A study looking at assessing breast cancer risk in GP practices (CanRisk-GP)
Cancer type:
Status:
Phase:
This study is looking at whether using the CanRisk assessment tool in a GP practice is useful. This tool works out a woman’s risk of developing breast cancer.
It is for women who are registered at GP practices in Cambridgeshire and Peterborough.
You can’t volunteer to take part in this research. You will get a letter inviting you to join.
This study is supported by Cancer Research UK.
More about this trial
Some women have an increased risk of developing breast cancer. For women aged 30 or over who have an increased risk, there are options available to reduce this risk. These include making changes to their lifestyle, earlier breast cancer screening and medication. And there is screening for those at an increased risk to help find any cancers that do develop early. Screening aims to find cancers early, when they have the best chance of being successfully treated.
Some women learn about their increased risk of developing breast cancer because they have a family history of breast cancer.
Women who do not have a family history or do not know that having a family history can increase their risk, won’t know if they have an increased risk of developing breast cancer. So they are missing out on the possible ways to reduce this risk.
CanRisk is an online tool. It helps healthcare professionals work out an individual's future risk of developing breast and ovarian cancer. It looks at several factors including:
- family history
- genetic test results
- lifestyle factors such as weight, smoking and alcohol use
- whether you take an oral contraceptive pill and for how long
- whether you take hormone replacement therapy (HRT) and for how long
CanRisk is used in specialist genetic clinics with women who are known to have an increased risk of breast cancer. It is not used routinely in GP surgeries.
In this study, the team are asking some women between the ages of 40 and 49 and registered with participating GP practices to complete a CanRisk assessment. This is to work out their risk of developing breast cancer. Women who have an increased risk will then be advised to contact their GP to talk about reducing their risk. If suitable, they will be referred for specialist care at the Clinical Genetics Service in Addenbrooke’s Hospital Cambridge. This is to see if they are eligible for earlier screening or medication.
The main aim of this 
is to see:
- if inviting women to have their risk of breast cancer assessed using the CanRisk tool through GP surgeries is possible and
- if it is acceptable to women and GPs
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- are female
- are between 40 and 49 years old
- are registered with a GP that is taking part in the study
- can speak English well
Who can’t take part
You cannot join this study if any of these apply. You:
- have had breast cancer or ovarian cancer in the past
- have an inherited cancer gene that means you have a high risk of developing cancer or a family member with one of the inherited cancer genes
- have cancer that has spread to another part of the body or you are having
palliative treatment - have already let your GP know you don’t want to take part in any research projects
- can’t give
informed consent for any reason
Trial design
The team will send letters to about 5,000 women inviting them to take part in the study. They hope that about 1,000 will agree to join. If you agree, you fill in a questionnaire. This is sent to you as a link in an email.
The questionnaire asks about:
- you and your background
- your thoughts about breast cancer and the risk of developing it
- your health and wellbeing
It will take about 20 minutes to complete.
CanRisk tool
You are sent a link to the CanRisk data collection tool, called MyCanRisk. You fill it in online. It asks about you and your family. This information is used to work out your risk of developing breast cancer. It might take about 30 minutes or more to answer the questions, depending on how many there are in your family.
Gene testing
The team will ask you if you would like to provide a spit (saliva) sample. This is to look for gene changes (). It helps the team to work out your risk of developing breast cancer more accurately. If you agree to give the sample, the team will post you a kit to take the sample. The kit will contain instructions on how to do it and a stamped addressed envelope to return the sample. The team send the sample to a laboratory for genetic testing.
Getting your test results
You will get your results by email within 16 weeks of joining the study.
Most women joining the study won’t have an increased risk of developing breast cancer. If this applies to you, you get your CanRisk report and a results letter including breast awareness information. You will not need to see the GP.
Some women will have an increased risk of developing breast cancer. You will get your CanRisk report and a results letter. You will be advised to book an appointment with your GP to discuss the results. This appointment will take place no longer than 2 weeks after you contact your GP. During the appointment, your GP will talk through your risk with you and what you can do about it. If suitable, you will be offered a referral to a genetics specialist for a follow up.
Questionnaires
Everyone fills in a questionnaire after their risk assessment at:
- 1 month
- 3 months
- 6 months
It will ask about:
- your general health and wellbeing
- how you found the testing experience
- your thoughts about breast cancer and risk
Interviews
The team will ask some women to take part in an interview. This is to find out more about what you think about the CanRisk assessment.
They will arrange the interview at a time that suits you. The conversation can be online, in person at your home or at the University of Cambridge. The interview will take about an hour. The team will ask to audio record the interview.
You don’t have to take part in the interview. It won’t affect you taking part in the rest of the study.
Recording GP consultations
If you are asked to see your GP, the study team might ask to video or audio record your appointment. If your appointment is recorded, you will be asked again at the end of the consultation if you are still happy for the recording to be used as part of the research. You can say no at that point and they will delete the recording. Immediately after the appointment, you may be asked to complete a short survey to find out about your experiences of the consultation.
You can say no to having your consultation recorded and to doing the short survey. It won’t affect you taking part in the rest of the study.
Hospital visits
You may be referred to a specialist doctor or nurse at the hospital if you have an increased risk of breast cancer. Your GP will tell you more about this.
Side effects
You will get an estimate of your future risk of developing breast cancer if you take part in this research. Learning about this risk could make you feel anxious. The team will provide you with information about local services and websites where you can find further information and support.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Juliet Usher-Smith
Supported by
Cancer Research UK
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
