Katie - Interview 54

Age at interview: 13

Brief Outline: Katie is taking part in a randomised placebo controlled drug trial. She was keen to take part, and feels special as there are only a few young people taking part in the UK. However, due to her health Katie has had to stop the trial for a short while.

Background: Katie is 13 years of age, is White British, attends a local school and lives with her parents and sister at home. Katie was diagnosed with cystic fibrosis when she was 2 days old.

More about me...

Katie is 13 years of age, attends a local school and lives with her parents and sister at home. She was diagnosed with cystic fibrosis at birth that affects her digestive system and lungs. Her mum responded to an advert in a journal about a trial that was taking place and asking for recruits. Katie’s mum rang the number provided and found out more about the trial and whether Katie would be eligible to take part. The trial was to test a new medicine that would be of benefit to Katie’s’ particular type of cystic fibrosis. She says that the new medicine is supposed to help reduce mucous in the lungs so you don’t get as ‘blocked up’ and help make you feel better too.

Katie and her mum went to the hospital and she remembers the nurses explaining everything to her and reassured her that she could stop the trial at any time. She was also told about possible side effects that included a rash. She says it was good to be informed about side effects so if she did get any of them you knew it was the drug and nothing else. Katie had some tests at the hospital to make sure she was eligible to take part. This is sometimes called ‘inclusion criteria’ or ‘eligibility criteria’. The tests included checks on her lungs such as a lung clearance index and lung function. She was pleased that she was able to take part.

She says that the trial is a randomised placebo controlled trial which means she may be allocated to receive the drug or the placebo. The trial is also double blind so neither the doctors and health professionals involved in her care nor Katie knew which group she was in. She says that she is glad she doesn’t know because then it is a ‘surprise’. She says that if she knew what medicine she was taking she may have tried harder and said things to make it sound like she was better, so not knowing is a good thing.

Katie has to go every two weeks for tests on her lungs, blood tests, and also completes a short questionnaire about her health and how she is doing. The tests don’t take too long, about two hours, and the trial is for about four months. She says that everyone at the hospital has been really nice and she enjoys going for her checks and being part of the trial.

However, Katie as been poorly and has had to stop the trial. The research team said that she can come back in the trial when her health improves. She will have to have some tests again to ensure she meets the criteria. She is hoping that she can rejoin the trial when she is better. She also gets paid for taking part. She has been paid half and receives the second half of the payment at the end of the trial, so she admits that this is a bit of an incentive for wanting to rejoin.
 

Katie and her mum responded to an advert in a science magazine. They emailed the researchers and made an appointment to speak to them about taking part.

So do you want to tell me how that came about and what happened?

 

I don’t know exactly but I think what happened was that my mum was finding out about it and my granddad sent mum an e-mail with the link to this news, this news finders magazine and it had about the trial in it. It was just ringing them up and finding out about it and that’s how I got on the trial.

 

So did your mum sort of enquire?

 

Yes.

 

Did she speak to you about it at the time?

 

Yes.

 

Yes.

 

Because she showed me the e-mail and the magazine.

 

So what kind of things did it say, what was it saying?

 

It was just saying that there’s this new medicine that’s going to help this type of medical condition because the medicine only helps with my particular type of CF which is G551D I think it’s called.

 

It’s got a number?

 

Yes I think it’s that.

 

Yes. And so were they, was it like an advertisement in a like in a magazine?

 

No it was an article about it.

 

Did you have, do you have to go, in the beginning when you first went you had an appointment with the consultant there, yes and was that the same consultant you see at the hospital where you were, no?

 

It’s a new consultant at the hospital there.

 

So it was a new consultant you haven’t met before?

 

I think it was a consultant.

 

Right yes okay. And he, did he explain?

 

She.

 

She explained things to you.

 

Yes.

 

And what sort of things did she tell you can you remember?

 

Just like explaining how I could drop out at anytime if I didn’t want to do it anymore if I was feeling, you know I could just finish any of the tests. So I could just, if I didn’t like any of the tests I could just drop out for a bit and then have another go at the test.

 

Was that reassuring for you, yes? And did they explain about any side effects to you at the time?

 

Yes they said one of them might be a bit of a rash and they said a couple of other ones. So it was quite reassuring knowing that if I was going to get something then I would know it was that, it wasn’t something else.

 

Okay so it was good to know that, the side effects, do you think it’s important that they told you about that.

 

Yes.

 

And did you have any questions at all?

 

I think they pretty much summed it all up in the information.

 

Was you quite concerned about anything at all?

 

No not really.

 

Did you then have to sign a form to say yes we agree to take part?

 

Yes once we knew I’d met, I’d matched the criteria we had to sign a form if I wanted to take part in it. And they just gave me an idea of what tests I’d have to do.

 

Katie took part in a phase 3 trial because she wants to see the new treatment approved in the UK and Europe for people with less severe illness.

What were your key reasons for taking, wanting to take part?

Because I make sure the medicine, because it’s only approved in America at the moment, so we’re trying to get it approved in this country and Europe. So in the UK and Europe we’re trying to get it approved so people can get it, but because it’s for people that aren’t very well as well I think at the moment but we’re just saying what’s the point of getting it you have to wait to get ill first so we’re just trying to get it through for that because it’s well people they’re testing it on now. Because it’s in the third phase, the trial.
 

Katie's health had to be stable and her lung function and lung clearance index had to be in a certain range before being eligible to take part in the trial.

So then what happened when you went to the hospital did your mum ring the hospital to see if you could take part in the trial?

 

Yes then we went up for the test but then I was on a medicine and I had to be on a stable thing, I was only on the medicine for two weeks, so I had to be on a stable medicines for like a month, so we had to wait for a month and go back again. Then we had another burst, trial thing and then I got on because my liver function was back where it needed to be for the trial.

 

Okay, so you had to meet a certain criteria?

 

Yes. Because you had to, because your LCI; lung clearance index had to be in this range and lung function had to be in another range so.

 

And what was the criteria, do you know?

 

I think it was between 90 and 100% for lung function, the LCI, can’t remember what it was; I remember only just getting the lung function by 1%, because I got 91.

 

Wow, yes right, so you met all that and did that, did the tests take, did you have them all done on the same day or did you have to keep coming back?

 

Yes I had the same tests each time but I didn’t have the same amount on my first visit, so just had lung function and LCI to see if I matched the criteria, that’s all I had.

 

Okay and how long did that sort of process take before you could take part in the trial?

 

It took about an hour and a half, two hours because of all the talk and explaining.

 

Yes. And then, so on that day sort of did you agree on the same day, yes and you were happy and your mum?

 

Yes, it was worth it though going up there and it wasn’t, it isn’t a wasted day either because you only spend an hour and a half, two hours at the hospital you can just go, because like seeing the place where it is and everything afterwards, so that’s nice.

 

Because of an infection, Katie was advised to stop the trial. She didn't want to, but knew it was for the best and may be able to rejoin the trial when she is better.

Did you have to stop the trial at all?

 

I had to stop the trial for a bit because the IV’s interfere with how well I am.

 

Okay, what’s the IV, do you want to explain?

 

It’s intravenous which is basically where they put a tube into your vein and the medicine goes straight into your veins instead of having to digest it all. So it goes straight into your system and its stuff that can’t be taken orally.

 

So did you have to stop, you had to stop all the other, the trial?

 

The trial medicine, yes. Because I was on wash out month and I just went downhill a bit, I don’t know, I think it’s because of the summer all the tree spores and hay fever and everything.

 

Oh yes, you think that, do you normally get that?

 

Yes it’s usually in the summer.

 

Is it?

 

And worse.

 

So that, did that bother you at all?

 

A bit but I can go back on it.

 

What did they say at the hospital when that happened?

 

Which hospital, the trial?

 

The trial hospital yes.

 

They just said that you can go on IV’s and you have to be clear of everything for six weeks and then you can come back. But now I’ve got to have a camera in my lungs, I’ve forgotten what it’s called.

 

Bronchoscopy is it?

 

Yes I’ve got to have that. It’s either at the end of this week or the beginning of next week. So that’s and then I have to go on IVs straight after so that’s been put back again and IV’s every six months.

 

Yes, but have they said that you can stay in the trial?

 

We’re just going to see how it goes.

 

Right okay, so at the moment you’ve had to come off the trial?

 

For a bit.

 

For a bit yes, how do you feel about that?

 

I feel alright, I‘ve just got used to being off the trial for a bit now. So we’re just going to see how it goes and see if there’s any point going back on it. I probably will but we don’t know yet.

 

And what have they said at the trial hospital, did they say?

 

They said that if there’s a clinic, a clinical problem just stop the trial, get better and in six weeks being clear of everything.

 

And then you can re start?

 

Yes do the same thing.

 

Does that kind of, does that feel good that you can?

 

Yes it feels nice like I can restart it at some point.

 

And will you do you think, do you think you will if things are okay?

 

Yes if I can I will, definitely.

 

Katie was pleased not to know which drug she was taking, she may have tried harder to be better if she did.

And did they use words like randomisation and placebo and?

 

Yes because one of the medicines was a placebo and one of them was the actual medicine.

 

Okay. And what does placebo mean to you?

 

It means it’s not an actual medicine it’s just a dummy or something.

 

Were you randomised into a group, did they say you’d be randomised?

 

Yes.

 

How would you explain that to somebody?

 

That you don’t know which one you’re going to get first and which one you’re going to get second.

 

Right and were you okay with that?

 

Yes.

 

Yes, how did it feel like to be sort of not know whether you were going to get the actual or?

 

It was everything like you just want to know but in other ways you don’t. You want it to be a secret or a surprise.

 

Why is that?

 

It’s just because it’s nice to not know sometimes because you don’t want to know you’re just taking something that isn’t the actual medicine and yes.

 

Do you think if you’d have known, then if you were taking the placebo perhaps you might have...?

 

Yes, because I would have tried harder to be better probably. Or said stuff that make it sound like I was better. Even though I knew I was on the medicine.

 

Katie said that everyone was really nice at the hospital and seeing the same doctors and nurses was really nice too.

I was thinking that because I haven’t finished the trial yet but so far I’m thinking the people are really nice there and it’s the same people each time so that’s quite nice because there isn’t different people.

 

Is that when you go to the hospital is it?

 

One of the course,I had to have lots of tests done like quite a few each time but other than that, it’s good.

 

So you’ve enjoyed it being part of something?

 

Yes.

 

Katie had to attend the hospital every two weeks for tests and complete a short two page questionnaire, but because the tests were similar to those as part of her routine care, she knew what to do.

They said that we were going to have to come up every two weeks and we went to the same place in the hospital each time so knew everyone there and I came in, they spoke to us, we did that survey, we did some tests and at the end of the first one they gave me like one of the medicines, like the medicine or the placebo, they gave me a packet so.

 

So then you started?

 

Yes they gave me enough for two weeks, so I got another dose when I went back again.

 

So did you have to go back for every two weeks did you?

 

Yes, every time they did tests I, it was good because I knew what they were going to do and I knew how to do the tests after the first time.

 

Oh so what were they, what were the tests?

 

There was they put these electric to test sweat levels I think to get sweat out and they were testing it. Lung Clearance Index or LCI where you have to breathe on this tracer gas to see how fast you can get it out of your lungs to see.

 

So is that blowing into something?

 

No you breathe in tracer gas. And then...

 

What does that mean?

 

It’s just so you can trace it on a computer screen. Then they take the gas away and just breathe normal air into the tube and then they can see how fast you can get the tracer out of your lungs to see how fast you can get air out of your lungs.

 

Oh I see that comes up on a computer does it?

 

Yes.

 

Do you see that happening?

 

No because people try and get it out quicker if they can see, because it varies results and you can see it on the screen, they explain it.

 

So you’re not allowed to see how you’re doing?

 

No.

 

Do they tell you afterwards?

 

Yes they say I did quite well but I think that’s just because I’m used to everything like that, like nebulisers and everything. And I had to do lung function which is where you blow into a machine and one of the things that they look at FUB1 which is how much force of air you blow out in the first second and FUC which I think is how much you can blow out or how long it takes you.

 

Oh okay, so it’s quite a few little things to do then.

 

I do that in my normal hospital when I go to clinic. So I knew how to do that.

 

Katie knew she was going to receive a payment on completion of the trial and although she was keen to take part because of helping to improve her health and other people, the money was a bit of an incentive too.

Have they sort of mentioned any payment to you at all for taking part?

 

Yes.

 

Do you want to tell me what that was?

 

£480.

 

Is it, is that on completion?

 

Yes, I’ve got half of it and some of that’s going towards the summer camp thing, it’s at [name of place] I’m doing the summer camp there. Where it’s just skateboarding and mountain boarding. Climbing they’ve got a big climbing wall.

 

But they’ve said you’ll get the other half if you complete then?

 

I think so.

 

Has that been the motivation for you, you wanting to take part?

 

Yes I’m planning to buy a laptop or a new surf board or something.

 

Okay, so you’re quite keen to continue?

 

Yes.

 

Do you think it’s important that you know you have that offer of payment?

 

Yes because like not many people, not, some people would just be like yes we’ll just do it for a volunteer but yes it’s good.

 

Was it, when you, when you went and, did they explain that in the information that there’d be a payment?

 

Yes.

 

Did that, did that, be honest now, was that like a bit of a motivation?

 

Yes.

 

Was it?

 

A little bit. I did like the idea of doing the medicine and everything though.

 

Even though Katie did not really experience any side effects she was glad to know what they might be so if it happened she'd know why.

Was that reassuring for you, yes? And did they explain about any side effects to you at the time?

 

Yes they said one of them might be a bit of a rash and they said a couple of other ones. So it was quite reassuring knowing that if I was going to get something then I would know it was that, it wasn’t something else.

 

Okay so it was good to know that, the side effects, do you think it’s important that they told you about that.

 

Yes.

 

And did you have any questions at all?

 

I think they pretty much summed it all up in the information.

 

Was you quite concerned about anything at all?

 

No not really.

 

Even though everything is explained and you are given plenty of information, Alexander feels that...

Did you have to stop the trial at all?

 

I had to stop the trial for a bit because the IV’s interfere with how well I am.

 

Okay, what’s the IV, do you want to explain?

 

It’s intravenous which is basically where they put a tube into your vein and the medicine goes straight into your veins instead of having to digest it all. So it goes straight into your system and its stuff that can’t be taken orally.

 

So did you have to stop, you had to stop all the other, the trial?

 

The trial medicine, yes. Because I was on wash out month and I just went downhill a bit, I don’t know, I think it’s because of the summer all the tree spores and hay fever and everything.

 

Oh yes, you think that, do you normally get that?

 

Yes it’s usually in the summer.

 

Is it?

 

And worse.

 

So that, did that bother you at all?

 

A bit but I can go back on it.

 

What did they say at the hospital when that happened?

 

They just said that you can go on IV’s and you have to be clear of everything for six weeks and then you can come back. But now I’ve got to have a camera in my lungs, I’ve forgotten what it’s called.

 

Bronchoscopy is it?

 

Yes I’ve got to have that. It’s either at the end of this week or the beginning of next week. So that’s and then I have to go on IVs straight after so that’s been put back again and IV’s every six months.

 

Yes, but have they said that you can stay in the trial?

 

We’re just going to see how it goes.

 

Right okay, so at the moment you’ve had to come off the trial?

 

For a bit.

 

For a bit yes, how do you feel about that?

 

I feel alright, I‘ve just got used to being off the trial for a bit now. So we’re just going to see how it goes and see if there’s any point going back on it. I probably will but we don’t know yet.

 

And what have they said at the trial hospital, did they say?

 

They said that if there’s a clinic, a clinical problem just stop the trial, get better and in six weeks being clear of everything.

 

And then you can re start?

 

Yes do the same thing.

 

Does that kind of, does that feel good that you can?

 

Yes it feels nice like I can restart it at some point.

 

And will you do you think, do you think you will if things are okay?

 

Yes if I can I will, definitely.