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Jayne - Interview 03

Age at interview: 47
Brief Outline: Jayne had breast cancer aged 33. She wanted to join a clinical trial but her consultant was not interested, so she transferred to another hospital and took part in a trial comparing tamoxifen with tamoxifen plus goserelin (Zoladex).
Background: Jayne is a Consultant orthodontist, married to a GP, with 2 children, aged 8 and 5. Ethnic background/nationality' White British.

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Jayne had a benign breast lump removed in 1989. She could still feel a lump, and by 1994 decided it needed to be investigated again. She was diagnosed with breast cancer aged 33. At the time she was doing a PhD on clinical trials in dentistry, and had recently been on a course in London led by a breast cancer surgeon about the ethics of running clinical trials. During the course she was thinking that she would like to be included in a trial if the lump turned out to be malignant.
 
However, when she mentioned this to the consultant treating her, he said there was no doubt about what treatment was best, and she should ‘not let science get in the way of the best treatment.’ Jayne’s husband, who is a GP and knew how strongly she felt about it, got in touch with another breast surgeon at a different hospital and Jayne was transferred there so she could take part in a trial comparing the anti-oestrogen drug tamoxifen with tamoxifen plus goserelin (Zoladex), another hormonal therapy. She was allocated to the tamoxifen-only group. This meant taking a tablet every day for two years, whereas with Zoladex she would also have had an injection once a month. Tamoxifen gave her several side effects, including hot flushes, weight gain and disturbed sleep, but she was determined to keep taking it and stay in the trial so that others could benefit.
 
Since the trial ended she has learnt that tamoxifen plus Zoladex is more effective than tamoxifen alone. However, she does not feel disappointed or worried, because for her taking part in the trial was always about the wider benefits of research and helping future patients rather than personal benefit. Two of her friends have since had breast cancer and have been given tamoxifen plus Zoladex, so she can see a real benefit for them.
 
Jayne feels that unless people feel really strongly that they do or do not want one of the interventions in a trial they should think about taking part. Trials are important to check for certain if new treatments are better than older treatments, and are only allowed to go ahead with approval from an ethics committee. She thinks health professionals have become much more aware of the importance of trials since her own experience, though there is still some way to go in establishing trials of non-drug treatments such as surgery or physiotherapy. In her own discipline, orthodontics, attitudes have changed, and she herself runs trials regularly. Jayne feels that if you are upfront and explain to patients that there is genuine uncertainty about which treatment is best, they will understand the need for research. Greater public awareness would help.
 
 

When Jayne learnt she had breast cancer in 1994, she knew it was unclear which treatment was best...

When Jayne learnt she had breast cancer in 1994, she knew it was unclear which treatment was best...

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Less than a week after the operation [removal of a breast lump] my husband rang to see if the pathology results were back and we were asked to come in to see the consultant the following morning at 8 o’clock. And you know at that point that if the consultant wants to see you at 8 o’clock in the morning it’s not good news.
 
So that was a really anxious night, and true enough on the Friday morning he told me that the lump was malignant. Now coincidentally I’d just started my PhD, which was looking at clinical trials and my own discipline [dentistry], and I’d gone to a course on the ethics around clinical trials down in London. So in between having my surgery and having my diagnosis I was on a course, run by a very well known breast cancer clinician and a lady that worked at the Cancer Research Campaign all about the ethics surrounding clinical trials and recruitment etc, etc, and the example that they used was breast cancer.
 
And I was sitting in the audience thinking, “This will be me next week”, and then it was – except for it wasn’t next week, it was a couple of days later. So at that point I’d already, in the back of my mind, I think, decided that if my lump was malignant I wanted to be in a trial and there was no question about that, because of what I’d heard on the course, what I knew from my studies, that, you know, that was the way forward. But when I raised that with the consultant that was treating me he said quite categorically that, “Well, there’s no decision about how we treat you. You know, do x, y and z.” But I’d had the whole three days down in London knowing that treatment of someone with early breast cancer under 50 is not a question of x, y and z, that there’s a lot of uncertainty, and I knew of this trial, you know, the under 50’s trial. So I said, “Well, I’d like to be involved in the trial. You know, can I be involved?” And at that point he said that I mustn’t let science get in the way of the best treatment for me. And all this conversation was taking with me still stripped off to the waist with a little towel across my chest lying virtually flat on the bed….
 
I certainly wasn’t happy with that and I don’t think my husband was either, because he knew that I was very pro clinical trials. So that was the Friday and on the Monday he rang up a breast surgeon at another hospital who had been his consultant elsewhere when he was a medical student, and he arranged for me to have my care transferred to this other unit. And he was involved in that clinical trial, and knew about it, and knew the people who I’d been on the course with, so everything went quite smoothly.
 

Jayne is strongly committed to the value of research and wanted something good to come out of her...

Jayne is strongly committed to the value of research and wanted something good to come out of her...

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Why are they important? They’re important because you’ve got to establish whether the new treatments or new regimes of treatment are better than the existing therapy, and for every new therapy that’s better there’s probably one that’s the same and another one that’s worse. So you’ve got to find out whether the new one is an advantage or not. It’s not just a marketing thing - it’s got to be done scientifically. So for any new treatment, be it a tablet, an op- - what amazes me is that operations aren’t subject to clinical trials, really, or haven’t done until recently, and certainly the treatments in my discipline aren’t.
 
But drugs were, and this was a drug so it had to go through a clinical trial. So I think they are really important from that point of view. Why did I want to take part? Well, there’s probably no point in having a disease like that if you can’t get any good out of it. You know, at the end of the day it’s pretty, it’s not a good thing to happen when you’re 33, and if there’s anything good that can come out of it, well, fine.
 
Quite often I hear people talking about the good that may come out of a trial being in terms of personal benefit. It sounds as though that wasn’t your perspective.
 
It’s, well, it’s not personal benefit, because you in the trial don’t really benefit from it - although there was some evidence at the time that people in trials, whether they’re in the winning arm or the losing arm, do better than people outside trials because of the added extras, the extra attention et cetera et cetera. But I think more recent studies have shown that there probably isn’t as much difference now as there used to be. Whether that’s because - well that’s probably because the routine care - or I would like to think it’s because the routine care has improved and people are, in clinical trials, aren’t as different, and labelled as different. But I suppose that was in the back of my mind, that I hadn’t really got anything to lose and... there was something to gain from it in the added information, but since I was diagnosed I’ve had two friends who have been diagnosed with virtually identical conditions and they’ve both had the tamoxifen and Zoladex, so I suppose that trial has helped my peers, if you like, who have been diagnosed ten, twelve years later.
 
FOOTNOTE' There has been some evidence that people who take part in a trial – whatever treatment group they are allocated to - have better health outcomes than people who do not take part in trials. This is known as the ‘trial effect’. However, more recent reviews of the evidence have shown no significant differences in outcomes for people given similar treatments within a trial or just as part of their normal care. 
 

Jayne explains that blinding to patients and staff is not always possible, but you can still make...

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Jayne explains that blinding to patients and staff is not always possible, but you can still make...

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Blinding is so that you – well, if possible - you don’t know whether you’re getting Treatment A or Treatment B, but in a lot of trials that’s not possible because there are differences in Treatment A and Treatment B. In the trial that I was in, one was a tablet and one was an injection, so it’s pretty obvious. So it’s not always possible for the patient to be blind, and it’s not always possible for the clinician to be blind because they know whether they’re giving an injection or whether they’re writing a prescription, or in our case whether they’re fitting the different appliances. But what you can do is to get an independent person to look at the outcomes, and that’s probably the - I mean, if everybody’s blind to it that’s great, but if an independent person looks at the outcomes they don’t know what treatment the patients had and that’s how we get round it in our discipline [dentistry research] because we, a lot of our outcomes are assessed from photographs, models or x-rays, and you can blind them to the person that’s looking at them or measuring them.
 
So they have no idea what happened?
 
No, which – yes, because again people have in-built prejudices and they think that Treatment A is going to be better, so they sort of want it to win, so they might measure it slightly more favourably.
 

Jayne is in favour of more trials in surgery and her own field (dentistry), but explains why it...

Jayne is in favour of more trials in surgery and her own field (dentistry), but explains why it...

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The number of clinical trials that are published in surgical journals now has almost gone up exponentially, so I think even the surgeons are accepting uncertainty, and new surgical procedures are getting trialled against existing surgical procedures.
 
I suppose it’s one thing to accept uncertainty within your self and another to express that to patients, maybe.
 
Yeah, I mean you’ve also got collective - individual uncertainty and collective uncertainty*, so surgeon A may swear that operation A is the best, and surgeon B may swear that operation B is the best and that’s fine. But you’ve got to compare the two operations done by as many people as possible. And that’s where I think a little white tablet you’re finding out which tablet or regime does the greatest good for the greatest number of people, whereas with any surgical procedure or something that’s dependent upon clinicians’ skill you’re looking at what does the greatest good for the greatest number of patients by the greatest number of clinicians, because if an operation is so, so complicated and difficult that only the most skilled surgeons can do, that’s not really useful for general application through a population. So you have to think more on population benefit rather than individual benefit, and I think in an individualist society that sort of attitude tends to get lost.
 
Mmm, and in --
 
Because everyone wants what’s best for them, rather than seeing the bigger picture of what’s best for the most people.
 
Yes, yes, and I think, I mean it’s still, it’s still hard for doctors, you know even if they accept all of that to actually explain that to the individual sitting in front of them, sometimes.
 
Mmm, it’s probably easier with the tablet than an operation. We’re coming to terms with similar things in our discipline [dentistry] which is again a very clinician-dependent one but - and we’ve got the range of different, like, braces and things that we can use - but as a profession we are becoming more comfortable about discussing these uncertainties, and more and more clinicians are prepared to enter trials. When I started doing my PhD there were hardly any clinical trials, and the ones that had been done were like testing different glues, which in a way is like a tablet - glue A versus glue B - whereas now they’re running really bold trials against quite different competing interventions.
 
* FOOTNOTE' Individual uncertainty here means that an individual surgeon is uncertain which operation is best for which patient. As Jayne explains, however, sometimes individual surgeons have views about which operation they think is best, even when there is disagreement or uncertainty amongst their colleagues as a whole. This is collective uncertainty.  
 

EastEnders missed an opportunity to include clinical trials in a story about breast cancer. But...

EastEnders missed an opportunity to include clinical trials in a story about breast cancer. But...

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I think public awareness needs to be raised and I remember thinking at the time that they missed a fantastic opportunity in Eastenders because - I can’t think of her name now - was diagnosed with breast cancer – Peggy Mitchell was diagnosed with breast cancer, and they could have brought that into the storyline brilliantly, fantastic education opportunity, because millions of people watch that. But that, that was a missed opportunity. So I think things like that that are in the public culture could be used for education and raising the awareness and people’s willingness to participate. But I think if approached properly and if it’s explained properly I don’t think many people would refuse to participate.
 
I think raising awareness within the professions is as important as raising awareness within the public.
 
Do you think there’s still work to do there?
 
On the - I think so on the non-medical side. I think physicians are used to clinical trials, they expect clinical trials, they know they’ve got to test drug A against drug B, but anybody outside medicine, so in any of the therapies, physiotherapy, or surgery, or anything like that were they don’t have to go through a trial to get a licence, it’s probably not in their professional culture to do trials.
 

Unless you have strong feelings about which trial group you would want to be in, Jayne advises...

Unless you have strong feelings about which trial group you would want to be in, Jayne advises...

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I’d say that unless you’ve got any strong feelings about a treatment you want or don’t want, I’d participate. …But there are, I think there are always occasions when the treatments are so dramatically different that some people will have an in-built priority. But I think the, the amount of work that goes into setting up a trial, unless, unless there is no clear evidence that one treatment is any better than any other, the trial won’t get ethical approval. And the conditions around registering a trial, getting ethical approval and funding and everything have so, improved so much over the last ten years, I wouldn’t have any qualms that what a clinician was doing was unethical, because I know the rigours that they have to go through to get approval and you can’t do a trial without approval, and all the protection that’s in, in-built in the systems now, when you’re running a clinical trial, that you have to give reports and, you know, show how people are doing. 
 
 

Jayne did not mind being in the control group, even though the new treatment tested in the trial...

Jayne did not mind being in the control group, even though the new treatment tested in the trial...

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I was given an information leaflet about the trial, about the drugs and the options, but the, once the consent forms were signed, it was, the randomisation allocation was done over the phone, from because it was a Cancer Research Campaign trial, so it was done through their headquarters, and then after that I got my tablets and started taking them.
 
I was allocated to the tamoxifen alone group, and like any trial there are advantages and disadvantages. The advantages of that was that it was just a tablet every day for two years, whereas the Zoladex [goserelin] one was an injection once a month for two years, or you could have them both together. So in a way I thought I’d got off lightly. But actually now that the results of the trial have been published, I think people in my situation now are routinely given the Zoladex, so I was probably not in the winning arm of the trial. But you don’t know that when you go into the trial and… there are side affects and risks of the Zoladex, which aren’t particularly pleasant, so everything’s a balance. So it didn’t worry me whether I was in the winning arm or not. It was the taking part that mattered.
 
Does it worry you now looking back?
 
No, I’m quite philosophical about it. So they, they didn’t know at the time. It was a new drug, can have nasty side effects, meant an injection every month whereas I, you know - no, I’m not bitter about it, no, not at all. 
 

Jayne explains the need for randomisation to have comparable groups of people in each arm of the...

Jayne explains the need for randomisation to have comparable groups of people in each arm of the...

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How would you describe the reasons for randomisation?
 
We’ve got to be sure that the patients getting Treatment A aren’t in any way different from Treatment B. Now, every clinician or patient has got their own in-built prejudices or biases, whether they’re aware of them or not, so to overcome those you have to rely on either a list of random numbers on a table or a computer-generated one where they haven’t got any feelings or instinct. They just spit out a load of numbers, and all the odd numbers get Treatment A and the even numbers get Treatment B. So it’s a way of ensuring that the people within each group are as similar to each other as possible, that there are no systematic biases or in-built differences, that they’re not all older or fatter or more educated or, you know, all blonde people or, you know, anything like that. They’re not systematically different.
 
And sometimes you hear people puzzling about why it wouldn’t work just as well to let people choose which treatment they had and provided there were large enough numbers and you collected enough information about different variables to control for when you analyse the results, why that wouldn’t work.
 
Because every individual has probably got in-built prejudices against one or other of the treatment options, and it may be that if you are of a certain type of person you would choose Treatment B and a different type of person would choose Treatment A, and therefore you get different types of person having the different treatments, and it’s the differences between the people that make the difference in the outcome and not the treatments. And when you’re analysing the data you can’t account for every known factor between the two types of people. You’ve got the crude things like age, socioeconomic group, sex, ethnic origins and stuff, but there’re all sorts of other subtle things that you might not record or have a valid way of recording it. But with randomisation they will be randomly split between the two groups.  
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