Participant Information Sheet

Study Title: The Experience and Decision-Making Process of Women with Low to Medium Risk of Contralateral Breast Cancer who Have Chosen to Undergo a Contralateral Prophylactic Mastectomy (CPM).

My name is Fehmida Patel and I am training as a Clinical Psychologist on the doctorate course at Lancaster University. I would like to invite you to take part in a study which I am undertaking as part of my training. If you think this is something you would be interested in, please take time to read the information sheet below which may help you decide whether you would like to take part.

What is the purpose of the study?

The purpose of this study is to understand the experience and decision-making process of women within the low to medium risk group of contralateral cancer who have chosen to undergo a Contralateral Prophylactic Mastectomy (CPM). The study is also interested in understanding the psychological effects of the procedure and how it has affected your quality of life. Exploring these issues will allow better understanding regarding how to support and advise other women contemplating CPM as there is currently limited information within this area. Moreover, the information can also aid understanding of how psychological services can improve to better support women contemplating CPM.

Why have I been invited to participate?

You have shown interest in participating in the study as you have undergone CPM.

Do I have to take part?

You do not have to take part and if after reading this information sheet you decide not to take part, then this is fine also. However, if you think you would like to take part you can contact me again and we can then discuss any further questions you may have and you can either decide to volunteer or decline to take part in the study.

If too many people volunteer I will contact you to thank you for your interest and advise that I will not be asking you for an interview on this occasion.

What will I have to do if I agree to take part?

You will have to be interviewed by the researcher about your experience. The interview is expected to last approximately one hour and fifteen minutes and will be recorded. If during the interview there is potential to going over an hour and fifteen minutes, I will stop the interview and ask if you are happy to continue, or, if you would like another appointment to conclude the interview. If you do not want to continue and do not wish to make another appointment, I will stop the interview and use the data collected from the incomplete interview.

As the interview will be recorded, you may ask for the tape to be stopped, edited, or re-played at any point in the interview. We can stop the interview at any point, or, you can decide not to answer any particular questions.

Where and when will the interview take place?

Once I receive an email from you, we can either discuss the details of the study via email, or, you can provide your telephone number and I can contact you. If you are happy to participate in the study we can arrange a suitable time and place to conduct the interview at your home. A suitable quiet room is required as the interview will be recorded using an audio digital recorder. Prior to the interview commencing, you will be given a consent form to read and then we will discuss your experience of undergoing CPM.

However, if you prefer we can also conduct the interview via telephone and this can also be recorded. I would conduct the interview in a quiet room with no one else present to ensure your confidentiality.

What will happen when the interview ends?

After the interview, I will listen to the recording and type out our discussions. I will then attempt to identify themes from our discussion and cross-reference these themes with discussions with other women who have undergone CPM.

The overall data produced by the study will be reported after July 2015. Only summary information and not individual data will be reported, so no individual will be identifiable in the report. However, I may use anonymised direct quotes, with your permission, in writing up the findings. It is possible that some of this data will be published as well as being shared within the research community through conferences and presentations. A summary of the findings will be made available if you request it after this date. The identity of anyone who takes part in the study will not be disclosed at anytime.

Will my participation in this study be kept confidential?

All information collected will be kept strictly confidential. However, if during the interview any information regarding risk to yourself or others is disclosed, this information will be discussed with my academic and field supervisors (Dr. Craig Murray and Dr. Ailyn Garley respectively). However, this will be discussed with you in the first instance wherever possible.

The interview transcripts will be password protected on the computer and will not contain your name (or any names you may mention within the interview) or other identifying information such as your address. Your name and any other identifying information will not be used in any reports and will be kept confidential. Pseudonyms (replacement names) will be used instead. The audio data will be destroyed and transcripts will be stored for 10 years on the Lancaster University electronic database which is password protected and encrypted. After 10 years the transcripts will be destroyed as NHS policy requires for this type of project.

Can I withdraw after taking part?

If you participate in this study you will be able to withdraw your data from the study for up to two weeks after the interview. A request to withdraw after this point may not be possible as the data collected may have already been analysed and themes elicited. It would therefore be difficult to separate individual data and themes from the overall pool collected.

If I have questions who can I talk to?

If you would like to ask questions about this research you can contact the researcher via the contact details below.

What are the risks and benefits of taking part?

There are no direct benefits of taking part in this study. However, some participants find it helpful to discuss their experiences and views after undergoing CPM. It is hoped that the research will help highlight the information required to better support other women contemplating CPM.

It is possible that talking about your experiences about CPM and the impact it has had on your life may cause distress. If this happens during the interview, we can discontinue, or take a break. You are also welcome to contact me after the interview if you continue to feel distressed and I will direct you to further support. This can include contacting the field supervisor, Dr Ailyn Garley (clinical psychologist) on 01282 803049 to discuss the impact of the interview. You can also telephone my academic supervisor Dr Craig Murray on 01524 592730. Some other sources of support are given at the end of this information sheet.

Ethical approval

This study has been granted ethical approval by the National Research Ethics Service (NRES Committee North West-Preston).

Complaints

If you are in anyway dissatisfied with how this research is conducted, complaints can be addressed to the research director: Dr Jane Simpson, Lancaster University Doctorate in Clinical Psychology, Lancaster University, Lancaster, LA1 4YG, Tel: 01524 592858, email: j.simpson2@lancaster.ac.uk. You may also contact my academic supervisor: Dr Craig Murray, Furness College, Lancaster University, Lancaster, LA1 4YG, email: c.murray@lancaster.ac.uk.

Contact Details

This research is carried out by Fehmida Patel, Trainee Clinical Psychologist, Clinical Psychology, Furness College, Bailrigg, Lancaster, LA1 4YG, email: f.patel@lancaster.ac.uk.

The results

You are very welcome to have a copy of the summary of the results after July 2015 if you indicate this is what you would like.

Sources of information and support

Breast Cancer Care
0808 800 6000
www.breastcancercare.org

Macmillan Cancer Support
0808 808 0000
www.macmillan.org.uk

The Haven
0113 284 7829
www.thehaven.org.uk