“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study to find out what people with breast cancer think of mindfulness and whether a course to teach it can be adapted to meet their needs (MABCan study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is trying to find out what women with breast cancer think of a meditation technique called mindfulness. The researchers are also looking at designing a mindfulness course specifically for people with breast cancer.
Mindfulness involves learning techniques that help you focus or live in the moment. This can help you to manage difficult experiences and feelings such as fear and anxiety.
Usually, a course to teach the techniques of mindfulness meditation lasts for 8 weeks. This can be a considerable commitment for women who are working or have children, or who may be going to hospital for regular treatment. So in this study, researchers want to find out if they can adapt the standard mindfulness course to suit the needs of breast cancer patients.
There are 2 parts to the study. The researchers aim to
- Find out what women with breast cancer understand about mindfulness, whether they would be interested in this type of mediation and what they think about learning the technique
- Work out how they would need to change the 8 week mindfulness course to make it more suitable for women with breast cancer
- See what people think of an adapted course design
Who can enter
You cannot volunteer to take part in this study. You may be asked to take part if you have breast cancer, have had treatment at University Hospital Southampton and the following apply
- If you have early stage breast cancer, it must be a least a month since your final chemotherapy or radiotherapy treatment
- If you have secondary breast cancer, it must be at least 2 months since this was diagnosed and your breast cancer mustn’t be getting any worse
- You have some degree of anxiety or depression (the researchers use questionnaires to assess this)
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You cannot join this study if you
- Have a mental health problem that the study team think could affect you taking part
- Don’t speak English
The study is in 2 parts. The researchers need about 30 women to join the 1st part. They need between 5 and 10 of these women to join the 2nd part too.
If you join the 1st part of the study, the researchers will ask you to take part in a focus group with up to 6 other women. They want to find out peoples’ views and opinions about mindfulness meditation techniques.
As you may not know what the techniques are, the researcher will play a short CD or DVD describing mindfulness and ask you to do a brief mindfulness exercise first. They will then ask for your opinions.
If you don’t want to take part in a focus group but are interested in offering your views on mindfulness, you can have a one to one interview with a researcher instead. This will be similar to the focus group, starting with a short CD to describe mindfulness and a brief exercise to do.
The study team will ask if you would also be interested in joining the 2nd part of the study. In this part, they want to interview between 5 and 10 women to see what they think of how the researchers adapt the mindfulness course to meet the needs of women with breast cancer.
If you take part, you have another interview with a researcher. They will ask for your feedback on the adapted course. This will help them to improve the design.
The researchers will make an audio recording of the focus groups and any interviews. But it will not be possible to identify you in any results from the study.
If you take part in a focus group, it will last between 1 and 2 hours. It will take place in a suitable room at the hospital, or at another location that is easily accessible and has plenty of parking.
If you have an interview in the 1st part of the study, it will take between 45 minutes and an hour.
If you join the 2nd part of the study, the interview will take about half an hour.
The interviews will take place in a suitable room at the hospital, or in your home if you prefer.
There are no side effects from taking part in this study.
How to join a clinical trial
Dr Caroline Eyles
Breast Cancer Campaign
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton