TO BE PRINTED ON HOSPITAL HEADED PAPER
PATIENT INFORMATION SHEET
Mammo-50: mammographic surveillance in breast cancer patients aged 50
years and over
We would like to invite you to take part in a research study called Mammo-50.This
information sheet explains why the research is being done and what it will mean for you.
Please take time to read it carefully and discuss it with friends, your family and your GP, if you
wish.
Part 1 explains what will happen if you take part.
Part 2 gives you further information about the study.
A member of the research team will go through this with you. Please ask if there is anything
that is not clear or you would like more information. Please take as much time as you need to
decide whether or not you wish to take part.
Your participation in this research is entirely voluntary. If you decide not to take part, you will
receive usual, standard treatment and your medical care will not be affected in any way.
Part 1
What is the purpose of the study?
You received surgery for breast cancer approximately 3 years ago. Since then you will have
seen your doctor or nurse at intervals to check that you have been well. You may have also
had mammograms to try and check that the cancer has not returned. This is known as
mammographic surveillance.
However, we do not know the best approach to follow-up women aged 50 years and over and
practices vary across the UK. There is no clear evidence on how often mammograms should
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be carried out and for how long after surgery. Current methods of follow-up care can be
stressful for patients, costly for the health service and time-consuming for both. These
services were established when scans were less sophisticated and less women survived breast
cancer. Research indicates that women aged 50 years and over may need less frequent
mammograms if they are supported and monitored in other ways such as follow-up
programmes through GP surgeries or Hospital Out-Patient Clinics
The purpose of the Mammo-50 study is to investigate the most effective and safest way of
monitoring women of 50 years or over who have had breast cancer surgery. It will also
consider acceptability to patients and value for money. It will eventually inform national
guidelines about the best way to follow up women who have had surgery for breast cancer.
What is being tested?
We are testing the optimal frequency of mammograms after breast cancer surgery for women
who are aged 50 years and over. This is to ensure that women receive enough mammograms
to detect any cancer recurrences promptly and to offer further treatment appropriately, but
not so many that they cause undue anxiety and become too costly for both individuals and
the health service. We also want to find out about other methods of follow up which take
place such as clinic visits to see your doctor, visits to see the breast care nurse or telephone
follow up, and how these affect your quality of life.
Why have I been invited?
You have been invited because you are aged 50 or over, you received surgery for breast
cancer approximately 3 years ago and you remain free of cancer. We do not know the best
way to follow-up women who are your age and who have had your type of breast cancer. We
will be recruiting 5000 women over about four years from approximately 100 UK cancer
centres and hospitals.
Do I have to take part?
No. It is entirely up to you to decide whether or not to take part and your care will not be
affected in any way if you do not enter the study. If you do, you will be asked to sign a Consent
Form. If you change your mind, you can withdraw at any time, without giving a reason. This
Information Sheet is yours to keep whatever you decide.
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If you do not want to take part in the study it would be very helpful if you would allow us to
follow you up, during your standard breast cancer follow up and/or mammography. This can
be done via bodies such as Public Health England and the Office for National Statistics and will
not require any action from you. Please let your doctor know if you do not want to take part
in Mammo-50 but are happy to be followed in this way. We will ask you to sign a different
consent form.
What will happen to me if I take part?
All women who take part in Mammo-50 will be allocated to one of two types of
mammographic surveillance using a process called randomisation. Randomisation is a
process in which a computer is used to allocate which group you will be in and it means you
have an equal chance of being in either group. This is to ensure an equal distribution of patient
characteristics in both groups. Neither you nor your doctor can choose which group you will
be in.
Group 1: If you are in group 1 you will have a mammogram once a year for another six years.
You may also see your doctor or nurse depending on your hospital’s policy.
Group 2: If you are in group 2 you will have less frequent mammograms. If you had a full a
mastectomy, you will have three-yearly mammograms for another six years (i.e. two more).
If you have had ‘breast conserving’ surgery (also known as a wide local excision), you will have
two-yearly mammograms for another six years (i.e. three more). You may also see your doctor
or nurse depending on your hospital policy.
For both groups: You will be asked to complete a questionnaire booklet which is designed to
measure your general and post-treatment health. You will be required to complete a
questionnaire booklet before randomisation and at the time of your surveillance
mammograms. If you take part in the trial you will not be taken out of the national breast
screening programme and will continue to receive a letter of invitation every three years.
However, we would ask that you do not attend these screening mammograms whilst you are
receiving mammograms as part of Mammo-50(Please ring the breast screening office number
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on the invitation letter to cancel the appointment if you receive one). This is to avoid
duplication which may affect the results of the study.
If you have any concerns please discuss this with your research team
Optional for both groups: There are also three optional sub-studies that form part of
Mammo-50. By taking part in these, you will be helping to build a complete picture of the
surveillance mammography and breast cancer follow-up that is taking place in the UK today.
This will help health policy makers to formulate recommendations for best practice in future.
However, you may take part in the main study without consenting to take part in one, two or
all of these. There will be an option to sign up for these or not on the consent form. The
optional sub-studies are:

Optional Quality of Life Study: This will help to assess how women who are receiving
surveillance mammography and breast cancer follow-up feel in terms overall
wellbeing and concern over any long term symptom and side-effects associated with
cancer treatment. If you take part in this you will be asked to complete an additional
questionnaire booklet which will be sent to you or given to you by a member of your
hospital team if you are receiving breast cancer follow-up.

Optional Qualitative Research Study: We will be interviewing a number of women who
have had breast cancer to gain information about their experience and perspectives
on receiving surveillance mammography and breast cancer follow-up. This will help us
to find out what needs you may have and how we can best deliver services in future.
The interviews will take place as part of a focus group or as a one-to-one interview
with a researcher. If you decide to take part in Mammo-50, you will also be asked if
you consent to attend a focus group or be invited to be interviewed in the future. This
will not commit you to taking part and you may change your mind later. If you are
invited at a later date you will be asked to read an additional patient information sheet
and sign a consent form for participation in the interview/focus group which, with
your permission, will be recorded.

Optional Tissue Study: We will be requesting some tissue samples from women’s
breast cancer surgery in order to assess the characteristics of their cancer. If you agree
to donate any surgical samples, these will be a gift for future research. You will not
have access to individual information generated from these samples.
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What are the alternatives for follow-up?
If you do not wish to take part in Mammo-50 you will receive the standard breast cancer
follow-up for your hospital. This varies from hospital to hospital.
What are the other possible disadvantages and risks of taking part?
We still don’t know the best and most effective way of monitoring patients after they have
had surgery for their breast cancer. However, we do know that some women find regular
visits to the hospital cause anxiety where as others may feel anxious if they receive less follow
up visits to the hospital. By taking part in the study, you may receive more mammograms than
you would normally at your hospital or you may receive less. If you have more mammograms
than normal then the chance of getting a new cancer through receiving additional radiation
is 1 in 6300; therefore the risk from any additional exposure is considered to be low.
Women who take part will also be asked to complete questionnaires. These will take
approximately 15-30 minutes to complete and will be done every time you attend for a studybased mammogram, which may be an inconvenience.
What are the possible benefits of taking part?
There are no known benefits in taking part in Mammo-50 for you. However, depending on
how you are affected by the number of visits to the hospital whether it is for a clinical follow
up or a mammogram, you may find that if you receive less or more you will be less anxious.
The information gained from this study should help improve follow-up after breast cancer
surgery for women in the future.
What happens when the research study stops?
After you have your last study-based mammogram you should attend for mammograms
offered as part of the breast screening programme. It will be made clear to you when your
participation in the trial has finished. However, if you are at all unsure you should contact the
research team at your hospital. We will continue to collect available information on your
health for several years via agencies such as the Office for National Statistics and Public Health
England.
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It is very unlikely that the study will end before your follow-up is complete. However, if this
happens, you will be offered the standard follow-up for your hospital and your progress will
be followed in the same way.
What if there is a problem?
If you have any problems or queries while taking part in the trial, let your research nurse
know and they will be asked to refer you via your GP to rapid access to your hospital
specialist if needed. More information will be given to you in Part 2 of this information
sheet.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled
in confidence. There are more details about this in Part 2.
This completes Part 1 of the Information Sheet.
If you think you might join the study, please read Part 2 before making your decision.
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Part 2
What if relevant new information becomes available?
We may obtain new information from other research that is important for Mammo50 and we might want to change the study as a result. If this happens, your doctor will
discuss this with you and you will decide whether or not to continue in the study. If
you decide not to continue, your doctor will arrange for your future care. If you do
continue, you may be asked to read a new Information Sheet. You might also be asked
to sign a new Consent Form.
What will happen if I don’t want to continue with the study?
You can withdraw from the study at any time and without giving a reason. Information
already collected may still be used unless you request that it is not. We will discuss
your further treatment and follow-up and your decision to withdraw will not affect
your future care.
What if there is a problem?
If you wish to complain or have any concerns about the way you have been
approached or treated by members of staff during your participation in the research
the National Health Service complaints mechanisms are available to you. Please ask
your research doctor if you would like more information on this.
In the unlikely event that you are harmed by taking part in this study, compensation
may be available. If you suspect that the harm is a result of the sponsor (University of
Warwick) you may be able to claim compensation. Please discuss with your doctor,
then make the claim in writing to [insert name]Janet Dunn, Warwick Clinical Trials
Unit, University of Warwick, Coventry CV4 7AL. This will be passed to the university
insurers. You may have to bear the costs of the legal action initially and you should
consult a lawyer about this.
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Will my taking part in this study be kept confidential?
All personal information collected for Mammo-50 is strictly confidential and is covered
under the Data Protection Act 1998. Information about you will be held on a secure
database at the Mammo-50 Trial Office at Warwick Clinical Trials Unit, University of
Warwick. Only authorised personnel at the Trial Office can access this.
With your permission, we would like the Mammo-50 Trial Office to hold a record of
your personal details. This includes your NHS/CHI number, date of birth, name and
address. We may use this to send you questionnaires and other information by post.
We would also like to contact the Health and Social Care Information Centre and the
Office of National Statistics about you as they collect long-term information about all
NHS patients. However, when you join Mammo-50you will be given a unique study
number and we will use this and your initials only in any communication about you.
We will not use your name.
Your doctor will usually inform other doctors and nurses who look after you that you
are in Mammo-50. This includes your GP. You must inform your doctor if you do not
wish for this to happen.
If you choose to withdraw from the study we would still like to collect information
about you. This will be useful to our research. If you have any objection to this please
let your doctor know if you do decide to leave the study.
What will happen to the results of the research study?
The results will be published in scientific journal after a number of years and presented
at professional and academic conferences. If you wish, we will send you a report of
the results of the study. You will never be identified in person in any report about the
study or in the study results.
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Who is organising and funding the research?
The Warwick Clinical Trials Unit at the University of Warwick is organising the study
and the National Institute of Health Research Health Technology Assessment
Programme is funding it.
Who has reviewed the study?
The study has been approved by the Department of Health’s National Institute for
Health Research and a UK National Research Ethics Committee. It has also been
approved by patient and carer representatives.
What to do if you wish to take part in the study?
If you wish to join this study you will be asked to sign a Consent Form. There will be
further discussion with the researcher before you sign it. You will also be given a copy
of this Information Sheet and your signed Consent Form. Your GP will be sent a letter
telling them about Mammo-50 and that you are taking part.
If you decide not to take part, your care will not be affected in any way, and there may
be opportunities for your experiences of breast cancer care to be used for benefit for
future care of other patients. Please feel free to discuss this with your specialist or
research nurse.
Thank you for taking time to read this information sheet.
If you would like any independent information about taking part in research, you
may find it useful to contact one of the following organisations:




Macmillan Cancer Support: 0808 808 0000 (Free phone)
http://www.macmillan.org.uk
Breast Cancer Care: Tel: 0808 800 6000 (Free phone)
http://www.breastcancercare.org.uk
Cancer Research UK Tel: 0808 800 4040 (Free phone)
http://www.cancerhelp.org.uk
PALS (Patient Advice and Liaison Service)
Ask your GP or Phone NHS 111 for details of your nearest PALS
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