Aileen

Age at interview: 57

Age at diagnosis: 56

Brief Outline:

Aileen was diagnosed with breast cancer in December 2016 and she underwent surgery followed by a six-treatment course of chemotherapy.

Background:

Aileen is married with two adult daughters. She is a registered nurse and a teacher. She is white British.

More about me...

Aileen was diagnosed with breast cancer in December 2016 and she underwent a lumpectomy with a sentinel node biopsy procedure which led to a further excision and a complete armpit clearance of her lymph nodes. Next, she started a six-treatment course of chemotherapy and at the time of the interview she had one more cycle to complete. She was due to have 20 sessions radiotherapy. 

Aileen’s involvement with the 100,000 Genome Project started when she met her breast surgeon to talk about her first operation. At this stage she was given the Information Pack to take home to read. She found it very useful to be able to read the information at her own leisure to make sure she understood what the project would involve before committing herself to it. But, describes the information leaflet as “very wordy”.

During her pre-op assessment, Aileen and her husband also met a research nurse who provided further information before Aileen consented to take part in the project. The nurse went through the consent form in detail and was happy to answer questions. Aileen has two daughters and was interested to find out if the information about her genetic profile would be of benefit to them. She liked the fact that the consent form has separate boxes, each of which has to be initialled and ticked - each containing different instructions, rather than just providing a general signature for everything. At the end of the meeting, she was given a photocopy of her consent form and she also knows that she can change the instructions she consented to if she wishes to do so.

On reflection, the information and invitation to take part in the Genome project happened at a time when lots of other things were going on in Aileen’s life like the impact of diagnosis, treatment plans, appointments and so forth. So at times, she found it all too much. Despite this, after reading the information and understanding the extent of her participation she realised that she didn’t have to do much - apart from giving tissue and blood samples. She saw only benefits and that’s why she decided to signed the consent form. Her only concern was that she doesn’t know which health professional will get her results, whether it will be her GP or consultant.

Aileen feels that Genomic England should update the information leaflet and also publicise their website address more broadly. Aileen didn’t know about the GEN site when she was diagnosed and felt she missed out on another source of information that was easily available. Another request she made to Genomic England was to send a reminder to participants that they are still part of an ongoing project.

Aileen has no concerns about data protection because she knows her samples were anonymised. Besides, she says that medical research has to go through so many “ethical hoops” to get approval that it is one of the safest ways to have personal information “out there”. She thinks that data sharing with companies, like the drug companies are necessary to help develop the treatments that are needed.

Aileen suggests the link to the Genomics England project website could be more prominent in the initial information pack.

And in terms of the information given was it useful? Was something missing? Was there something that needed to be improved?

Well the fact that I didn’t realise about the Genome Website [ha]. It’s about something that, you know, as I say I do go on things and I do look and I missed that completely. So perhaps some information about go onto these sites that’s maybe in a bit more, bit larger print than. Would be quite useful and given with the initial information. You know, if you’re interested in this project go onto our website that will give you more information because if somebody doesn’t like it in a written format they could look at that before meeting the research nurse. So that would be a really good, you know, maybe not for older people who may not have access but certainly for most people they would go on and have a look online.

Ok. So maybe to give more information about the address; the website.

Yes just on that initial one in the initial papers to say if you are interested there is a website you can look on for more information.

Aileen was reassured that she wouldn’t have to disclose any results from the project to travel insurance companies.

And also another thing I read there and I asked about was my travel insurance and my health insurance and things because you know, you go into a project like this and you might find out things that you didn’t know and then how does it affect the rest of my life. I can’t get travel insurance from now on because I’ve had screening for this disease or that disease. So, you know, that affects, that would have affected me. So that could have been a pitfall [ha]. 

Exactly.

But I was reassured. It states in the information that actually you come to an agreement that it doesn’t affect travel insurance. So that’s actually, you know, part of the consent form. So that was reassuring to me that actually I don’t have to disclose any information.

Aileen was glad her husband was there when she was invited to take part in the project so that she could chat to him about it. She later talked to her grown up children about any risks involved in taking part.

I discussed it with my husband and also my daughters. My daughters are 28 and 30 so adults. And actually, you know, you do think 100,00 people you are one of the chosen ones [laugh]. It’s not available to everybody. So it, you know, it’s something different and so I did discuss it with them and they didn’t have any worries about it either. As I say they look at the risks to me as well. That’s what they would be worried about and there weren’t any.

So

So it’s fine

During her first appointment with her consultant, Aileen was given an information pack to read at home. At her pre-op appointment she had a discussion with the research nurse before she signed the consent form.

My involvement in the Genome Project started when I met my breast surgeon to talk about my first operation. I was given information about two different trials and the Genome Project was one of them. At this stage it was the Information Pack that was given to me so I could take it home and read it at my leisure to make sure I understood before I went any further. And this was slightly different to another trial which gave me more information. However being able to take the Genome Project information home was very comfortable for me because I like to go through things thoroughly so that was a real benefit.

The next I heard about the Genome Project was during my pre-op assessment when I was seen by a research nurse who ensured I’d read the information and then went through things stage by stage making sure when I signed a Consent Form, because I was interested, I knew everything about each specific tick that I made on the consent form.

Questions that I asked about were mainly linked to what would happen with the information that they’d got from me: The blood test results, the biopsy results, my tissues, my blood, but also the information that they could give me that would benefit me in the future and also benefit my family. So looking at what my genetic profile was: Was there anything in that profile that actually I could know about that would help me in the future and as I say also help me family. I have two daughters. These questions were answered in quite a simple way in that I was told that if I ticked the boxes to say that I wanted this information I could always change my mind. If I didn’t want to tick the box equally that was, that was fine. There was no pressure put on me. However what I will say is that it was, the consent and information was given to me at a time when I was taking in a lot of other information about pre-op, about an operation, about my diagnosis. And there were times when I just thought, “Is this too much? Do I want to do it?” However having read the information I realised that actually I didn’t have to do very much at all. It was very much, you know the tissue sample was going to be there anyway. The blood tests I was going to have a pre-op and blood. It was just going to be another vial of blood. And actually there was very little input from me to be involved in this trial. I could only see benefits. And then that’s why really I signed the consent and went with it. 

And do you remember how long more or less that conversation lasted?

I would think it was probably about 20, 25 minutes.

Ok.

But it could have been longer. She wasn’t in any rush. I didn’t feel there was somebody behind me waiting to talk to her. You know there. And it was all very relaxed. My husband came in with me as well and so he was able to ask questions. And I think that’s really important too because, you know, my mind was fixed on other things really whereas he, his head was just fixed on what people were, were telling me at that moment. So it was very useful having him there and the questions about, “Did I want to know about my genetic profile?” It was good to have somebody else to just chat to about that and kind of think, “Do I want to know?” Because initially I thought, “No I don’t. No I won’t want to know.” You know this is happening to me already and I don’t want to know anything else.

Exactly

But equally when you think about it sensibly and having somebody there to say, you know, the benefits about it. Then that made a big difference to me. And I felt better ticking the box to say, “Yes I would like to know.” Because I always have the choice to opt out. 

Aileen liked that there were options on the consent form about how much you could agree to take part in.

Is the kind of the content of the information, the content of the leaflet sufficient or would you have liked more?

Yeah I think so. I liked the fact that I had to initial each part. That was useful because sometimes you sign a consent form and a consent form at the end. And you sign everything, you know with one signature and it did make me read it. And by having to sign to initial each part the tick boxes as well were quite useful because it gave you the options in a kind of staged way. So that it wasn’t just a, you know, you agreed to this. You, you were given options about how much you agreed to. So I, I quite liked that. It’s quite wordy. So again if people find the reading difficult and I presume it’s in different languages as well, you know, it is quite wordy but that’s why the research nurse goes through things. So, verbally both verbally and written. So I didn’t find the information too difficult to deal with. 

Aileen said the process of giving a sample was very easy as blood samples were taken the same time as her pre-op assessment blood tests and a tissue sample was taken during her operation while she was under anaesthetic.

So the tissue that is used. It was very easy. Any donation I had to make of blood tissue was very easy because the tissue was taken during operations when I knew very little about it. And they were taking tissue anyway. As far as I know no additional tissue was taken. It would be, you know, it was what was taken anyway for pathology. So, and I was under anaesthetic so it didn’t affect me. The blood samples I believe I probably had one additional blood sample taken during my pre-op. So whether that was for the Genome Project but I was having blood taken anyway. So the fact was if there was one more phial of blood taken it, again it didn’t affect me. It was taken at a time I was having blood taken anyway. And yes, and since then I’ve had regular blood tests and I presume any further information the Genome Project needed would be taken at the same time. So the fact is I don’t feel as if I’ve had any more tissue or blood taken than I would have had if I hadn’t signed up for the project.

Aileen knows that a research project has to go through a strict research ethics approval procedure so she isn’t worried about her personal data being kept on a database.

Because the consent form contains several tick boxes about the use of health data, confidentiality and so on. Did you understand the sections fully?

Yes I did. I think there was. I mean obviously the university will be using the data but there is also other people. And I am very aware that medical companies need that information if they are producing medication and treatments they will need that information as well. I believe that I am a number. My name isn’t given on anything. So that makes me anonymous.

Ok.

To that type of company. So I will be a number rather than a name. They won’t know where I live or who I am. It’s anonymous (de-identified).

So you understand about that fully. And how did you feel about it? I mean did you have any kind of queries or kind of concerns or.

Well I mean databases are database aren’t they and IT is IT? And you hear about people, you know, being able to access information. I honestly think there is nothing in my information that, you know, that is particularly worrying to me. I wouldn’t want anybody, everybody to have my information but actually, you know, I do have breast cancer. I’ve [laugh]. You know there’s an awful lot of people who know an awful lot about me anyway. You could always live on the what ifs, what ifs and that percentage is very small and the risk is very minimal. And I think the fact that it is research that’s you know, ethically people who do research have to jump through so many hoops to get approval that actually probably it’s one of the safest methods of having your information out there anyway. So it, it doesn’t worry me particularly. I think we’re at risk anyway and it doesn’t put me at any more risk. I don’t think.

Aileen thinks that it’s important for her de-identified information to be shared with commercial companies so that they can develop treatments.

Was anything said about possible commercial uses of the sample just by private companies, drug companies etc. I think you touched on that in the sense of medical research.

Yes.

And…

Yes so that again is included in the consent form. It does, it does state that results of the research will be used commercially. But again that’s what this is all about. And there is no use doing some research in genetics if then the companies that can do something about the treatments don’t get that information. So for me that was part of the process and part of the, part of being involved and the purpose of the study. So I think if you consent to being part of the Genome Project you have to realise that it will be used commercially. Your information will be used but as part of the group and anonymised (de-identified) and one of the 100,000 people rather than who I am, where I am and.

Ok, ok. So did you have any worries about it?

No I didn’t have any worries about how my information would be used.

Or do you have any worries now.

No, no.

Aileen says she is a “rather know about it kind of person”.

I think I’m kind of a, I’d rather know about it kind of person. And I could see the pitfalls for people who may prefer to go through life without really [ha] knowing if they, you know. If something comes back and I need to be screened for something I would rather know now than in ten years’ time. So for me it’s a benefit. I can see pitfalls for people because I, equally some people that would be difficult to cope with. For me, I can’t see any pitfalls. I just see it as, as a benefit.

Benefit ok.

As I say I don’t need to do anything [laugh]. You may want an extra blood sample from me but actually I am giving blood all the time anyway.

Aileen would quite like a reminder that she is in the project because “years go by and I will forget that I’ve signed that consent form”.

I’m not aware of, if I am going to have to give anymore samples in the future. And if I do I assume that it would be if I had to have any more operations or tests and it would be done at the same time as that. You know, would I remember that some of it may be going to the Genome Project. I don’t know And I think maybe that’s quite a useful thing as well is kind of being reminded that you are part of it every now and again. Because it would be very easy to forget that actually you are part of the project and it can, you know, it can carry on after your death. Even the, you know, they may take tissue samples. And so, you know, I’m in my late 50s hoping for another 30 years. And I will have forgotten that I’d signed up for this project. So maybe just a reminder, gentle reminder that you are still part of the project in the future would be quite nice.

So a letter or

Yes

Sent

Yes just to, you know, because years go by and I will forget that I’ve signed that consent form because this part of my life will be over and it’s very much associated with this diagnosis in my own mind when actually it’s an ongoing programme that can affect me for the rest of my life. So, you know, again looking at it and just thinking about it that might be quite nice just to, to have a reminder every now and again that you are still part of that.

Aileen feels it’s important to read all the information and ask questions before deciding to take part in genomic research.

I would just say before you take part in anything read all the information, ask the questions because you have the opportunities to ask those questions during the consent interview. So read the information before you go so you have those questions because you have so many questions in your head when you are first diagnosed with something like cancer that it can be very easily lost. And, you know, you need to go with those questions in your head. Write them down if you want to remember them because when you are sitting with somebody often your head is somewhere else. And you are not concentrating on the one thing that you are doing at that moment. So just write the questions down before you go so you’ve got them and, and tick them off when you’ve asked them. And make sure that you get all the information you want before you sign the consent form because people will take time to speak to you until you are happy that, and they are happy that you understand what you are signing. And I think that’s really important as well. It’s having that trust with that healthcare professional that they will take that time.