“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study looking at a way of identifying women who are at increased risk of breast cancer due to a family history
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is developing a method to help GPs identify women at an increased risk of breast cancer due to their family history.
The National Institute for Health and Care Excellence (NICE) has produced guidelines that identify family histories which could increase your risk of breast cancer. But some women with a high risk are not being identified. Other women who have an average risk are being referred to specialist services when they don’t need to be.
The aim of this study is to develop a more systematic way of identifying a woman’s risk and managing her care according to the national guidelines. The researchers want to see if their method could work in primary care and whether it would be acceptable to GPs.
Who can enter
You may be asked to join this study if you are registered at a GP practice that is taking part and you
- Are a women aged between 30 and 60
- Are able to complete the questionnaires in English
You cannot join this study if any of these apply. You
- Have had breast cancer or ovarian cancer
- Have had an assessment of your risk of breast cancer due to family history at a specialist breast cancer clinic in the last year
- Took part in a focus group in an earlier phase of this study
There will be 12 GP practices taking part in this study. They are put into 1 of 2 groups at random.
Practices in the first group will send out family history questionnaires to women who are eligible to join the study. They may also ask women to join if they visit their GP to discuss breast cancer symptoms or a history of breast cancer in their family, or during a consultation where family history may be collected. As well as the family history questionnaires, they will send an information sheet about the study, a questionnaire about the study, a consent form and a stamped addressed envelope for you to return the questionnaires and consent form.
Practices in the other group won’t send out family history questionnaires. They may ask you to join the study if you visit your GP to discuss breast cancer symptoms or a history of breast cancer in your family or during a consultation where family history may be collected. If you agree to take part, they will give you an information sheet, a study questionnaire, a consent form and a stamped addressed envelope to return the questionnaire and consent form.
If you do complete and send back a family history questionnaire, the information you provide will be entered onto a computer at your GP practice. Your GP will see your assessed risk of breast cancer.
In line with the national guidelines, if you are at an average risk based on your family history, your GP will send you information about lifestyle factors that can affect your breast cancer risk and information about examining your breasts.
If you are at a moderate or high risk based on your family history, they will ask to see you to discuss whether you should be referred to a specialist breast clinic for assessment.
The questionnaires asking you about the study will be reviewed by the research team at the University of Nottingham.
The study team will send everybody 2 more questionnaires asking about the study 2 weeks and 6 months later. They will include stamped addressed envelopes for you to return them by post. They will ask permission to collect information from your medical notes for up to 8 months.
Taking part in this study does not involve any hospital visits as you fill in the questionnaires at home. But you may have a hospital visit if you are found to have a moderate or high risk.
The researchers will ask women who filled out a family history questionnaire if they would be willing to take part in an interview at the end of the study. You don’t have to agree to this if you don’t want to.
They hope to interview about 30 women who have filled in questionnaires. They will also interview some of the staff at the GP practices involved in the study.
If you do take part in an interview, it will last about 30 minutes.
Some people may find it worrying to think about illnesses that run in their family. The research team or your doctor can help you if you have any concerns.
How to join a clinical trial
Professor Nadeem Qureshi
NIHR Clinical Research Network: Cancer
NIHR Clinical Research Network: East Midlands
NIHR School for Primary Care Research
University of Nottingham