What would you say to other people who may be watching this and whove been invited to take part in a trial and are thinking about it? What would your message be?

Give it serious consideration, get as much information from your consultant, oncologist, whoever’s talking to you about it, talk to your family about it also. And again, as I said earlier, I think a lot will depend on the individuals prognosis and how you view the best possible treatment that you can get. The treatment won’t be any worse, because if, as I said earlier, if you feel as a person that’s it not doing you any good or if it’s making, your quality of life is being reduced by it, speak to the doctor, speak to your consultant. If they see also that it’s having serious effects and negative effects, they’ll pull you out of it. So you always have the option of stepping back from it. But do give it serious consideration, because you will be treated well. There is the aspect also that a lot of people say, Well, if you’re in a clinical trial you get better treatment I don’t know if it’s a case of getting better treatment. I think probably there are more tests done on you to make sure that the drug is not having a negative effect, so in that way perhaps people think they’re getting better treated. But I was involved in doing, as a part of the working group with the NHS Quality Improvement Scotland, doing the standards, reviewing the standards for lung cancer, and also for the core cancer standards, and that was one of the things that I got them to put in it was that just because you take part in a clinical trial doesn’t mean that, if you don’t take part in a clinical trial doesn’t mean you’re not getting the best of medical attention. So you are. But no, I would seriously give it serious consideration for taking part in a clinical trial, yes.

I think you have to remember that at any stage you can pull out of the trial, however far you’re in or how little time you’ve been in, and you have to trust people that that’s not going to compromise your care, although I do understand the concerns that people will have about that.

Depending on the person, I think you want to get as much information as you can about it. To keep an open mind, and not to feel intimidated or bamboozled into taking part if you don’t feel that’s right for you.

And just going back to that issue about your own care being compromised, you said, obviously there are some factual ways in which that might happen like you don’t get extra appointments that you get when you’re in a trial. Did you ever say, at any stage ever think that you were treated differently apart from that as the result of not taking part?

I think I had adequate care. I don’t think my care was compromised. I don’t think I would have personally benefited from any further investigations that I might have had if I’d been on the trial. In fact, I suppose I think you might even think that it’s even more visits to hospital and more treatments, and just when you’re beginning to recover, you know, yet more visits you might not want to. Although that’s what I’m saying now – at the time, it may be that when you’re so involved in treatment that you do appreciate that additional care.

Did you ever think about dropping out? Because that’s quite a long time, several years.

No, not really. I thought, If I’ve taken part I might as well finish it Yeah, no point in going halfway and then pulling out, because the research would probably flop. So no point. I think if one is to take part in anything, they should go all the way instead of leaving it halfway, because I don’t believe in unfinished business. I think you have to go to the root cause of everything, and sometimes that might get in the way. I think that’s how I am. I like to finish the things properly, not leave you in the lurch halfway.

And having been diagnosed, the first clinic that I went to, the first visit to the neurosurgeon was, he asked me if I’d like to do a drug entry trial which was being run from Birmingham. they’re trying to find out about – there are four commonly prescribed drugs on entry when you’ve, it’s been discovered you’ve got Parkinson’s diagnosed.

He rattled off the names of the four, which didn’t really mean a lot to me, except Sinemet which I’d known somebody whod had a really bad experience with. And so I said, Okay, what’s involved And he told me. He said, Well, you know, we, I would prescribe something normally, you won’t know, but in this case if you’re in the trial, I’ll phone Birmingham and they will randomly allocate you a drug which you then have to agree to take for- I think it was it was either a week or a month, I think it was only a week. –as a minimum. You must keep taking it And my husband was also involved. We fill in – there’s a follow up, so that we fill in questionnaires every six months, me from my perspective and [husband] from his as carer.

We did, and they phoned Birmingham and I got put on Sinemet. Oh, and it was absolutely awful. I really thought I was dying. It gave me very low blood pressure, so that when I stood up I fainted or fell back down. I had lots of falls on the stairs, disorientated, slurred speech, probably like somebody totally inebriated, as you’d say, legless. And I frightened a lot of people because my, my mother, whos dead now, but I went to her place and sat down on the sofa and of course I went to get up and I just passed out. So it wasn’t just me, it was very frightening for everybody else. However, we stuck it for the minimum, phoned and told them straight away, you know, that it was a problem. And I took it for the minimum, which I think was a week, and then went back and got changed to ropinirole, which I’m still taking now.

But I’d had, I think it was explained very clearly what was wanted, and obviously one hopes to get whatever it is that’s going to be the most effective. But if you’re going into a trial you can’t, you’ve got to accept the fact that you have what you’re given, you know. I mean, otherwise there wouldn’t be any point in having trials, and I am very keen on trials.

And when you were getting those side effects, which sounded really quite unpleasant, did you think about pulling out at that point?

Yes, but I knew that there wouldn’t be any point doing it if I did, so I carried on, yeah. Yes, if [laughs] it’d had been a free – [laughs] if I wasn’t in the trial – well, I wouldn’t have been on it anyway – but if it wasn’t for the trial, then I would have come off it sooner, but when you’ve made a commitment, you’ve got to honour it. I mean, you know, it’s not very comfortable, but there wouldn’t be any point in doing it, would there?

Had they told you could pull out if you wanted to?

Oh yes, yeah.

Yeah.

Yeah.

So it was a kind of sense of duty to them and to research and–?

Yes. Mm.

Mm, mm.

Yeah, it wasn’t pleasant but there was an end coming to it, wasn’t there? So, you know, it’s [laughs] you’ve got to be prepared to do these things, haven’t you, otherwise we’re not going to make any progress,

It was one day I thought I would, the next day I thought I wouldn’t. It was up and down, up and down the whole time. I started off categorically, Yes, I will go on this trial And the more I read about it and thought about the implications of those side effects – not just for a week or two but for a whole year – and the money side as well because, you know, you’re not offered any, anything as recompense for you losing your time off, losing time off work like that. I was very lucky I had an employer who was very on board and very supportive, very helpful. So I think it was about, it was about right really.

Did you ever think about dropping out while you were taking part?

Yes, I did. And I was told I could do that. I was told that at any point throughout the whole trial, if I decided that I’d had enough, for whatever reason, they would not, they wouldn’t want a reason, I could just pull out at any time. There was no pressure on me to continue. Although I did say to them, Then how does that work with the trial Because you’re on the trial, you haven’t completed the trial, they’d then have to go back and start with somebody else. And that, and that’s one of the things that kept me going, thinking, If I pull out, it’s been a waste of time for them as well as me. I’ve got to do it, because if I don’t, they’ve got to then find somebody else to go through what I’ve just had to go through, and I’m halfway or whatever through it But I did, yes. And that was purely down to the side effects. They were so debilitating at times. As a strong person, I’ve never felt that ill in all my life. You know, I said to my children that I almost felt what it was like to live to be about 100, because that’s how old I felt at times. I was so, so sort of down about all the, the other side effects.

FOOTNOTE’ It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.

My first experience was slightly, a slight disaster. Well, what happened was that they took my blood pressure and it was over 200, so I was in the right place. They then gave me a medication, 50mg of atenotol [atenolol] I think it was. And that was all right. And then after two or three weeks, after I’d been up there two or three times, they put me onto 100. And I woke up one morning, I thought I was having a stroke, like bands of steel round your chest, I couldn’t breathe. I thought, Well, this is how people feel when they’re going to di you know. So I got up and I pottered about and I thought, Well, I’ll tidy the place u, you know. I like to if somebody comes in. And I couldn’t think what to do. And I sat by the street door in a chair, because I thought, Well, if I fall off the chair, somebody will see that I’m not very well Anyway after about half an hour it went, disappeared. So I thought, Well, that’s, that is, that’s useful So I phoned ASCOT and told them about it and she said would I come up right away? So I went up there. And he, I didn’t see the same doctor that had gave me the pills, but he had a look and he said, Well, I see you had been on 50. You went onto 100 and then you had the trouble And I said, Yes He said, Well, I’ll put you back on 5, which seemed reasonable at the time. Except that once you’ve been primed with 100 and you went back to anything below it, you got 50 per cent of the reaction that you did with 100. So I, I got the same thing back again. But I thought, so I don’t know if they were a lot of apprentices up there, but they should have known about that. They should, it wasn’t a new drug, it was an old drug – unless he was trying to do something for his statistics. And I was so annoyed about it, I never went back. I thought they should have known about that. That is something I thought they should have known about. I couldn’t expect them to know that it would affect me adversely, because I’d never taken it. But once I had taken it and the pattern begin to emerge I thought he would have said. I saw it, and I don’t know nothing about medicine. Anyway I never went back.

Then I got a phone call. I think it was from [doctor] enquiring why I hadn’t turned up. So I explained to him what I’ve just explained. And I just had no choice other to explain it completely. No watchwords. Just tell it exactly how it happened. I said, And quite frankl I said, I was a little bit alarmed about it I said, Because if you look at it, I’ve come to see you quite well and finished up in a sort of personal disaster Anyway he explained it to me. Over an hour he was on the phone. And I was determined not to go back. But he was so, he was like he was treating me like I was somebody rare. So I thought, Well, I must honour his concern for my welfare So I went back again. And he put me on another medication, that I took right the way through all the years I was in there. And it worked. So I was glad I went back. So the important thing with this is that if you go on one of these long projects, these clinical trials, don’t be discouraged if something goes wrong. Because it’s the overall picture that counts.

FOOTNOTE’ It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.

And when did they tell you what the actual treatment involved, having to take these injections?

At the – now, I’m just trying to think – after the scan, after the results of the first DEXA scan when I went back to her. And it’s a few years ago now so I’m just desperately trying to remember the sequence of events, and so much has happened in those years.

This was ’02.

Was there ever a point when she said that to you that you thought Ooh, maybe not, actuall?

[Laughs] No, I get myself so far into things, I don’t like to back out [laughs]. I didn’t want to disappoint her, because she was saying Oh, it’s wonderful you’ve come forward, so few people hav [laughs], so you feel a bit obligated, don’t you? I do.

So you, you really felt kind of that you had a duty to them to —

Yes.

–to carry on? I mean it’s interesting that so few people took part. Do you think maybe that was because what they were asking was actually quite a big ask?

Oh, I’m sure it was, yes.

And if I was a bit braver perhaps I’d have said no as well [laughs]. It was just such a nuisance. I even had to go on holiday, abroad – in fact it was my honeymoon -and I had to take the injections with me and have a letter to show at customs, in case they thought I was a drug addict.

[Laughs] So, just tell me a bit more about the actual process of doing it. What was it like having to take these injections?

I really had to steel myself. Every day I had to steel myself to do it. I’ve got a bit of a big tummy anyway, but I could still feel everything, taking a lump of stomach and [gestures] – like that. Oh, swab it, of course. And oh, I don’t know, it’s making my mouth go dry. I don’t know if it’s fear or what, but I was doing that, as I say, for months before I realised that I really, really could not cope any longer.

I didn’t realise what it was involved in all this, because I had to inject myself, into my stomach, which I found quite a pain, because I had never injected myself before, as a lot of other people haven’t, obviously. There was – yes, so I was having to do that morning and evening to start with, twice a day, then it went on for quite a few months. I was prepared to do it so long as – then something happened in my life, a very close relative was in hospital. The smell of this – I didn’t know if it was a placebo, nobody told me if it was the real thing or a placebo, but I was pretty sure it was the real thing because it just smelt different – I just found I couldn’t do it any longer.

And when you went to them and said, I’m sorry I can’t continue any mor, what was their reaction to that?

Oh, they were very good about it. they’re probably used to people giving up on these things.

There must be lots of reasons why, but I thought this was a – I know I was not that keen on it in the end, anyway, to say the least. But that was really the deciding factor was having a member of the family very ill and having to smell the hosp- – I know even working in the hospital you get used to it, but it’s just on a different level smelling this. it’s terrible. it’s just making my mouth dry and my stomach wobble.

And they asked me if I’d like to go into this trial where I would either have the, what they considered the normal treatment of every day for a month, or every day for two and a half weeks, except for at weekends, of course. And [coughs] it would be, you would have no choice. It would be – what’s the word? I’ve forgotten.

Randomised?

Randomised, that’s it. It’d be randomised so that I would be in one or the other. Of course, I was hoping I’d be in the two and a half days [weeks], but unfortunately I was in the full month. Previously, the consultant had said to me that some centres use the two and a half weeks as their normal standard treatment, and it did occur to me that perhaps I could drop out of the trial at two and a half weeks, and then I, you know, I’d get what I wanted [laughs]. But I didn’t do that. I carried on and had the whole lot.

Now, I do regret it now that I didn’t stop at two and a half weeks, because I’ve discovered since that my lymphoma is extremely sensitive to radiotherapy, because I got trouble with my salivary glands last year, and they swelled up, and they discovered there was lymphoma in them. But I already have Sjögren’s Syndrome which was affecting the salivary glands, so my glands don’t hardly produce any saliva anyway. But they swelled up. And so eventually, my consultant said, We’ll try some radiotherapy So they put me down and I think it was supposed to be, as far as I remember, five sessions of radiotherapy. I went for the first session, and that night my glands swelled up even more and became extremely painful, and so I was supposed to go back the next day for the next treatment and they told me not to come to – by the morning they had, the pain had gone away so they told me they’d leave it for a bit. And eventually, I think it was about a week later, I had a second dose and luckily there were no bad effects that time. But the next day the glands were completely flat, so I didn’t need five sessions. It worked in, in two. And I mean the consultant couldn’t believe it when he saw me, how well it had worked.

So it’s only with hindsight now I think if I had had the courage to stop after two and a half weeks, I probably would have been perfectly all right. And also I wouldn’t have the lung damage which I’ve got now which, you know, is due to the radiotherapy. So I’ve got bronchiectasis and pulmonary fibrosis. I get very, very breathless, and I feel if I’d stopped at two and a half weeks I probably wouldn’t have been so badly affected.

And have you talked to anybody about how far that was related to the, the treatment?

Well, they’re a bit cagey about saying that it’s [laughs], it’s related to the treatment. They say it might be and it might not be. But I know it is [laughs].

FOOTNOTE’ The radiotherapy Celia describes for Sjögren’s Syndrome took place after the trial and was unrelated to it, but it is this experience since which has led her to think that she is very sensitive to radiotherapy. This is why she feels it might have been better for her to be in the trial group having only the two and a half weeks of radiotherapy for the lymphoma.

Sjögren’s syndrome is an autoimmune condition, in which the body attacks its own moisture-producing glands, such as the tear and salivary glands. In some cases, other organs of the body are also affected, including the kidneys, liver, pancreas, lungs, blood vessels and brain.

Well, my first thoughts were that I was pleased that that this trial had been organised. Ovarian cancer is known as the silent killer, and the problem with it is, that by the time people have symptoms, it’s often too late to do anything, so this is clearly an area where some kind of effective screening could, in theory, prevent many deaths. So I was pleased that the trial was happening. And I felt that I ought to take part, that I had a moral responsibility to take part. However, my second thought was, I don’t want to be in the groups that are having these particular approaches to screening. And that’s quite interesting, because, as somebody who has actually, you know, organised trials myself, I know that the main problem with people refusing is actually amongst people who are randomised to the control group, who are dissatisfied and want to be receiving whatever intervention it is, and my attitude was different. I wanted to be in the control group [laughs] and not in the two screening groups. So I’m not sure what I would have done had I been randomised to one of the screening groups. I think I probably would have dropped out, and I would have argued to myself that since most people, as I’ve just said, most people who drop out drop out for the opposite reason, I would just be balancing numbers.

Can you imagine yourself in the situation in the future where you were diagnosed with something and how you would feel about having that decision?

Yeah. I would feel that I needed to check out the statement, We don’t know which treatment is best. And if that was really true, then I think I would say, Okay. It’s easier I think when, you know, what your – [sighs] well, no – I mean when the choices are between different treatments that are much the same in terms of physical side effects or inconvenience or whatever. If there was a big difference, as I felt there possibly was with the ovarian cancer trial, then I think it’s more difficult. You know, if being in one group means that you’ve got to go to hospital every month [laughs] and have something which hurts, as opposed to going every six months and having something that doesn’t hurt, then it is a decision with consequences.

Did they say to you could choose which treatment you wanted or you could stay in the trial and be randomised? Is that how it worked?

Yes, I could have stayed in the trial, yes, and they could have sort of monitored it, you know. Or they could, I think there was radiology. I think they talked about, I think there was an eight-week course and you had to go every day for eight, you know, and they built a shield so they didn’t damage anything else around here, you know. And I thought, Well, honestly, I don’t fancy that at all, you know. And, as I say, there was the random surgery. And the girl, the nurse, she says, Well, my advice, Ronny – well, she said she can’t advise me and tell us what to do, you know. She says, The decision’s yours. She says, but she, once she explained how, you know, she says, You are quite a fit bloke for your age, and I would think seriously about what you want to do. But And that was when I asked her. I says, What do you normally do? Can you put it on the computer? And I says, Is it fairly detailed, you know, detailed what they do? And is it, you know, they didn’t just hoy [throw] it up for you because they need to do some radical surgery on somebody, you know, sort of style? And she went away. And she came back and she says, It’s come up radical [surgery]. And I accepted it. And that was the 25th of November. And 13th of December I was sitting up in bed doing crosswords. Unbelievable, I cannot believe it. The night sister shook her head and walked out of the ward. She said, I don’t believe this. [laughs].

So if the computer, when they did the randomised allocation to which treatment you were going to get if it had come up with one of the other treatments, how would you have felt about that?

I would have probably went with them on the monitored. But I didn’t quite fancy the radiology one, you know, because they had to build a shield for you. And I know it sounds petty, like, but every day for eight or nine weeks going into the hospital, you know, I just wasn’t prepared. I just didn’t fancy myself doing that, I couldn’t see myself keeping it up, you know. But I, if the computer had come up with something different I would have probably went with it apart from the radiology one. But if it said random, I would have been, well, I would have been over the moon, wouldn’t I? I would have says, Oh, great, I don’t have to have an operation, I don’t have to come into hospital.

For the monitoring?

Because I had a aye. I mean I had a, I had never ever been in hospital, apart from football injuries when you’re a kid, and you know. But never stayed overnight or anything, you know, never had an operation. And I thought, Crumbs, they’re going to take the you know. But, as I said, the test, you know, the survey that they were doing is the best thing that ever happened to me. Because if I had, if I had ignored the letter, say I’d said, Oh, I’m too busy. I cannot be bothered to go round there, you know, I would have still been walking around with it now, but it would have been five year, five years further on and it might have been even worse, you know.

So if you’d been allocated to the radiotherapy group, you feel you would probably have dropped out of the trial?

Personally, yes, yeah. I don’t think I would have went with it. I would have came out there and I would have says, No, I’m not. You know.

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Within eleven months of that operation I found another lump, which again they removed and did a, did some more dissection, took more lymph nodes. And they sent me again to see the consultant, and they decided then that it was faster-growing than they had anticipated. They did CT scans and it was suggested that I went on the interferon trial. That trial was you’re either – we all had four weeks of intravenous interferon, and then some of us went on for another forty-eight weeks to have three, three injections a week, which were self-administered. And we were checked every three weeks to make sure that everything was going all right. And I managed to do a full twelve months, with some side effects – feeling very tired, flu-like symptoms nearly the whole way through, but I did still manage to work. I cut my hours down. I did four days a week instead of five, but I still managed to work.

And they thought that had, that was, things were going well. And then I was clear, that was 2005 I had the interferon. Then in 2007, in the September, I found another lump. And they did a CT scan and they decided that the disease had spread. So they needed to do something about it, but there was no, no set medication. I was offered a trial, and I had two treatments of that trial, and I lost all my hair on that trial, had a wig. I was devastated about losing the hair, but I had a wig and most people said it looked quite normal. So that wasn’t too bad.

But then found after another CT scan that it wasn’t actually working because there were five lesions, and it had shrunk, started to shrink one but none of the others were shrinking. So they decided that it wasn’t worth carrying on. So I was then told, Well, that trials not working And that is the only time that I felt really let down, because the doctor told me didn’t explain that, Well, that one’s not working but we can try something else It wasn’t until I was told, That one’s not working And I sat there and thought, Where do I go from here And I had to ask the question, Well, is there anything else And it wasn’t until I asked that question that, Well, yes, there might be other trials, but you have to have a break

FOOTNOTE’ Anthea has been in three trials. Here she is talking about the first two, a 12-month randomised trial of interferon, followed by a non-randomised trial of paclitaxel (Taxol).

I’m actually a doctor and I work in public health, and I was working in [county] and I was in charge, I’d just been put in charge of the diabetes strategy there, and so it made me interested in the fact that nearby they were running a diabetes intervention trial, and it was for people who were well but who might be at high risk of diabetes, so people with a family history. So I decided to just go along because I thought Well, it would be interesting and I’d be interested in participating, I’m interested in research. And what happened in that trial is they, screening well members of the public, are looking for people who had high blood sugars but not, not diabetic levels, to see whether certain medications would prevent diabetes actually coming on, so people who were at high risk of developing diabetes. And what really surprised me was I actually turned out to have the high fasting blood sugar, so I – which made me eligible to go into the full trial itself. And I, I hadn’t anticipated that at all when I went into it. I was just sort of seeing what they did and you go along and you have your blood taken. And then they called me back and I had the high fasting blood sugar, which meant I was eligible for the trial. At that point they said Where there any questions? and so I started asking the research nurse whether there are other interventions like exercise and diet which could help, and she more or less said no, and she was very vague, wasn’t very sure, but she didn’t think there was otherwise they wouldn’t be doing this trial.

So I was rather upset at the lack of information that was forthcoming, having had a high fasting blood sugar, and so I decided to go off and look it up myself, and so I went on and found out that, you know, diet and exercise actually do – you know, there are other things you can do as well as taking medications. And so I was a little concerned that the level of staffing at the trial, that their staff were so poorly informed about this – which was fine, I was still going to go into the trial. And then a routine visit to my GP, you know, just to get a renewed prescription and he had in front of him a piece of paper telling him I had a high fasting blood sugar, and I was really annoyed because I had not been consented for my GP to be informed anything about this, and at that point I decided I would not go into the trial, because I just didn’t think it was ethical that they had breached my confidentiality in this way, so I just withdrew from the trial and didn’t do it.

Footnote’ The UK Clinical Research Collaboration points out that current ethical guidance is that if you agree to take part in a clinical trial, all your trial records and any information that is collected about you will be kept confidential, in the same way as your medical records. The researchers cannot tell anyone that you are in the trial without asking you first.