What will happen to me if I agree to take part?
If you agree to take part in the study, you will undergo standard mammography or tomosynthesis screening, according to the study randomisation process.
The tomosynthesis imaging is done at the same time as the standard mammogram. The radiographer will take two x-rays of each breast; one from the side and one from above. The breast remains compressed for approximately 8 more seconds for each view. The mammogram images will be viewed by two film readers who have undergone specialist training in the interpretation of both standard screening and tomosynthesis mammograms. You will be sent a letter informing you of the outcome of your mammography screening within three weeks of your visit.
The National Cancer Registration and Analysis Service (NCRAS) collects information on all patients with cancer in England (http://www.ncras.nhs.uk/). This data is linked to routine hospital records (Hospital Episode Statistics). The Office for Data Release, a part of Public Health England, is responsible for the secure sharing of this data. We would like to ask for your permission to access any data that might be held about you, if you do develop any cancers in the future, by the NCRAS, including your hospital records. We will use this data to help ensure we record any breast cancers diagnosed from women participating in this research study. It will also allow us to estimate the cost of any treatment you might receive on your breasts. To do this, we need your permission to use your name, DOB and NHS number to access this data. This information will be transferred securely from the trial screening centre to the Office for Data Release. They will use it to identify any matching records and return them to us after removing any identifying data.
Data from the NCRAS will be stored on a secure server at the Royal Surrey County Hospital and will be held and used in keeping with the Data Protection Act, 1998. The data will not be shared with any other parties. You are free to participate in the trial without consenting for us to access this data and you may also withdraw your consent at any time should you no longer wish us to access this data.
Prospects trial stages
Step 1
Read the information leaflet.
Step 2
You will receive a phone call to discuss the trial
Step 3
Consent using the e-consenting portal
(Optional stage)
Fill out the questionnaire and bring it with you to your appointment. There will be copies of the questionnaire available at the breast screening site.
Possible disadvantages and risks of taking part in the study
The tomosynthesis examination involves approximately 8 seconds of additional compression for each of the two views taken of each breast. Some women experience mild or moderate discomfort during compression of the breast for a mammogram.
Radiation
X-ray mammography involves the use of a small dose of radiation. Tomosynthesis involves an additional dose of radiation roughly equivalent to that of a standard mammogram. Participation in the study would be equivalent to having two mammograms in a row. This has been considered by our radiation protection advisors and is not considered to be a significant risk to health.
The radiation dose of a mammogram is approximately equivalent to three months of the normal background radiation we are all exposed to. The estimated natural lifetime risk of being diagnosed with breast cancer in the UK is 1 in 7. If you undergo 3D mammography as part of the trial (in addition to your standard mammography) then there is an additional risk of causing breast cancer of 1 in 150,000, which is extremely small compared to the natural risk.
Participation details
If you have received information about the trial in the post, this means you have been invited to participate. You will need to read the information leaflet and you will receive a phone call to answer any questions and to see if you are happy to join the trial. You will then be directed to the online econsent form, or at some centres you will be able to complete the paper consent form. If you have any further questions this website should provide all the information you need to help you make a decision. If you would have any questions that you cannot find the answer for on this website, please call the number on your breast screening appointment letter.
Not all women who are based at these screening centres will be invited to participate. You will only be able to participate if you have received an invitation letter and/or receive a phone call to invite you to participate.
If you are with a breast screening centre that is not one of those listed, unfortunately you will not be able to join the trial.
Giving your consent to this trial will allow us to allocate you to either one of two types of breast imaging. You will not be able to know which technique we will perform. You will not be able to choose which technique you would prefer.
Your results will be sent out to you within 2 weeks no matter which technique we use.
If you choose not to consent to join the trial, we will still perform a standard mammogram when you arrive.
Are you eligible?
In order to be classified as eligible to take part in this trial, you must meet the following requirements:
- Aged between 49-71
- Received an invitation to participate
- Able to provide informed consent
Consent form:
Information sheet:
Questionnaire form: