Hospital/Institution headed paper
Patient Information Sheet Version 3.0
5th August 2013
Bridging the Age Gap in
Breast Cancer:
Improving outcomes for older women.
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Bridging the Age Gap in Breast Cancer: Improving outcomes for
older women.
1. Invitation to participate in the study
We would like to invite you to take part in a research study. Before you decide
you need to understand why the research is being done and what it would
involve for you. Please take time to read the following information carefully.
Ask us if there is anything that is not clear or if you would like more
information. Take time to decide whether or not you wish to take part.
2. What is the purpose of the study?
Breast cancer is a very common problem in older women and over one third of
all cases are seen in women over the age of 70 years. In most the disease is
very effectively treated with a range of treatments. These may include
surgery, hormone blocking tablets, radiotherapy and sometimes
chemotherapy. Every woman and every cancer is different and so some
women have different treatments: some may be offered just hormone
blocking tablets whilst others may be offered more complex treatments
including surgery and chemotherapy.
A great deal of scientific research has been done to ensure that every woman
with breast cancer gets the best treatment for her cancer. However, much of
this research has been carried out on women under the age of 70. This means
breast cancer specialists have much less scientific evidence to guide the
treatment of women over 70.
This study is trying to address this problem and gather detailed information
about how older women with breast cancer are treated and how well they do.
The study is very simple. We just want to follow you through your cancer
treatment, collecting information about how you were treated, how well the
treatment worked and what you thought about the treatments. This will not
change your planned care. If you are happy to do so, we would also like you to
complete some questionnaires for us when you visit hospital (but this is
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optional, you can choose not to do this).
3. Why have I been chosen?
We are inviting older patients (over age 70) who have recently been diagnosed
with breast cancer to take part in this study. The study will be carried out in
many hospitals across the United Kingdom.
4. Do I have to take part?
No. It is up to you to decide whether or not to take part. If you decide to take
part, you will be asked to keep this information sheet and to sign a consent
form. If you later decide not to take part, you can withdraw from the study at
any time. If you withdraw from the study, you don’t need to give a reason and
your care will not be affected in any way.
5. What will happen to me if I take part?
If you are interested in taking part in this study you will have a short
appointment with your doctor or a research nurse. They will go through the
details of the project and answer any questions you may have.
You will then be able to have some time to think about the study and whether
you wish to take part or not: this may take just a short time and you can decide
on the same trip to hospital or you may take this information sheet home with
you to read and decide later. A research nurse will ask you if you wish to take
part or not. If you do not, no one will try to persuade you to join the study and
you do not have to give a reason for not wanting to take part. If you agree to
take part in the study, the research nurse will answer any questions you may
have and if you are still happy to take part, they will ask you to sign a consent
form to take part in the study. This may either be at this hospital visit or at a
time when you would normally be coming to hospital for a routine visit
anyway.
After you have given your consent to take part in the study, the treatment you
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have decided to have will just proceed as normal, with no change.
You can decide how actively you would like to take part in the study. There are
several ways you can take part. We want everyone who takes part in the study
to get involved in Part (a). But you can also take part in parts b, c and d as well
if you wish. These other parts of the study are optional.
The parts of the study are:
a. You can just attend for your follow up visits as normal. We will simply
record information about how you are doing and what treatment you
are having when you attend.
b. You can agree to answer some questionnaires about how you are feeling
and your general health when you attend for your follow up visits.
These are simple questionnaires which should take no more than 20
minutes to complete. We can show these to you before you decide, so
you can see what sort of questions they are. You can take some of
these home with you to complete when it is convenient for you and
simply post them back to us if you prefer.
c. You can agree to let the study team have access to any biopsy samples
of your breast cancer that may have been taken already as part of your
normal care. We won’t do any additional biopsies for the study. We
may ask the laboratory for these samples in the future, to look in detail
at the characteristics of your breast cancer. We hope this will enable us
to develop better tests for predicting which treatments work best for
different patients and lead to advances in the future for women with
breast cancer. It is likely that this part of the study will take a long time,
so while they are likely to help future patients, they are unlikely to
specifically help you.
d. You can agree to let us follow your long-term progress, even after your
clinic has discharged you. This is done by giving us permission to access
your details on the UK National Cancer Registry, where the details of all
cancer patients are kept by the UK Government so they can monitor the
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number of cancer cases and types each year. We will also request
access to the government held registry of all hospital visits, called the
Hospital Episode Statistics data related to you so we can get a better
idea about whether you have suffered from any health problems before,
during or after your cancer treatment.
You will be seen in the clinic 6 weeks after you started treatment and then
every 6 months after you entered the study for 2 years. At all of these visits
your doctor will perform a routine physical examination to check that you are
well and ask if you have had any treatment-related problems. At some visits
your doctor or nurse may also ask you to complete some questionnaires about
your quality of life if you have agreed to do so (these are optional).
6. What are the possible risks and disadvantages of taking part?
There are no specific risks associated with taking part in this study, but you
may suffer some inconvenience in terms of the time taken to fill in the
questionnaires if you have agreed to do these. Your treatment will be the
same as it would have been if you were not in the study.
7. What are the possible benefits of taking part?
This research study will not directly benefit you, but what you tell us will give
us a much better understanding of the best ways to treat breast cancer in
older women and also help doctors and older women themselves to make
better choices about treatment.
8. Will my taking part in the study be kept confidential?
Yes. All information that is collected about you during the course of the
research will be kept strictly confidential. We will contact your GP and let
him/her know that you have agreed to take part in this study if you consent to
let us do so.
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Information collected about you during the course of the study will be securely
stored at the Study Centre at the University of Sheffield on paper and
electronically, under the provisions of the 1998 Data Protection Act.
If you agree to take part in the study, a copy of your signed consent form will
be sent to the Study Centre at the University of Sheffield. Your name will not
be passed to anyone else outside the research team who is not involved in the
study. Any information that leaves the hospital to be passed to the Study
Centre will have your name removed so that you cannot be recognised from it.
You will be allocated a study number, which will be used as a code to identify
you on all study forms. Only the Study Centre and your hospital will be able to
identify you from this number.
With your permission, your relevant medical records may be inspected by
authorised individuals from your hospital, the Study Centre or the University of
Sheffield or the Sheffield Teaching Hospitals NHS Foundation Trust (the study
sponsors). They may also be looked at by the regulatory authorities. The
purpose of this is to check that the study is being carried out correctly.
In line with Good Clinical Practice guidelines, at the end of the study, your data
will be securely stored for a minimum of 15 years. Arrangements for
confidential destruction will then be made. If you withdraw consent for your
data to be used and ask that all records held for the study are destroyed, they
will be confidentially destroyed.
9. What will happen to the results of the research study?
The results of the study will be presented at conferences and published in
scientific journals, and will be made available to you if you wish. You will not be
identifiable in any of the presented or published reports. If you wish, we can
send you a copy of the final report of the study (in about 5 years’ time). Please
let the research team know if this is something you would like us to do.
10.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a
Research Ethics Committee to protect your safety, rights, well-being and
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dignity. This study has been reviewed and given a favourable opinion by the
London South East Research Ethics Committee.
11. What will happen if I don’t want to carry on with the study?
You are free to withdraw at any time and don’t need to give a reason. You can
withdraw your full consent or withdraw from one or more aspects of the study.
For example, you may decide to stop the questionnaires at study visits,
withdraw permission for us to access your previous tissue samples or withdraw
permission for us to access your information held at the cancer registry.
If you withdraw your full consent we will use your data up to the date on which
you withdraw consent. We would not collect any information about you after
this date. We can also destroy all your data should you want us to.
If you do not attend study visits (for example, you may move away) and have
not withdrawn your consent, your data may be tracked through the Office of
National Statistics (ONS) and the NHS Central Register (NHSCR). To be able to
do this, and only with your permission, authorised individuals from the Study
Team may request your details from your doctor (which will include your full
name, date of birth, NHS number and last known address) and send these to
the NHSCR so that we will be able to find out how you are doing.
12. What if I am unhappy about any aspect of the study?
If you have any concerns or complaints about any aspect of the study please
contact in the first instance the Chief Investigator on the study:
Miss Lynda Wyld (Senior Lecturer and Consultant Breast Surgeon), E Floor,
Royal Hallamshire Hospital, Sheffield S10 2JF. Telephone 0114 271 2510.
You may also find it helpful to contact Macmillan Cancer Support, an
independent cancer information charity (freephone: 0808 808 00 00 ; address:
Macmillan Cancer Support 89 Albert Embankment, London, SE1 7UQ 3 Bath
Place, Rivington Street, London, EC2A 3DR; website
http://www.macmillan.org.uk) or CancerHelp UK, an information service about
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cancer and cancer care for people with cancer and their families provided by
Cancer Research UK (Tel: 020 7061 8355; website www.cancerhelp.org.uk)
If you remain unhappy and wish to complain formally, you can go through the
NHS Complaints Procedure by contacting The Medical Director, Sheffield
Teaching Hospitals NHS Foundation Trust, 8 Beech Hill Road, Sheffield, S10
2SB. Telephone: 0114 271 2178
13. Who is organising the study?
The study is being conducted by a research team based at Sheffield University,
Sheffield Hallam University, the Sheffield Teaching Hospitals NHS Foundation
Trust and over 20 other institutions across the UK. The study is being
sponsored by Sheffield Teaching Hospitals NHS Foundation Trust.
The study is being funded by the UK Government through the National
Institute for Health Research.
Contact for further information
If you want any further information, or have any questions concerning this
study, please contact the Chief Investigator, Miss Lynda Wyld (Senior Lecturer
and Consultant Breast Surgeon), E Floor, Royal Hallamshire Hospital, Sheffield
S10 2JF. Telephone 0114 271 25 10
Please keep this information leaflet for future reference.
Thank you for reading this, and for taking an interest in this research study.
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