What, looking back, would you say were your main reasons for wanting to take part?

Well, the fact that it specialised in something I had, a problem I had, and these were people who were specialising in that subject. So they were – well, I suppose they knew more what they were talking about, to put it, you know, put it bluntly [laugh]. It tended to be they gave you much more time. You went there and they took say nine or ten readings, which gave them a much more accurate reading of your blood pressure. Whereas your GP would only have time for one, usually just one reading, and very often it’s much higher than you’d expect, you know. What tends to happen is the first one’s high, the second one’s slightly lower and then the third and fourth ones are a little bit lower still, and then they, it starts to level off. So it’s a much more accurate way of, you know, finding the reading. And, yeah, I mean it’s so relaxed. You know, you’d there for about an hour, two hours. If you’re giving blood, you had to fast for twelve hours, so you had sort of tea and toast and biscuits and all that afterwards [laugh]. And you just felt you were being well looked after. You know, I wasn’t rushed in and rushed out.

Did, were you at all thinking about the wider importance of research for the rest of society? Or was that not really an issue in your decision?

Well, I suppose I was, but to be honest I think it’s more of a sort of personal thing, you know. I mean, I was glad other people can benefit from what they’ve found out. That’s a general thing. But at the same time it’s helping me. it’s my personal, you know, it’s a problem I had. So I was quite happy to do it. But I suppose, yeah, it, it does, it does make you feel better knowing you’re, you’re helping other people. Yeah.

What happens is that I get, at the beginning I got scanned after every two sets of treatment, and they want to see what’s happening to the cancer cells, basically. So I get scanned from my neck through my abdomen, and then they have a look at the scan result and they see what’s been going on, and now I’m scanned every three treatments.

After my first scan they were really, really thrilled that the tumour had gone down by so much. They said it was not all that usual to have it go down. And the fact that it then stayed as stable as it has done, they’re extremely pleased with what I do, and they really are quite, also, chuffed at the way I try and use my lifestyle.

When we are in our chemo unit having treatments, we do all talk to each other and in fact it’s the one place where you can really, really, really feel safe. You can say, I’m absolutely fed up. it’s just not fair, why have I been landed with this? Oh dear, I’ve got to go and do this, that and the other, and I really don’t feel like i, and you can really unburden yourself both to your fellow sufferers and to the nurses, who are extremely empathetic and sympathetic.

Also the chemo nurses make you want to keep going as well. They get extremely upset if you have a backward step. When they found that the tumour liver had got bigger, they were really desperately upset, and they said, you know, Of all the people, we just really find it quite remarkable that it’s happened to you and we’re so sorry And they’re really just wonderfully, wonderfully sympathetic. And we know all about their holidays and their friends and all sorts of things like that, which is very nice, and the treatment is super and so that’s great as well. Because if you can trust your medical practitioners, that’s what you really, really need. When you go up there and you think, Yes, that’s fine. they’re going to get the cannula in without making me feel like a pin cushion and they’re going to be able to take my blood quite easil, then at least that’s one bit of you that’s quite secure. And that’s what you need. There’s enough other things going on which make you feel insecure, but at least when you get to the hospital and get your treatment, if you’re there and you’re in this cushioned environment, it’s very, very encouraging.

They were very specific saying that, It is a trial. it’s early days. We haven’t got any result, that a lot of the tests that went along through the process of the trial had been changed, and, and a lot of the blood tests were made more regularly, because it had been trialled in the States and they’d had one person die on the trial through kidney failure because they hadn’t been monitored, they hadn’t monitored the effect as much. So I knew that, and they had, they had made more blood tests available so so they could, they did monitor you very, very carefully, and have been, in all the trials, I’ve been monitored very, very carefully.

And that I think that they have been very, very honest. The doctors have been very honest. You know, that This, this is a trial. We haven’t got any definite results. It has worked on some people but we’ve, we haven’t got a percentage of who it works on [sighs]. And I was told that the chances of the Taxol one working that it was a fourteen per cent chance that that would work. And my attitude was, Well, somebody’s got to be in that fourteen per cent I wasn’t in that fourteen per cent. That one didn’t work. But I wasn’t given any percentages on this one, because it is a phase one trial and I was only number twenty-six. So I knew that it was a very, very sort of new trial, and I was prepared to take that risk.

And I would say to anybody that gets into these big, gets into these big things, Over a long period, don’t be discouraged if it goes a little – give them time to sort it out And they do, they do sort it out. The, actually I was right the way through, when you go up there, you present yourself at the desk and you tell them your name and they sit down, and you sit down there quietly for ten minutes or so. And the nurse comes up and she goes like that [raises hand], and that’s a signal to come with her. So you go with her. And you take your coat off, she never says anything, roll your sleeve up and you’ll sit there for a few minutes, then she’ll take your blood pressure. Right? So what she’s done, she’s created a tranquil environment from which to find out what your blood pressure is at that particular time. And they always come out 130, 134, which is ideal from their point of view. But one time I went up there, there was, I think she was, she was very pleased with herself, a sister whos qualified, looked like she’s just qualified. And I went and sat down and she started an argument about women’s lib. So she said to me – what did she? Oh, Women can do what men can do I says, What you talking about Well, they can change your boyfriend or whatever it’s not the kind of argument I like. And she went on and on and on and on. And then she took me blood pressure and it was 150, you see [laughs]. So that’s the sort of thing, it’s one of the essentials. Blood pressure’s a very uneven thing. It responds to all kinds of mood changes, noises, somebody’s voice, everything, every, all of those sort of things. So that what you’re doing is you’re looking for to create a tranquil environment in order to test the blood pressure under those circumstances. And that forms the basis of your evaluation, you see. And another time they said to me – oh, I’d been going there – Would you, have you, do the Edinburgh step test So I said, Well, I’m not into Scottish dancing. What you talking about They said, well, what they do is they take your blood pressure and then with the thing on walk you up and down a step, walk you up and down steps. And what happens it causes your blood pressure to go up. And then you stop. And then they see how long it takes to go back to normal, which I think was a very sensible thing. And it went back to normal, as soon as I stopped breathing heavily it went back to normal. So I thought, Well, in that respect the medication must be working Right? Because a doctor can’t prescribe for every mood you have, he just can’t do it. it’s impossible. He’ll go for the average and give you that test, and that test will show you how long. They deliberately put your blood pressure up and then they stop and it comes right down to normal. So from that respect it would seem to be a success.

I did sort of feel a little bit that – I know he’s a very busy man, I never saw that chap again after the time I said I’d like to go on the trial. And I sort of thought, Yes, okay, you’ve sold it to me and now you’ve gone Because the funny thing was family members had said, Wow, you’re going to get really looked after. A professor. And, you know, he’s doing all these studies and he’s really well up on cancer, in a cancer hospital. You’re going to get so well looked after And I tended to think that as well. That was one of the plusses. So that even if I hadn’t had the drug, I was on the trial, I would be really well looked after. I did sort of feel that once I’d made that decision, it was a bit like buying a car, the after-sales service, I thought, it was, it was okay. I mean, I can’t say I complain about it. I did feel that you were rushed. You, every time you went every three weeks to get your treatment you would not have a lot of time to talk about issues. It was a quick tick list. Have you, hows, how bad are your feet? How bad are your hands? Have you had the runs? How often have you had the runs Which is why they’re, they obviously have to take that for their own records, and if it had been too much they might have reduced the dosage. But I was lucky, really, that they never affected me that badly until the very last cycle, when obviously it accumulates into your system. I was very lucky that it didn’t, it never sort of stopped, I never had to stop, and I never had any reduced, apart from the last dosage. But I did feel that because of – and I assumed that – the strains on the NHS, the amount of cancer patients going through that hospital, they didn’t have a lot of time for you to discuss your worries. They did have a phone call line you could ring, but often you’d get an answer machine and they’d ring you back. And if you were worrying about something, that seemed an increasingly long time to have to wait to get an answer. Because we were told, Come to us. don’t go to your GP because they won’t have a clue about what you’re talking about. We understand the symptoms. We’ll be able to tell you whether that’s something apart from the treatment or whether that’s linked to what, the treatment you’re having So I did sort of feel a bit – but that I could understand, they’re very, very hard pushed, there were a lot of patients going through that hospital. So I understood it.

And then the last trial was very recently, which is, I have irritable bowel syndrome, not – it comes and goes, I mean, I can be perfectly normal for months, and then I can get attacks. And so there was a local researcher in the university I was working who was doing a trial of pro-biotic yoghurt versus plain yoghurt, not pro-biotic yoghurt, to see whether it controlled the symptoms of irritable bowel, and I was eligible and I signed up for it and it required you to drink, to eat two cartons of yoghurt a day for six months, I think it was, or – I can’t even remember. It was a long time, I remember feeling quite yoghurted-out by the end of it. And you’d just pick up your yoghurts in boxes with a number, you know, LR0911 on the top or whatever it was, and had to fill in a diary about how you felt. And I was interested in doing this trial because I’m interested, I’m actually interested – I’ve just switched jobs – I’m interested in the public running trials on themselves, you know. So people who like myself were interested in generating knowledge, we’d get together and we’d do it. And I just wanted to see how easy it was, and actually it’s, it’s quite difficult. You forget to fill in the diary and you think, Oh, what was it last Wednesday? or you scribble it on a piece of paper because you don’t have your book with you because you’ve gone away and, you know, you really don’t feel like a yoghurt but you have to eat it, and I was very compliant, I’m sure I was much more compliant than most people, just because there’s part of me that’s a bit of a researcher and so it makes you realise just how much noise or rubbish must be put into trials really because you’re thinking, you know, What was it? And then I’d think, Oh, well, I remember and then I’d find my bit of paper and it wasn’t true. Then I’d have to go back and change it, you know. So, but if I hadn’t found the piece of paper that misinformation would then have been put in. You had to, how many stools did you pass and what, how firm were they. There was a little chart where you had to categorise your, [laughs] your stool and this sort of thing. And actually during the whole period I was asymptomatic, and I was actually quite interested in how the research nurse dealt with me, because she, I think she was frustrated because there were no symptoms.

And also I was neither better nor worse and so the other half of her was wanting me to say I was better, when I didn’t necessarily feel I was better, I just felt I was unchanged. And I felt people were wanting a certain result, I really did get that impression, so I thought it’s, you know, it’s really important that staff are blinded as well. They can’t, you can’t help but want a result, that what nobody wanted to hear was, Well, I’m just the same. You know, I haven’t noticed any change at all, you know, so which is, was my situation. Later they told me that I had been on, on the pro-biotic yoghurt, which was a good thing because I was asymptomatic and I remained asymptomatic. So, who knows? Well, I say it was a good thing, but who knows whether that was, I haven’t seen the results of the trial yet, so.

Very difficult isn’t it? Particularly with those self-report kind of conditions–

Yeah,

–where there’s no sort of objective kind of, you know, like a tumour size shrinking is in a way easy to measure, isn’t it, but something like that?

I really think these things have to be blinded from staff as well, because you can’t help, I mean, if you’re running a trial, I want to run a trial, you can’t help wanting the result, because you, you wouldn’t be doing the trial unless you believed your intervention was effective, really, I think. Although they say you’re supposed to be in equipoise*. I don’t think you would ever begin a trial unless you actually believed there was good grounds to think that this will work.

* FOOTNOTE: ‘Equipoise’ means a situation where clinicians are uncertain which treatment is best literally it means they are balanced equally between them.

What kind of follow up was there to check whether it was working, what the outcome was?

I think, and again it’s only vague memory, but I think I got a letter six months after I started taking the tablets, and they asked me about all the things, you know – was it, was it affecting my work? Was it affecting my… hobbies? My sex life? Lots of things about the, how it was, how it was affecting me, and… again I think I got another letter about six months later. Probably, yeah, it was probably about a year after the whole thing started, I thought, This is, you know, I’ve got – this can’t be what I’m going to be like for the rest of my life So I think then I went back to my GP and said, Look, I want something else, please

So was it making no difference to you at all, as far as you could tell?

don’t think it was. I think at first it did, but I don’t think it did after that. Probably for the first – but again it could be psychological. I could be thinking, Great, you know, I’ll be alright, I’ll be alrigh, and then it probably, maybe it didn’t after the first couple of months. It probably, the whole thing was justI don’t think it affected me at all.

And I was given the diagnosis, which I hadn’t been given before, of borderline personality disorder by the psychiatrist. And I went into treatment, which was a five day a week therapy programme, which involved different groups and individual therapy. And I found out that the treatment was using something called partial hospitalisation, which meant that you weren’t in hospital but you weren’t out of hospital. You were kind of as a day patient, really. I did that for two years. But the treatment itself was focused upon a new approach developed by my psychiatrist, who had a very strong academic interest in psychiatry, and it was called mentalisation-based treatment.

And mentalisation was basically focusing on how you think about things, and about how you view other people. Because in borderline personality disorder you see the world as one way. It could be black, or it could be white. Somebody could do something and it will either upset you or delight you, but there’s no stable area in between. And also you only consider your viewpoint and it can be quite difficult to take on the other person’s viewpoint. So if somebody, for example, was late meeting you, you may think that they’ve not turned up. But maybe their car broke down or they couldn’t get to a phone or something happened. But as part of the illness it was difficult to take that on board, because your cognition, as they say, were kind of, it was somewhat impaired, which went back to all sorts of theories. There’s all sorts of theories about it.

But the treatment involved shifting that distortion, so that you were able to think about that, and think about other people’s responses and how you interact with people better and can then hold and maintain relationships.

The treatment that I went into, unbeknown to me at the beginning, was part of a clinical trial. And I wasn’t entered into the trial without my knowledge at all. In fact there were regular discussions in the day hospital about the trial, and what they were doing, and that they encouraged new people joining the day programme to come into the trial. You didn’t have to. It didn’t, wouldn’t affect your treatment whether you did or if you didn’t. But they wanted to show, to have as much evidence as possible to show after a period of time that the treatment worked. So I was encouraged to come into the trial. And what that involved was that I was given quite a lot of questionnaires to fill in. And at times you just didn’t feel like filling them in, but it was really quite important, because it monitored all sorts of things round your mental state, about whether the treatment was working or wasn’t. And it was quite interesting. And then I was also interviewed by a research assistant who had no access to my clinical notes or clinical care, where I was, every three months. So I would sit down and answer certain questions.

There were, some questions were open questions where I could prattle on for ages, and other questions were closed where they wanted, Ye or, N. Some was quite qualitative, where it was about how I was feeling rather than anything quite fixed. And, you know, and then there were other parts, which was more quantitative, where I was asked to score things on a score of 1 to 10 type thing. And it was part of the questionnaires and interview process.

What kind of things are they interested in asking you about?

Well, it’s very much like the social services check list. Motor, the symptoms of your condition, how are they? How do you manage? it’s the same form over and over again. it’s a repetitive one. How is it affecting you? Are you taking longer or how long does it take you to do various things? How is it affecting your relationships and your emotions and? it’s quite thorough but it’s very, very similar to the thing, when you have to fill in for disability living allowance and things like that, yeah. it’s quite similar to that. it’s not the same and I don’t feel pressured, so yeah.

I think the bit about how it affects your social life and emotions and family is quite an important one, and I can understand that they want to keep monitoring that, because with a regressive conditionthings could change quite dramatically, although for me they haven’t, but yeah.

Well, the questionnaires – this is a, [sighs] another thing that I think is not entirely clear. There is something called a psychosocial study which is attached to this trial, but it’s called a quality of life study in some other places, so I’m not sure exactly what it is. The relationship between the trial and this other study still isn’t clear to me. I mean I sat down, you know, yesterday to read through everything, and I still didn’t really understand it. But in the control group, what you get is two questionnaires three and a half years and seven years after recruitment. And there seems to be quite a lot of emphasis in this study on women’s attitudes to sexual activity, which I find surprising, because it seems to me that if you’re looking at the effects of taking part in a trial like this then, for example, you know, being anxious about getting these high level blood test levels, or whatever, that’s going to have a general effect on your life, rather than necessarily a specific one. So I couldn’t quite understand why there were so many questions about sex, and not so many questions about the impact on one’s general level of well-being.

And do you know with the control group how they’re going to follow you up at the end? Are they just going to do it by linked records with your GP?

Good question. Not clear [laughs]. I imagine that yes, the main outcome is, is cancer, ovarian cancer-related deaths, so that’ll be, they’re not relying on the participants to give them that information. They’ll get that anyway.

But the outcomes to do with psychosocial morbidity, or whatever you want to call it, will be derived from the questionnaires, which is why it’s important that the questionnaires should be about the issues that women themselves consider to be important. And I noticed at the time that on the trial coordinating group there were no ‘consumers’, whatever that means. And also I think that this study would have benefited from having a sociologist involved, somebody who has experience in research in health and illness. But, you know, it’s easy to be critical. I’m very pleased that this trial is happening. I think it’s important to say that there should be large enough studies to answer any questions about these kinds of strategies for preventing important causes of illness and death.

Do they ask you anything about side effects?

No. Not at all. No, not at all, which I think is a bit strange.

So just remind me what kind of things they do ask you about when she calls.

They always ask me if I smoke, if I’ve carried on smoking. That’s one of the first questions, which I hasten to add I haven’t. I haven’t had a cigarette since before my operation. They ask me if I’ve visited the doctor, how many times I’ve visited the doctor in the last year, how much time I’ve had off of work. That’s really it, basically. I would have thought they would ask you about your weight for a start, and maybe your diet, because it must sort of attribute to it really, because the problems that you get with the bypass are not just smoking-related. it’s diet, it’s your lifestyle, stress, all sorts of different things. But they don’t really ask. I would have thought they would have asked me a lot more, a bigger picture of the lifestyle that I’ve got, but they don’t. I don’t know why.

Yes, it’s very interesting that they don’t ask about the scar–

Or if I’ve got any–

–pains or —

Yeah, no, they don’t ask. I did mention that once and she just said to me, Well, you’ll have to go and see your doctor Because I did mention that early on in the trial, I said Oh, my skin is just alive, it’s just on fir, and she said, I’d go to the doctor But I thought that they would ask that sort of thing, Am I getting any problems They do ask me if I have suffered from angina, have I had any angina, which I hasten I haven’t.

No.

Not since before my op. So that’s a good thing.

I hope they will tell us the results because I would be really interested to know. They have been in touch with my GP since to find out how I’m going on, so they’re following my progress, and presumably they know the illnesses I’ve now got to cope with. And it’ll be interesting to see, you know, if anyone else is in a similar situation.

Are you actually going for follow-up appointments with them where they ask you what your health is like now?

No, no. I just had a letter from the GP saying she’d had a query from the people doing the trial, and was it all right for her to give them information and I just said, Yes So that’s, that was it.

Okay. So they’re not contacting you directly.

They haven’t done, no, no.

When did the trial actually happen? Which year was that?

When I entered it was, it was the very beginning of 2003. It might have been the end of 2002, because I had – it must have been the end of 2002, because I actually started the course on the first, first of January or the second of January 2003. It was the month of January I went.

Do you know how long the trial is going to be running?

No I don’t.

So you don’t know when you might expect to hear results?

No, no, but now that I’ve thought about it I might ring up and try and find out.

Did they say anything to you in the information they gave you at the start about whether you would get feed-back on the results?

I can’t remember now, and I can’t find the stuff. I don’t know whether I kept it or what. I can’t find the original information I had.

And what would you say to health professionals about why it’s important for people to have results of trials?

Well, I think if they’ve been good enough to take part in it, then I think that, you know, if they want to know the results they should be able to get them. A lot of people, of course, don’t, don’t want to. they’re not interested. But I would certainly like to know what’s happening. Yeah.

I ought to say something else about this trial as well. One of the things about this trial is the number of pills you have to take, and the regime of taking them, which can be a bit daunting. Because the trial drug, the lapatinib, you have to take five quite large tablets at least an hour before breakfast, or an hour afterwards, but it’s much more convenient to take them before. So about half past six – I have measured them out carefully the night before because the thought of measuring five at half past six in the morning when I’m fairly bleary is not to be countenanced.

So there they are waiting for me, and some time in the region of between six and seven I will take that. The chemotherapy I have to take with food, as well as tablets that stop soreness in my mouth – oh yes, that was another thing. The other side effect was awful, awful sores on my mouth. I thought it was because I went to Spain on holiday at the beginning of my treatment, the trial treatment, but in fact, that may have exacerbated it but certainly I do have stuff for that. So I take those, but I have to take them also during the day, so I have to make sure I remember to take them, and then in the evening I have to remember to take my chemo plus these other two sets of drugs, and then thereafter I also have to take [coughing] my iscador, which is a very interesting homeopathic remedy and which has been around for 60 years, and I have to take that in the morning after one hour from my Tykerb – my lapatinib which is, Tykerbs another word for it, and at least twenty minutes before breakfast. So it’s quite complicated. It’s like having a full time job, really, and not everybody can cope with that, but it just has to be, and there we are.

I measure out the tablets and things each time I have a meal. After breakfast I will measure out my evening tablets, and also the other thing is that I have to take my empty tablet packets back. As the oncology nurse said at the very beginning, You might have given all your tablets to the cat, we’re not to know that, but we do like to have the empty packets back again. So I religiously save those and when I’m on holiday I’m taking chemotherapy I have to make sure that they come back in my suitcase.

I take four tablets in the morning, four in the evening. They’re rather big tablets and rather irritating, annoying to swallow. They sometimes get stuck in your throat and you have to take a big swig of water or eat a bit of bread or something to make them go down.

But they’re not, it’s not like having to have an injection every day.

No. Presumably they could deal with that just by halving the size and taking more of them, couldn’t they?

Well, they could, and I asked, like many of the other patients, I said, Why do we have to take these great big horrible horse tablets when it’s obvious when you look at the tablet that the thing is only half, the capsule is only half-full. And they said, Well, yeah, we understand the annoyance. But to change the formulation, even in that trivial way to make the tablets half size, would cost them a year in terms of getting all the approvals and checking the pharmaco-dynamics and so on. And the economics of drug trials, as well as the urgency, mean that that’s not really worth it.