Kay - Interview 09

Age at interview: 23

Brief Outline: Kay has been involved in two clinical trials to test improved prophylactic medicines for cystic fibrosis. She describes her experience of taking part as 'fantastic'. Her advice to others thinking of taking part in similar trials is to be fully informed.

Background: Kay is 23 years of age and was diagnosed with cystic fibrosis at the age of two months and Diabetes at age 18 years. Kay lives with her parents, works part time for a charity, describes herself as Welsh and has an older sister who lives away from home.

More about me...

Kay is 23 years of age and was diagnosed with cystic fibrosis at the age of two months and diabetes at the age of 18 years. Kay lives with her parents, works part time for a charity, describes herself as Welsh and has an older sister who lives away from home. Kay has recently been involved in two clinical trials to test the value of improved prophylactic medicines. The first trial began two years ago and has just finished. This was a trial on Mannitol which is a treatment to help improve lung function. Kay describes her experience of taking part as ‘fantastic, it was the best experience’. All travel expenses were paid, her lung function went up and the treatment was quick and easy to take in comparison to her usual treatment, and it tasted nicer too. She says that her cystic fibrosis is more or less stable at the moment. Kay took part in the Mannitol trial because she was experiencing a period of poor health; her lung function had gone down quite a lot. She was keen to do anything that would improve her lung function and health. Kay was invited to take part in the Mannitol trial by a research nurse at the hospital where she goes for her treatment and check-ups.

Kay is now taking part in another trial to test Heparin. For both of the trials, Kay received plenty of clearly presented information and had the opportunity to ask questions. Her nurse checks to see how she is doing on top of her routine hospital appointments.

Kay feels that taking part in clinical trials is a good thing. She says, ‘This might be the future, I might be trialing the future treatments of those that are growing up with problems. I think it is quite nice to be involved in something that might benefit other people with cystic fibrosis.’ In terms of taking part in future clinical trials, Kay said she would be happy to take part as long as her work schedules and social commitments allowed as these are getting quite busy. With regard to giving advice to other young people who may be thinking of taking part in similar trials, Kay suggests getting as much information as possible, the reasons, pros and cons for getting involved, duration of the trial, how is it going to benefit you, will you be reimbursed for travel expenses, can you drop out at any point, what are the side effects and can these side effects be treated easily and make sure you are fully informed about the trial.

 

Kay was able to take part in a study to help develop a physiotherapy vest for people with cystic...

Do you want to tell me a little bit about the third study that you’re doing and how this fits in with your other one and...?

 

Through my job I was approached by a pharmaceutical company who’s looking, it’s an oxygen company, who are looking into the possibility of making it’s called a physiotherapy vest. So, quite a lot of people do manual physiotherapy or they use equipment as to do their physiotherapy as a way of bringing up their mucus and avoiding infections. Whereas this is a machine which is in, there’s a vest that you put on and air basically pumps into this vest and it vibrates your chest, like physiotherapy would. It aims to bring up the mucus. And they just want to know the feasibility of maybe bringing it into the NHS. How good it would be for different service users. And, you know, it’s quite an expensive piece of equipment. But if it’s only good for the minority then the NHS and the Government’s not going to be that happy about introducing equipment like that or is it going to be available by private companies like pharmaceutical companies. I do know people that have bought them but individual preference. I did like it to begin with but I find it very annoying now. It’s very loud and noisy and big and I don’t particularly like it, but...

 

So that wasn’t done through sort of your consultant or?

 

No, I liaised with my consultant and my physiotherapist and they were quite happy for me to trial it. But they don’t offer the vest in their centre just because it’s a very expensive piece of equipment.

 

And did they mind you doing that while you were on the Heparin?

 

No they actually said to continue using it because I need to keep everything the same so all the base line measure had kept kind of, the same. They know what’s causing what during the trial so I’ve kept the vest in the trial just so there’s no anomaly, anomalies because I’ve changed my physiotherapy regime.

 

She felt there was less information and less medical support in the physio study than in the...

Did you have kind of very similar sort of information that you had with the clinical trials done through the hospital or because this is done slightly from a more private?

 

Not as much information. That’s why I consulted my CF Team, the doctor and the physiotherapist. Because I think they go, the pharmaceutical side of things, they go for a more of a commercial way of thinking rather than a medical way of thinking.

 

That’s interesting to see the difference between the two, I mean, if you could, if there was a clear cut distinction between what would that be do you think going through the hospital and having this private or pharmaceutical led trial?

 

I well I definitely feel more supported medically if anything went wrong with my Heparin and Mannitol. Whereas if something went wrong with the vest I’d still consult my CF Team but I wouldn’t get medical support from the pharmaceutical company because I don’t think they’ve got that knowledge. They’re more a commercial company than a medical company so, I, not that I couldn’t ask for help from the pharmaceutical company because they are really helpful but they wouldn’t be able to offer medical advice.

 

Not knowing which drug you are taking can be scary, but having good clear information to read and...

And did you have a lot of information about it, was it written information?

 

Yeah, they usually provide kind of a pack quite a few A4 sheets of what is involved in the trial, how long it will be for, what they expect from you, what they will provide for you, and the purpose of them, of the of the trial, what information are they gaining from it and what kind of medical properties has that drug got. And all clearly explained so we had it written and we had a verbal explanation and it was all recorded in my medical notes. And obviously we’re told if we want to drop out at any time well we can and it won’t affect our standard of care if we do so.

 

And did it, what, you’ve explained about it being double blind and placebo can you tell me a little bit more about that and - because you didn’t know at the time?

 

No, to begin with they said, I think its one in four chance that it could not be the Mannitol drug. So one of them, so I think three would be the Mannitol, but they’d be different strengths and the one would be a placebo so it would be, it wouldn’t have any kind of clinical effect. So they said, you know, there is a possibility that you might not be on the drug but if you feel worse or you feel like you want to drop out at any time during the study, you’re more than, you know, you can. So I think if I felt that I was getting any worse I would have probably thought that I was, I was on the placebo, and I probably would have dropped out to be honest. But it’s quite a scary thing to think you’re trying something that you think is going to help but it might be a placebo but I suppose you need to take that risk sometimes if it’s going to improve your health.

 

And did it say about any side effects at all?

 

Yeah, it had contraindications for treatment and side, possible side effects. And obviously if I did have any side effects there was a diary that I could fill all these in or get in touch with the doctor or nurse at any time and then a decision would be made from there if to take me off the medication or to start new treatment so.

 

Taking part in the trial meant Kay would be closely monitored and any health problems could be...

I suppose they can be quite time consuming, if you don’t fit it in with your normal routine. I managed to fit mine in with my routine quite well and it was actually saved me time rather than anything else. But I suppose it depends what you sign up for, it depends what kind of medication you’re going on, or what kind of research you’re taking part in. And I actually quite liked being part of the study because it meant that I was kept, my lung function was kept an eye on quite closely and the bugs I was culturing were kept an eye on quite closely. And it means that if anything was picked up I could start on a new medication that would treat it so it was actually quite nice. So I was getting kind of really really, well I don’t know everything was kept an eye on quite closely and it meant that I could either change my physiotherapy regime like to increase it so that my chest would be better, or I could do more exercise, or the doctor could prescribe an antibiotic if I was culturing a certain bug. So I thought it was quite, I found it quite nice. But some people I don’t know, I’m quite conscientious with my CF and I like to do as much as I can, whereas other people might not.

 

Yeah.

 

So they might find it a bit annoying having appointments because of the trial and things but I quite liked it because it meant that I could.

 

So in a way you were getting closer treatment, closer, they were keeping a closer eye on you.

 

Yeah, yeah.

 

That kind of gave you a nice feeling?

 

Well it just meant that if my lung function was dropping it could be the problem could be looked at straight away rather than maybe leaving it a month and then think, feeling really really ill. So if I felt ill they could treat me straight away rather than maybe leaving it a month or so, and obviously prophylactic treatments are the way forwards so.

 

Trust in the health professionals was important to Kay when making the decision to take part (or...

CF care is quite a different to kind of other care and you; you do go for quite a lot of appointments in comparison to other conditions. You do have in-patient stays for a few weeks. You do, it kind of, you do trust them because there are so many different things that you go through with like I’ve been attending a CF clinic since, well since I was born. One was when I was in Paediatrics and I moved over to Adult Care at nineteen and I’ve been in that clinic for four years now. And I could go once a month, so you know and it’s quite, it’s quite a regular kind of contact with them. So I suppose you do, you have to trust them because they are making medical decisions on behalf of you sometimes. Obviously you have a say but I suppose you do put your trust in someone medical sometimes because you, well you have to.  

Kay really wanted to improve her lung function and was pleased to be invited to take part in a...

I was having quite a bad period of health I think. My lung function had gone down quite a lot and I think, although my lung function had gone down it was still in the relevant kind of ranges to be on a clinical trial, that this particular clinical trial of Mannitol. So I basically wanted to do anything I could to try and get my lung and help and I was invited by, we’ve got a research nurse at my hospital where they we have CF care, and she leads all the clinical trials and the consultant there he liaises with the research nurse to get all the ethics approved etcetera. And I think they just approach patients that they feel would be happy to be involved with the clinical trial or fit the medical criteria. Because obviously there might be loads of people that want to take part in the trial but if they don’t fit the medical criteria they can’t get involved. And I think because I’m quite a compliant patient as well I think they knew that they I could they could rely on me to kind of take the medication every day and record if I had, you know, any side effects [noise] or anything like that which, I think they could rely on me which is quite a big thing if you want to get good data so. 

Having the opportunity to contribute to medical research and help to prolong the lives of people...

What’s your experience been across all three of taking part?

 

Quite positive. It’s quite nice to know that I’m, although I do think of it selfishly sometimes I do want my lung function to improve or I want to have the best quality of life. I do think of it, it’s quite a good thing for other individuals for that are growing up, you know, this might be the future, I might be trialling the future treatments of those that are growing up with problems. So I think it’s quite nice to be involved in something that might benefit other people with CF when they’re older. So my feedback is really positive about the clinical trials just because I’m benefitting from it, others can benefit from it, I’m getting paid for some of them and I’m helping out my CF Team, so I’m generally quite happy. Yeah.

 

Lots of different reasons for taking part and thinking about the motivation to take part, going in, and you know the real why am I doing this? Why am I taking this drug that I don’t know?

 

I think, there are, I think when you’ve had such a, I take many medications a day. And I think if you want to, I’ve done everything in my power to try and make my health as good as it can be and I do, I strive to have the best health I can and I do everything in my power. And if I think that maybe a drug could help that then I’m willing to try it. And yeah, there might be side effects, but you can get side effects from lots of different things, you can face them in the environment. So I don’t think it would be publicised by my CF Team and doctors if they thought it would really be a negative kind of experience, they’re trying to prolong people’s lives and I think medical research is the, is the way forward and if I can help with that then I’m quite happy to do that. I don’t know like, both the Heparin and the Mannitol have improved my lung function and I can’t be more thankful really.

 

And it’s nice that I’m in the position that I can do that because my lung function is kind of stable whereas other people haven’t got that opportunity. Some people aren’t as well as me and they don’t have that opportunity to try these medications out soit’s quite its quite nice.

 

Does it make you feel important, not important that’s the wrong word, but you know like you say you’ve got that opportunity?

 

Yeah, I think if you’re offered something that’s possibly going to be beneficial then I think it is important to grab it with both hands. Because it’s good and it means that if there are new medications that are coming for the other CF patients, they might consider me if I’ve been quite compliant with clinical trials that have happened before so, no I think it’s good.

 

It can be scary not knowing which drug you are taking, but it is a chance Kay wanted to take if...

At the start of the Mannitol study it was kind of double blind exercise so the doctor didn’t know if I was on Mannitol or it was a placebo and I didn’t know.

 

And did it, what, you’ve explained about it being double blind and placebo can you tell me a little bit more about that and - because you didn’t know at the time?

 

No, to begin with they said, I think it’s one in four chances that it could not be the Mannitol drug. So one of them, so I think three would be the Mannitol, but they’d be different strengths and the one would be a placebo so it would be, it wouldn’t have any kind of clinical effect. So they said, you know, there is a possibility that you might not be on the drug but if you feel worse or you feel like you want to drop out at any time during the study, you’re more than, you know, you can. So I think if I felt that I was getting any worse I would have probably thought that I was, I was on the placebo, and I probably would have dropped out to be honest. But it’s quite a scary thing to think you’re trying something that you think is going to help but it might be a placebo but I suppose you need to take that risk sometimes if it’s going to improve your health.

 

So that’s what I was wondering, because, if you don’t know what you’re having, at what point do you think, or was there a point because you were feeling better so you kind of in your mind think “Oh I must be on....” Did they actually inform you at any stage?

 

I’m free to ask, it was I think it was after the twelve months you can find out and I think the nurse did tell me that I was on it as soon as I asked really. The information’s available after the twelve months I think or it might be the sixth month, but yeah, you were able to get the information after you’ve completed a certain phase.

 

Kay doesn't think that she was on the placebo because of the way she reacted.

The way I reacted to the to the drug that I was in inhaling, because the Mannitol was actually in a little capsule like you pierced and then you breathed in. And the way I reacted to the to the drug or the placebo of Mannitol, I thought I was on some kind of drug because it really helped me bring up the mucus on my lungs.

 

Do you think if you’d been in the placebo, if you’d have found out you’d have been in the placebo group would you have been disappointed or? I mean the fact that you knew...

 

I don’t know

 

...the fact that you knew that you were in it, you kept going, but if you kind of thought...

 

I don’t know.

 

..it’s a bit you know like a hypothetical question because it didn’t happen but...?

 

Yeah, well I think the doctor said, “Even if you’re on the placebo you, because it’s such, because it’s an inhaled drug it has some kind of effect on your lungs anyway, so it might not be the Mannitol, but it might cause some kind of, not allergic reaction but reaction for you to cough so you probably would cough up something anyway”. So, although it was a placebo and it wasn’t Mannitol you’d probably get some kind of reaction anyway.So, the way I acted towards it, I think I was on Mannitol but I could possibly have been on the placebo. But because I reacted so well anyway I don’t know my lung function went up, that was what I wanted really.

 

Taking the trial drug was ‘fantastic' as it saved Kay so much time compared to her usual...

And it all, it goes hand in hand with the physiotherapy that I do day in day out. I do physiotherapy twice a day, so it’s just part of my routine now. And the reason, one reason that I liked the Mannitol was because it was quick and easy to do. I did it in the morning and in the evening. It was ten capsules, like I had to inhale in the morning and the evening. But it took about two minutes to do it in comparison to other treatments that would take fifteen to twenty five minutes. And obviously if I’m getting ready for work or I’m getting up, getting ready to go out that’s quite, that’s quite a big difference in the morning you know if I getting ready to go out in the night. So that was something I liked.

Did you enjoy taking part, you say it wasn’t very demanding on your time, I mean how did it fit in with your?

 

Fantastic. It was the best experience because I’d been spending, because in place of another, the Mannitol took over the place of another medication. So the other medication would take me twenty five minutes to do each time and I was meant to do that twice a day. And it only took me two minutes to do the Mannitol. And it’s quick, it’s easy to take away, it’s efficient. Its, I couldn’t speak highly enough of it, it was really really good. And it tasted, because it’s an inhaled drug it tasted much more pleasant than the other drug, the other drug. So I was happy all round.

 

The doctors and nurses did their best to ensure any extra appointments fitted in with Kay's...

It was all in nicely set out. I had boxes of medication and I’d set up regular appointments with the CF research nurse. And she could we just; she’d keep me informed all the time. She’d either give me a phone call every week to see if I was getting on okay with it. And yeah, everything was well set out and is all in, in a diary and all in a diary that we could write down notes and things and we always had regular appointments anyway so she’d.

 

So what was involved? you know in terms of what they were testing you had to take it, did you have regular appointments, did you have to go in or did you just keep a diary. I mean what was actually involved in doing the trial?

 

Taking the medication twice a day. Any side effects record it. And then the regular appointments they actually fitted it in when I needed a clinic appointment. So it meant that I didn’t have to go to the hospital all the time I’d be going just as much as I normally would be going but they’d fit in the study appointment, my clinic appointment, everything else so if I needed blood tests they’d do it all at the same time. So it didn’t really put much extra stress on me because it was just a normal clinic appointment but they just tested my lung function every time I went in and they did different sputum samples and things like that. So I think the, with, because you are helping them out with the clinical trial they kind of bent over backwards to make it as easy for you as possible so they fitted in your clinic appointments and your study appointments at the same time which is obviously quite good.

 

Kay knew what the side effects might be and what to do if she experienced any, but in fact she...

Is it nicer than the Mannitol?

 

It’s nicer in a way that I don’t have to take as many capsules. But if I was given a choice between, I don’t know actually I like both of the medications, I probably would go for the Heparin just because it’s only got four capsules whereas the other one’s got ten capsules and I didn’t mind ten capsules but I can imagine some people thinking that’s quite a lot to do in one, in one go.

 

But no, but what I thinks’ really good I get paid £70.00 for each time that I go to the study which I’m benefitting from the medication anyway. They put my clinic appointments in with my study appointments. So I don’t have to go to the hospital any more than I would be and I obviously get paid and it’s helping my chest like it’s really really good so.

 

So it’s beneficial?

 

Beneficial in a lot of ways so

 

Yeah.

 

I’m happy to be to be on it.

 

And this is just a straight, the other one was like a double blind trial, this one’s a straight forward?

 

No. It’s the same. You’ve got placebo and three other different strengths so it’s the same sort of chances of the Mannitol. But the way I’ve reacted to this medication I think I’m on some level of Heparin , I don’t know what dosage, but the way I’ve reacted I think I am.

 

Kay is hoping that if the trial drug proves to be of benefit, then she will be able to continue...

But you’ve still got the opportunity of going on to the Mannitol; you having you’re not going to be completely left with, going back onto old medication?

 

No the doctor said that if I like the Mannitol he’ll fight my corner to get it so the NHS will pay up for it so, he’s, the good thing about my CF (Cystic fibrosis) Team is that they’re really kind of patient focused and they, they’ll do anything they can for their patients so.

 

So it’s not a given, he’s still got to ask for it?

 

It’s if I want, they’ve said “If you think it’s that valuable then you can have it”. Because I think you know the NHS has changed now, it’s not the doctor just prescribing; it’s kind of patient/clinician making decisions together so. I think if I ask for it he’ll fight for my corner for it which is, which is nice.

 

Kay would like to know the results of the trial, but it may take a while to hear. Trials may show...

And what will happen at the end?

 

At the end I assume, they usually provide some kind of information on how the results have affected everyone else or how, how the medication has affected everyone else in the study. So that probably won’t be available for a while. But, I assume eventually they’ll provide some kind of feedback and go from there.

 

I mean in both those other trials, the Mannitol and Heparin, have they said when you might get the results and when the study completes, when it finishes?

 

I think the Mannitol has actually finished and they have provided some kind of verbal feedback. But I think there’s, they’re waiting, they wanted the Mannitol to become kind of okay for the NHS to prescribe, I think they’ve got quite a lot of people and things to do. But I think that’s going to be available via the NHS eventually for people with respiratory problems. But no I think if I ask for the information it would be readily available. I’m not sure about the Heparin because it’s at such an early stage I think.

 

I just wondered whether it was in the information that they actually gave you a time scale and whether they’d give you any of the results at some point when the study ends?

 

They do, they do say that they can provide kind of facts and figures at the end but if, I suppose if you ask for it really.

 

Yeah. Do you think that’s important to know?

 

I think it is, but on a really selfish level as long as I’ve reacted quite well to it then I’m quite happy. And I think, I think with all the new CF drugs coming through all, any kind of new drugs coming through at the moment and it’s all about tailoring the, tailoring the drugs to the certain individual. So, as long as it’s beneficial for one person, okay it might not be beneficial for another twenty, for the other twenty people, but if it’s beneficial for that one person then I think it’s a good thing. So I suppose it is interesting to know if it’s beneficial for a wider range of people but if it’s, if it’s helpful for a minority then it’s still, it’s still a good thing because everyone, you know, some people can have a headache and paracetamol won’t touch it but you know paracetamol can be helpful for other people so . I think its trial and error with medicine as well.

 

Kay advises to get as much information as possible about a trial before taking a decision to take...

Just get as much information as you can. Reasons, pros and cons for getting involved, how is it going to benefit you, will you get reimbursed for travel expenses, can you can you drop out at any point. You know what are the side effects? If you know if you do get these side effects can they treated quite easily. Yeah, just get as much information as you can just be fully informed of the drug, well it depends what item if it’s a medication just get as much information as you can about it, on duration of it, just yeah just be fully informed, fully informed on everything.

 

Kay was pleased to have the opportunity to take part in two drug trials and would consider future...

I think if you’re offered something that’s possibly going to be beneficial then I think it is important to grab it with both hands. Because it’s good and it means that if there are new medications that are coming for the other CF [cystic fibrosis] patients, they might consider me if I’ve been quite compliant with clinical trials that have happened before so, no I think it’s good.

 

I assuming from that that if they ask you to take part in another one you would?

 

Possibly. My work commitments and social commitments are getting quite a lot at the moment but if I do have the time I think that’s another thing, I have, I have got time at the moment so that’s another reason why I’m quite happy to help out. But work schedules get quite busy so we’ll see.

 

So it might depend on how, what the involvement is?

 

Yeah, yeah.

 

And the level of the involvement?

 

Yeah. Yeah I think yeah I’ve got quite a lot of like with this job it means that I can do, I am like allowed to take time out for appointments and things whereas you know if I do get another job I might not have the opportunity to do that, so.