“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A study to develop a decision making aid about genetic testing for breast cancer (YoDA BRCA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at developing a Decision Aid to help women decide about having genetic testing for breast cancer.
More about this trial
Genetic testing to find whether someone has an inherited increased risk of developing breast cancer is available to some groups of people. Particularly for women who have been diagnosed at a young age.
In this study the researchers want to understand the experiences of younger women who may be eligible for genetic testing at diagnosis. They also want to find out what information they feel is valuable in making the decision to have genetic testing at this time.
The team will gather this information by inviting you to either an interview, focus group or a session to try out an early version of the Decision Aid.
The aim of this study is to develop a Decision Aid to help women decide if genetic testing is right for them and when should they have it done.
Who can enter
You may be able to join this study if you are a woman between 18 and 50 years old who has been diagnosed with breast cancer in the past 18 months.
You cannot join this study if you have breast cancer that
- Has come back in the same place (local recurrence)
- Had already spread to another part of your body when you were diagnosed
The researchers need 90 women to join.
You may receive a letter inviting you to take part or your doctor may mention the study to you when you see them in the clinic. You will receive a pack that explains about the study and a short questionnaire. You need to complete the questionnaire and return it to the study team. The study team will use the questionnaire to determine which part of the study you are most suited for. You can also request which part you’d prefer to take part in.
The researchers want women who have a wide range of treatments and experiences. So although you have expressed an interest in the study the team may not select you to take part.
There are 2 parts to this study. In the first part the team will interview 30 women. They will ask about
- Your views and understanding of genetic testing for breast cancer
- Information that you think might be, or was, important to help you make the decision about having the test
- What you think a web based Decision Aid might consist of
If you have had genetic testing, the study team will focus on
- What you felt was done well
- What you found most helpful
- What could be improved
With your permission the interview will be audio recorded.
In the 2nd part of the study you may be asked to take part in a focus group or a think aloud session.
The researchers need 40 women to join the focus groups. There will be 5 groups with about 8 women in each. You will be given materials about genetic testing and the team will ask you about what information you find important and useful and discuss how it could be best presented.
For the think aloud session, the team need up to 20 women. They will ask you to test the Decision Aid and give feedback about it. They will also ask where and how you would prefer to use it for example at home or in the hospital, by yourself or with a member of the family or a friend or with the help of a health care professional.
The team will also invite 15 health care professionals to join a group to look at the Decision Aid and advise on the information provided.
For the interviews a member of the team can arrange to see you at your home, at the University of Southampton or the Southampton University Hospital. If it is more convenient they can arrange to phone you or go online using Skype.
The focus groups and the think aloud session will take place in 2016. If you are asked to take part, the study team will contact you nearer the time.
There are no side effects if you take part in this study.
How to join a clinical trial
Prof Claire Foster
Breast Cancer Now
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton