how ‘mindful’ you think you are in the course of your daily activities.

The study team will ask you to complete some questionnaires during the study. These will ask about how tired you have been feeling, how anxious or depressed you feel and about your general well being.

Before you start the sessions, a member of the study team will interview you and ask what you expect from the programme. About 4 months after you finish the programme, you have another interview so they can ask you about your experience of it.

They will offer you a session by phone to talk about any difficulties you have.

Hospital visits

You have 9 group sessions over an 8 week period. They are usually 2 hours long, but the first and last class will be slightly longer. And in the 6th week, there is an extra session that will last for 4 or 5 hours.

The interviews you have before and after the programme take between 30 minutes and an hour each time.

Your practice at home takes up to half an hour each day.

Side effects

There are no side effects associated with this study, but some people may feel frustrated during the group sessions if they find their mind wanders. You may find it a bit stressful to include mindfulness practice every day, and some people may find it uncomfortable to sit during meditation. If this does happen, the instructor will encourage you to change position.

Some people may find it upsetting to talk about certain issues in the interviews or to answer questions about them in the questionnaires. You do not have to answer any questions you don’t want to and the study team will offer you more support if you need it.