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Hospital/Institution headed paper

Patient Information Sheet

Version 5, 9th March 2016

Bridging the Age Gap in Breast Cancer:

Improving outcomes for older women.

Page 1 of 9Patient Information Sheet, Version 5 9th March 2016


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. Some women may have choices offered to them about which treatment they prefer.

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 also trying to understand how doctors, nurses and patients discuss treatment options and make decisions about treatment. We hope that the results will help us support doctors, nurses and patients make treatment decisions in the future.



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 and the decisions you may have made about them. 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 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 50 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 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, d, e and f 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, your general health and your treatment decision making when you attend for your follow up visits. These are simple questionnaires which should take no more than 40 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 number of cancer cases 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.

e. You can agree to take part in an interview about the discussions you had with your doctors and nurses about your breast cancer treatment and treatment decision making. We only plan to interview a small number of patients, so we may or may not contact you about this. If we do choose to interview you, a researcher will contact you to arrange a time and place convenient to you (this could be your home, the hospital, or somewhere else) for the interview to take place. The interview will take about an hour and will be audio recorded. The recording will then be transcribed and stored securely.

f. You can agree for your consultations with your doctors and nurses that discuss your treatment options to be audio recorded. We only plan to record consultations with a small number of patients, so we may or may not ask you about this before your consultation. The recordings will be transcribed and stored securely.

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 or to take part in an interview 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.

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 Centres at the University of Sheffield and Cardiff. 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 Doncaster and Bassetlaw 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. There is a tick box on the consent form that allows you to say you would like to hear about the results in the future.

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 dignity. This study has been reviewed and given a favourable opinion by the London South East Research Ethics Committee. The study’s Patient and Lay Advocate team have reviewed and advised on the study documents extensively.

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), EU36, Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield S10 2RX. Telephone 0114 271 3611.

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 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 Patient Advice & Liaison Service, Doncaster Royal Infirmary, Armthorpe Road, Doncaster, DN2 5LT. Telephone: 01302 553140.

13. Who is organising the study?


http://www.cancerhelp.org.uk/


The study is being conducted by a research team based at Sheffield University, Sheffield Hallam University and Cardiff University and is being run at over 50 other Breast Units across the UK. The study is being sponsored by Doncaster and Bassetlaw Hospitals NHS Foundation Trust.

The study is being funded by the UK Government through the National Institute for Health Research, the main research funding body of the UK Government.

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), EU36, Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield S10 2RX. Telephone 0114 271 3611.

Please keep this information leaflet for future reference.

Thank you for reading this, and for taking an interest in this research study.


Documents

P - A world-class university – a unique student experience .../file/... · Web viewPage 1 of 9 Patient Information Sheet, Version 59th March 2016 P atient Information Sheet Version