Age Gap Supplemental Protocol
Relative, Carer or Friend Patient Information Sheet,
Process Evaluation,Version 3, 95thOctober March 20165
Bridging the Age Gap in Breast Cancer:
Improving outcomes for older women.
Bridging the Age Gap in Breast Cancer:
Improving outcomes for older women.
Participant Information Sheet for Relative/Carer/Friend for the evaluation of counselling and treatment decision making support
Invitation
We’d like to invite you to take part in a part of the Bridging the Age Gap in Breast Cancer study which is evaluating support for treatment decisions in older women with breast cancer. Before you decide if you want to take part, you need to understand why the study is being done and what it will involve. 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.
What is the study about?
For some women with breast cancer there are several different treatment options. The decision about what treatment to have can be complex, with pros and cons for each option. This study aims to understand how doctors, nurses and patients discuss treatment options and make decisions about treatment. This includes discussions which involve a relative, friend or carer who is making the treatment decision because the patient is unable to decide for herself what treatment to have (as a result of loss of intellectual capacity). The results will help us support doctors, nurses and patients (and their carers) to make treatment decisions in the future.
Why have I been chosen?
We are inviting a small number of relatives, friends or carers who have made a decision about breast cancer treatment on behalf of their relative or friend because she is no longer able to decide for herself due to a loss of intellectual capacity (memory loss/dementia).
Do I have to take part?
No, taking part is entirely voluntary. It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you later decide not to take part, you can withdraw at any time. If you withdraw from the study, you do not need to give a reason and your care and the care of your relative/friend will not be affected.
What will happen to me if I take part?
If you decide you would like to take part there are three things that will happen:
1) The consultations to discuss your relative’s/friend’s treatment options may be audio-recorded (this is optional).
2) You will be asked to complete two short questionnaires (one after a consultation about your relative’s/friend’s treatment options and one a few weeks afterwards which will be posted to you).
3) You will be interviewed by a researcher (not your relative’s/friend’s doctors and nurses) about your discussion about the treatment options and the information and support you received at a later date that suits you.
A researcher will contact you to arrange an interview at a time and place convenient to you. The interview could be at the hospital, in your own home or elsewhere if you prefer. If being interviewed meant you had to travel, we would refund your travel costs. The interview will take about an hourand will be audio-recorded. The recording will then be typed up and stored securely.
Are there any risks?
There are no specific risks associated with this study. During the research interview you do not have to talk about any issues you don’t want to discuss. If you find the interview upsetting (which we do not expect) it can be stopped at any time.
What are the possible benefits of taking part?
This research study will not directly benefit you or your relative/friend, but the results should help us to provide better support for people making similar decisions about breast cancer treatment in the future.
What about confidentiality?
All information that is collected about you during the course of the research will be kept strictly confidential. 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 and at Cardiff University, 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 University. Your name will not be passed to anyone else outside the research team who is not involved in the study. Any stored files/interview recordings will be stored with only an identification number, not your name or address. Only the Study Centre (Sheffield University), the research team at Cardiff University and your hospital will be able to identify you from this number.
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.
What will happen to the results of the research study?
The results of the study will be presented at conferences and published in scientific and medical journals. Any quotes from consultations or interviews used within reports or publications will be anonymous. A copy of the research findings will be available to you at the end of the study if you would like it (it may be several years before this is available). Please let the research team if you would like to receive a copy of the findings when you give consent to take part and we will ensure these are sent to you.
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 research has been approved and authorised by the LondonSouth EastResearch Ethics Committee.Our Patient and Lay Advocacy team have extensively reviewed and revised the study and its documents.
What happens if I do not want to continue with the study?
You are free to leave the study at any time. You do not have to give a reason and your care and the care of your relative/friend will not be affected. All of your information will be withdrawn from the study.
What if I am harmed or unhappy about any aspect of the study?
If you have any concerns or complaints about any aspect of the study please contact Ms Lynda Wyld (Senior Lecturer and Consultant Breast Surgeon), E Floor, University of Sheffield Medical School, Sheffield S10 2JF. Telephone: 0114 2713611.
If you remain unhappy and wish to complain formally, you can go through the NHS Complaints Procedure by contacting The Medical Directorthe Patient Advice & Liaison Service, Doncaster Royal InSheffield Teaching Hospitalsfirmary, Armthorpe Road, NHS Foundation Trust, 8 Beech Hill Road, Sheffield, S10 2SB. Doncaster, DN2 5LT. Telephone: 0114 271 217801302 553140.
Who is organising and funding the research?
The study is being run by the University of Sheffield, Sheffield Hallam University, Cardiff University, Sheffield TeachingDoncaster and Bassetlaw Hospitals NHS Foundation Trust and is being conducted in over 50 Breast Units across the UK. The study has been funded by the UK Government’s main research funding body, the National Institute for Health Research (NIHR).
Who do I contact for further information?
If you would like any further information, or have any questions concerning this study, please contact Dr Kate Lifford, Research Associate, Institute of Primary Care and Public Health, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS. Tel: 029 2068 7809. Email: .
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What do I need to do now?
If you would like to take part please complete the consent form and return it to the person who gave it to you.
Feel free to call us with any queries you may have and/or talk the study over with anyone else.
Please keep this information leaflet for future reference.
Thank you for reading this information sheet and for taking an interest in the research study.
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Carer Information Sheet – Process Evaluation, Version 32 95thOctober March 20156