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Clinical trials & medical research (young people)

What is involved in a trial: appointments and monitoring

When you take part in a clinical trial it usually involves one or more visits to a hospital clinic, GP surgery or research unit. Sometimes an overnight or longer inpatient stay may be needed. How often you need to go and how long each appointment lasts depends very much on the type of trial and the intervention being tested. Visits may be either to get the treatment or intervention, or to be monitored to see whether the treatment is working and to check your health. Before the trial begins there may also be visits and tests to check that you are able to take part. (See also ‘What is involved in a trial: time commitment, costs and payment’.)
 
Healthy volunteers, for example in vaccine trials, often need very little involvement and sometimes the appointments are at the weekend which may make it more convenient for young people and their parents. On some occasions the researchers came to the participants' homes to take blood samples and give the vaccine injections, as was the case for Buddy below. 
 

The researchers went to Buddy’s home to take some blood and give his Menigitis C vaccine; it didn...

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Age at interview: 13
Sex: Male
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It wasn’t really too bad. Because she came and talked to me about like what she was doing and it didn’t hurt.
 
Did she have to; did she explain what it was all about?
 
Yes.
 
It was just like, was it just one vaccination?
 
I had one vaccination and they took some blood.

 

Most young people we talked to said that appointments were made at convenient times, or at the same time as their regular clinic visits, and some were able to change appointments to times outside school hours. One or two young people quite enjoyed missing time off school. (See ‘What is involved in a trial: time commitment, costs and payment’.) 
 
Young people we interviewed said how nice all the staff were and how nice it was to see the same doctors and nurses.
 

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

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Age at interview: 13
Sex: Female
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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.

 

 

Being in a trial was a new experience for Joe, but all the staff were really nice and helpful.

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Age at interview: 15
Sex: Male
Age at diagnosis: 15
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And when I first went in I didn’t know anyone in there and I was really worried because I knew something was wrong when I got diagnosed. And, but, yes, the doctors were really nice and the nurses and stuff. And I mean I think when I was in there I trusted them, when, when I was on the trial I trusted them because they just like, they were really nice to me and they helped me and stuff. And I trust them now obviously and, yes, I think they’re really nice.

Some trials may involve treatments that can be taken at home, such as tablets or self-administered injections. This could make life much easier, although Joanna (below) pointed out that you do have to be quite well organised.
 

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

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Age at interview: 23
Sex: Female
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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.

 

 

Taking the extra medication with her regular tablets was easy for Ruby and she only attends...

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Age at interview: 17
Sex: Female
Age at diagnosis: 16
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When I agreed to take part, the doctors, like they randomised me to one drug. And then I went to get it from the pharmacy. And then I have to take that every day. And then if I run out I’ve got to go back to the pharmacy and get more.
 
So when you say, how do you have to take the drug?
 
I was randomised to drops of something, and I’ve got to take seven drops a day. And they have to be kept in the fridge as well.
 
Well, the drops have to be kept in the fridge. And then I have to take seven drops every day. “It doesn’t matter when” the lady said, “Just take it.” And then if I run out I’ve got to go back to the pharmacy in the hospital to get, but usually I’m there anyways for an appointment, so I get it when I’m there.
 
And how, how long do they normally last- the drops?
 
They last maybe like three months quite well, because it’s drops. So they give me like a few tubes there every time I go.
 
So you go when you said you, when do you have your sort of regular appointments?
 
Every time I go they book me in for another one in the, in like the next two or three months.

I think it would have been a bigger thing if I hadn’t been diagnosed and hadn’t been having to take other drugs at the same time. Probably because it’s at the same time it’s been more like mixed up together. So when I go for like, when I go for my appointments at the hospital it’s all like mixed together. So it’s not like separated into two different things. So, yes, so, yes, it seems like less because it’s taking up less.

 

 

It sounds easy to take an extra tablet once a week but on occasion Joanna did forget, but because...

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Age at interview: 17
Sex: Female
Age at diagnosis: 16
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What does the trial involve for you? What do you have to do?
 
Yes, I have to take a tablet once a week and then calcium every night. Which is quite, it’s harder to remember taking it once a week instead of every day, because that’s just routine. But once a week is quite difficult to remember. And then the calcium to take every night. Because it’s not very nice to take them if you haven’t got juice in the house or something. It doesn’t taste nice.
 
Does it come as a liquid then?
 
No, it’s in a sachet and you’ve got to put it and mix it in your drink. And it’s not very nice to take either.
 
Is that off-putting?
 
Yes, it’s not very nice to drink. So you’ve just got to drink it quickly.
 
Drink it quickly, yes. What does it taste of?
 
It makes the juice fizzy. And then it’s got a bit of a weird taste to it that, I can’t really describe the taste. But it just tastes like juice but a bit weird.
 
Not pleasant.
 
No.
 
And what happens, does it matter, you know, like you say you forgot sometimes, was it okay to take it the next day? Or did you have to let them know that you’d forgotten?
 
No, it was okay to take it. I think, on the leaflet it said, “Just take it as soon as you remember.”
 
Did you, did you own up to them some- and tell them that you’d forgotten sometimes?
 
Yes, I did actually. She asked me if I had and I was like, “I’ve missed a few weeks.” Just because I’m sometimes really ill and I, like just before my birthday I was in hospital. And they think that I may have bowel disease now. But, so I’d have to leave, I’d, because I went in A and E I’d forget the, to take that in with me. And my mum wouldn’t have a clue where to find my, so it would just be quite complicated, yes. So there’d just be times where I’d be too ill and forget about it. Or there’s other things as well, like my, because I’m, in college I do shows and everything.
 
Acting?
 
Yes, musical theatre.
 
Oh, lovely.
 
Yes.
I’d like to talk about that as well. I don’t think we can. I just wondered what was the longest you missed then? How, you know, was it like just one you forgot to take it the one night? Or was it like did you miss a whole week at some point?
 
I think I missed a couple of weeks at one point.
 
Did you
 
Yes. Because it was just so complicated. Because if I took the tablet I’d have to sit up. And it would be too late of a night to take it by then because I’d just want to go to sleep because I had college in the morning.

 

Occasionally young people said they had to take their medication on holiday.
 

Taking the injections away on holiday was worrying for Courtney; she was worried that the fridge...

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Age at interview: 12
Sex: Female
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Was that the injection? Okay. You didn’t want to have the injections?
 
But it didn’t, it did hurt, but not that much. But it did hurt at first but when I got used to it, but and then, and then I didn’t really like it when people were around I had to have it round like keep people [looks to Mum], didn’t I Mum?
 
It’s okay.
 
And...
 
It’s hard to remember it all isn’t it?
 
And then I had to take it on holiday and that and I didn’t want to. So that’s,
 
Why didn’t you want to?
 
Because, oh I don’t know. Because I didn’t want it, I didn’t want to take it on holiday because just in case like the fridge weren’t working.
 
Oh in case, was that because they had to be kept in the fridge to be cold, and you were worried that they weren’t, wouldn’t be kept cold?
 
Mm.
 
Did Mum have to check there was always a fridge?
 
Yeah.
 
When you went away?
 
All the time.

 

Some young people took part in trials to help find the best approaches to help young people manage their health. These types of trials varied from one day interventions, staying in hospital, to completing questionnaires at the clinic or at home. Sophie, aged 12, was diagnosed with Type 1 diabetes when she was three. She recently took part in a randomised trial to assess the value of an intervention for use by clinicians to help young people manage diabetes and other long-term health conditions. 
 

Attending a one day group intervention was a great experience for Sophie. She enjoyed being with...

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Age at interview: 12
Sex: Female
Age at diagnosis: 3
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So were there any different age groups?
 
There were, I know there was me, I was in the 11. There was, I think we were 11 to 16, 18.
 
And were there many in the group?
 
I think there was like eight of us. Something like that.
 
Did you; did you like being in a group like that? Would you have liked it to have been more one-to-one?
 
No, I think it was quite, quite amusing.
 
In what way?
 
Like everyone would be, when like, it wouldn’t be like when, when you take your, when you take your needles well, needles, when, when, when you take, well, I went on a pump then, because I’ve got a pump. When like everyone took their needles it would be all together instead of like you’re doing it on your own, not like in school.
 
There was like loads of like, like other people there like what, like I said, like it varied between like ten or fifteen of us. And like they used, they, they, they had this big board. What we like, we had to like, jotted down things. So like, like how to like get, like calm yourself down when you get stressed. And then we went on to like how, how do we feel like being in school with our diabetes and everything. Oh, it weren’t just diabetes; it was asthma and…
 
So there, were there children, did all the children have diabetes?
 
Not all of us, not all of us. There was asthma,Did they split you into little groups?
 
Yes, there was groups of three.
 
Oh, I see. And did you all have to sit round together in a, in a group with a, was there a nurse for each group?
 
Like a, a, not so much a teacher but like this person with some, that condition itself. Because there was a teacher with diabetes, there was a t-, teacher with asthma and there was a, there was a teacher with epilepsy and there was a teacher with… ADHD. And they all took us off like into separate groups.
 
And were you all in the same room?
 
Yes, just different parts of the room, yes.
 
Was it a big room?
 
Yes.
 
Good job, wasn’t it? Lot of chatter. That’s a good way of doing it.
<
 

Meeting other young people with diabetes and sharing experiences was really beneficial to Sophie....

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Age at interview: 12
Sex: Female
Age at diagnosis: 3
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And what was the questionnaire that you filled in? What was that about?
 
It was like about like how do we feel about our condition. How old we are. And like the contact numbers and signatures and all that. And like as you go through it we had to like tick like things about like s-, how do we feel about something like our diabetes for instance. And like, there was like, three columns. Okay with it, good, very good. And that’s it, like there were circles and we had to tick each one.
 
And did you find that easy to complete? There weren’t, were there any questions that you had about that, filling in that questionnaire?
 
Yes.
 
What sort of questions did you have about that?
 
Like were we nervous like coming to the thing to fill in like a load of things, things what, like nervous when we were coming because we’d never met other children before like us? And like are, are we, like are you stressed or confused about like anything about like your condition?
 
And is that things that they asked you? Was that on the questionnaire, was it? And how did you respond to those things?
 
I said sometimes confused with it because like there’s a lot to it. Like you’ve got to like take your blood sugars if you, and like you’ve got to work out whether you’re low, you’re high or you’re fine.
 
Were there other questions at all?
 
There was like things about like how do we cope with like little brothers and sisters wandering around and getting hold of things? I said that we have it all stored in a, because I, we, I have it stored in the kitchen. Because we’ve got like high cupboards off the, on to the, like the ceiling we keep them in, so my little sister and brother can’t get them.
 
So there was advice about safety and, and hygiene, things like that?
 
And then like there was a big board, like a stand-up, there was like a stand-up board like round about that big. And there was like paper on it, and like every time we said something they’d write it down and see like, how we, like is it positive or n-, negative things. And then we did like, we did a game and then we did, went, went back and d-, done some more like, questions, like things on the board. And then we went back and xx another game, had lunch, then we played a big game at the end.
 
So it was busy then? And they had a flip chart? What did they do with all that information on the, on the flip chart?
 
Well, they put, put it in to columns and like positive, negative or is it strong or weak. Weak as in like is it like not too good, and strong if it’s really good.
 
So what were the, what were the strong things? What sort of responses were those?
 
Like if you have stress, like they can keep you awake through the day, making sure like you don’t fall asleep. And then like the strong, another strong thing was like they can, they can remind you of things like in the past of what you did. And then like the weak, weak things, like it, it can keep you awake most of the night and you don’t get any sleep and then you, if it goes the next day you’ll be asleep in school or college or university. Because there was a group as well there which was in their 15 and 16s who have just left school, so they’re on, like just doing GCSEs at college and uni. So they was from there. And like another strong thi
In Sophie’s case above, the intervention was led by ‘adults’ and Sophie felt that this was good' “Because they’ve had more experience. They know more about it and they know what to do”. Sophie would like to take part in similar trials in the future. 
 
Joe was recently diagnosed with diabetes and took part in a randomised trial to assess hospital versus home management at diagnosis in childhood diabetes. This was his first clinical trial and he was allocated to stay in hospital for a few days.
 

This was Joe’s first clinical trial and he was pleased to be allocated to stay in hospital for a...

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Age at interview: 15
Sex: Male
Age at diagnosis: 15
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Joe' Well, when I got diagnosed they told me there was a trial and I could either have gone home and see how I dealt with it there or stay in hospital. And I got chosen to stay in hospital. I stayed in hospital for I think it was two, three days. And they showed me how to do my injections and do blood tests and stuff. So they were really helpful, the nurses and stuff.

As part of the trial it was about informing you about the diabetes and helping you, do you think it, the way they did it in the hospital, so I suppose some people may have had, just gone home with information, but you had information and hands-on. How did, you know, is that a good way, do you think that is the, sort of a good way, than being on your own?

Joe' Yes, I think it’s much better than being sent straight home because, well, I know that you might be more comfortable at home, but when, when you do have something like you’re not sure about, being in the hospital you can like instantly find the answer and they tell you what to do and how to do it and stuff. But at home you’d have to ring up and, you know, the problem might already be there before, before you’ve had a chance to ring up. So I think, and I felt more like I didn’t have to worry as much while I was in the hospital. Because I thought at home I’d have to worry about it more, and in the hospital they took care of me much more.

Mum' It felt safer, didn’t it?

Joe' Yes, safer, if, yes.

So a bit more reassured?

Joe' Reassured, yes.

Mum' And confident because you know you’ve got people there you can help you.

Joe' Yes. And I knew if something was to happen then I’d be fine because I was, I was in the hospital.

Mum' We didn’t like staying in, but it was the best place for, for him.

Joe' Yes, I mean I would have, I would have obviously liked to have been at home, because I don’t think anyone likes spending time in a hospital. But yes, I think it was much, much more like –

Mum' best thing, wasn’t it?

Joe' Yes, reassuring when I was in there.

Although they did let me, because I was dealing with it really well, and they said if, if you do go in, if you do get kept into hospital and you are dealing with it really well, then they, they let you go home in the daytime for dinner and stuff but you have to come back and sleep there. Which, that’s why; a good thing I can say is if you’re not worried and just deal with it, you know, they’ll let you go home for a bit.

So you weren’t kind of imprisoned or stuck there? There was a little bit of flexibility?

Joe' Yes.

So that, did that put you at ease a little bit?

Joe' Yes, it did, because then I could see my family and stuff so.

I just think that the, the fact that they were so nice has helped me deal with it. Because I was just so shocked when I got diagnosed and I was worried about everything, about my, my health and my, just everything. And just the fact that they were so nice and helpful just really reassured me that I was going to be okay and everything was going to be fine.

And I just wondered if they sort of allowed that within the trial, you know, within this information giving, whether they, did they give you time to express how you were feeling?

Joe' Yes, yes, I think they did. Because, well I wasn’t always with the nurses and st
 

Staying in hospital as part of the trial, Joe learnt about diabetes, how to do insulin injections...

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Age at interview: 15
Sex: Male
Age at diagnosis: 15
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So tell me about what you had to do? So you took part, you agreed, so what, what happened then?

Joe' Well, I, as I say, I stayed in hospital for three days. And I just had to just go with like, they, they, they, they showed me how to do my injections and the, where to, where to inject, and they just, they d-, tell me to do my blood tests and stuff and –

Mum' You had to keep a record.

Joe' Yes, keep records and, which I still do. Which is really good because it’s helpful when you go back to see them. Yes, keep records and regular blood, blood tests. And just, they had to just keep an eye on me. And that was all.

Mum' And we go and see the nurse who, who put, who does the trial with us, if you like, the diabetic nurse, don’t we? Regular.

So you see her? I mean did they say, was it just, the trial, was that just for three days or did it go on longer?

I think if people aren’t coping very well with the diabetes then they have to stay in longer. But if you just cope with it really well, they, they say after three days that you can go home.

But you’re still part of the trial then as well?

Yes.

Mum' Now, yes, yes. It goes on for a while, doesn’t it?

I’ve got no idea.

Mum' I think it’s about, is it? a good few months, isn’t it?

Joe' I think it was, yes.

So tell me what the trial was about then. What were they, what was, what were they doing?

Mum' It’s to see if people cope better at home or –

Joe' In a hospital.

Mum' it’s best to be in hospital.

Joe' Yes, you know, for when people get first diagnosed. Because, as I said, it was a big shock and hard to deal with at first. And the trial was just to see if people could deal better at home, you know, in their own environment and with everyone they know around them, or in hospital where they can be, ask questions.

Mum' And we found we preferred the hospital with people on hand who know about it.

Joe' Yes.

Mum' Don’t we?

So you sort of, after being in the trial you kind of preferred that option?

Mum' Yes, yes

So what happened, during the three days you just stayed in and they showed you –?

Joe' Yes, they explained everything about my insulin. Like there’s NovoRapid and Levimir insulin which is, the No-, the NovoRapid is when you eat, which is, like quick acting insulin, and the Levimir is the one I have of a night. And they explained me what time to do it and stuff and when to do it and how many times to inject a day. And they, they, they went through my diet and stuff.

Mum' Saw the dietician.

Joe' We saw the dietician and she explained everything xx.

Mum' And carb counting.

Joe' And any question I had, they, they answered.

Mum' And still do, don’t they?

Joe' Yes, they still answer us.

Mum' We just have to phone up and…

Joe' Yes.

It’s really good, isn’t it?

Joe' Yes.

Mum' The nurse will phone

Because Joe was coping really well with his diabetes, he stayed in hospital for three days as part of the trial, but he could have stayed in longer if he needed to. Now that he is at home, he is still monitored as part of the trial and attends three monthly clinic appointments at the hospital to see how he is coping at home.
 
Some young people attend a day ward at the hospital to receive treatments. Attending a day ward varies according to the type of trial. You may be in a room on your own or you may be in a room with other young people who are receiving a similar or different treatment. Jenna is taking part in a three-year trial on improving treatment for arthritis. She has been in the trial for one year and attends a day ward once a month, but at the start of the trial it was every two weeks. 
 

Sometimes a cannula is inserted to receive the trial drug, but Jenna says it doesn’t hurt and...

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Age at interview: 13
Sex: Female
Age at diagnosis: 11
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What was involved and how, how was that?
 
Jenna' Well, I had to get up quite early to go to the hospital. And when I got there they’d like, they’d put a cannula in my arm and take some blood, because like you have to take different measurements like each time because they’d like test different stuff with it. And then they would like make the medicine. And then they’d just like sort of hook me up to it and it would take about, about an hour or something or an hour and a quarter to do it. And like during that time they had to like sort of do my blood pressure and my temperature and my pulse and stuff like that.
 
Did you have to go into hospital to have that done, to stay in, or did you have an outpatient?
 
Jenna' No, I stayed in.
 
You stayed in? How long did you have to stay in for that?
 
Jenna' Well, it depends really, because like they do different stuff. Because sometimes I have to fast, so they do that quite quickly because like I’m hungry. And sometimes it can take quite a long time, because it takes a couple of hours or something for the medicine to like be made.
Mum' She goes on to a day ward. So you, you’re more, she’s not really an inpatient as such. It’s just a ward for things like dialysis I think, you know, things that need doing regularly. But they can just come in and have it done and then go home.
 
So there’s like a bed for you?
 
Mum' A chair.
 
Oh, a chair.
 
Jenna' There are beds.
 
I hope it was a comfy chair.
 
Jenna' Yes.
 
I' So how many times do you have to go?

R' [um] well, now I have to go once a month for about half a day or something like that.

I' And has that always been or has that changed over time?

R' [um] It’s changed, because like I had to go every two weeks for blood tests and then like once a month for the thing. So, because there’s like different parts of the trial.
 
 
so you go for the day and you have a cannula inserted every time for the drip? How does that feel, when you have that done?


R' Well, it’s just like a sharp scratch. But you don’t feel anything once it’s gone in. And it’s just quick. But sometimes they can’t find the vein and like it goes all weird. So that sort of like makes me feel a bit queasy. But it’s not really that bad if it goes right.


I' If it goes right, yes. And hopefully the nurses get it right every, nine times out of ten. And, and you’re there then for the day. How long does the drip take?

R' [um] About an hour or something like that.

M' I would say an hour and a half to two hours. Because they have to put a flush, what they call a flush through after the drip. And then you have to stay for a while after that before they take the final set of observations before you’re allowed to go home.
 

 

 

Ryan prefers to attend the day ward to receive the trial drug; even though he has to wait for the...

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Age at interview: 12
Sex: Male
Age at diagnosis: 8
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I had to have a joint count on it, no, a joint count and then a blood test. And then we had to wait till the drug was made. Because we had to get, we had to get told to, that we, I was allowed it by the drug company that provided it. And then they made the drug, which took an hour. And then I sat in a chair and then I got a needle in my arm.
 
And that’s what, was that the drip?
 
Yes, drip.
 
And how long, was that like a day appointment?
 
Yes.
 
Just for one day? And how long were you having the drip for?
 
An hour, and then I think there was a 20-minute flush at the end.
 
What does that mean?
 
A flush. Where they just put water in it, so the rest of the drug goes through. Because sometimes there’d be like a little bit left. But there’s this ball that stopped it when it got too low. So if they put water in it, it’ll, the ball will go back up and put the rest of the drug through on the drip.
 
So that’s all on the drip? And that’s, do you have to go in to a little room to have that?
 
No, it’s like, because there was quite a few people having it. But not all the people had the same thing.
 
So you just had to sit in a chair?
 
Mum' You have a nice chair, don’t you?
 
Yes.
 
But were there other children your age? You know, were you able to talk with all them?
 
Yes.
 
But they weren’t all having the same thing?
 
No.
 
And what happened after the, when they’d done the drip and they’d flushed it, what happened then?
 
I had to wait like a few minutes and then I’d be allowed to go. But they had to take the drip thing out.
 
And did you mind do, going in and having the drip done? You know, was it better than –
 
Yes, it was better than having the needle at home. Because sometimes I, I try and walk home dead slowly and try and put off coming home.
 
Did you? Because you didn’t want to have the needles?
 
No.
 
And is that because they were painful?
 
Yes. And I felt dizzy and sick.
 
Did you? Was that from having the needle? Or was that the drug that made you feel…
 
From having the needle.
 
From having the needle? It really made you quite anxious?
 
Yes.
 
You’re not alone in that. It’s, it’s never nice, having needles, is it? If you’ve got to have them every day. So you didn’t really like coming home then?
 
No. And I started getting angry at my mum because she was the one that was giving me it.
 
Did it make you feel better when you, after you’d been angry?
 
Yes.
 
So how did it, when, once you’d had it done, were you okay? Was it just the thought of having it done?
 
I was a bit feeling sick after it.
 
Were you? And the, but the drip, although it’s still a
A cannula is a flexible tube inserted into a body cavity, duct or vessel to drain fluid or give treatment. Sometimes a small surgical procedure is done to give a drug through a ‘central line’ which is removed at the end of the treatment. Eden was diagnosed with Hodgkin’s lymphoma and took part in a trial that involved taking four different types of chemotherapy through a ‘central line’ inserted into the main vein in her neck. The treatment was in cycles of 5 days with 2 days off then 5 days with, 2 days off, and a final 5 day treatment. She was pleased to be attending a day ward with other young people of her age. 
 

Having a central line inserted was worrying for Eden, but meeting other young people who had a...

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Age at interview: 17
Sex: Female
Age at diagnosis: 16
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Eden' Because I didn’t know about the line and how it would be and they showed me on, they had a doll and I got a bit scared of it and started crying and felt dead sick. So they explained and they asked one of the kids and asked them to show me it so I got showed just how it went in and that then. So I weren’t that like sacred.
 
When he said they took you to one of the children, was that somebody who had had a central line in? (Yes.) And they showed you what it was like on them?
 
Eden' Yes because it looked different on like this doll.
 
Mum' We were devastated she was going to refuse the treatment she was going to walk out the hospital. She was absolutely, she became so angry it wasn’t going to invade her chest.
 
I can imagine yes.
 
Eden' Because I already had two scars on my neck and there is a hole now, I didn’t really want it so.
 
Is that what you were worried about having the scars?
 
Eden' At first yes. And then, and then like they took the plasters off they looked dead big and I started crying and that’s why I didn’t want a central line and they just faded. It’s just a mark and you’ve got to get over it.
 
But at the time it was quite a bit daunting?
 
Eden' Yes, yes.
 
And so did you have questions to ask about the central line, did that reassure you that they can explain it?
 
Eden' Yes, I felt better then when I’d seen it. But there was a kid about four and he was running round and he had crayons in his hand and he was going ‘Look, look it doesn’t mean nothing, it doesn’t hurt you, it doesn’t hurt you’ and was just running around so I was like well if he can do it I can do it.
 
Do you want to explain what happened each day, you know, how, what they did to you?
 
Eden' You had to go, you got weighed, you went and got weighed and then the consultant had to come in and check you over to make sure you were fit. And then the chemo would get sent up from the pharmacy and then you’d get plugged into the machine and it would, then it would just start going in.
 
And into the line?
 
Eden' Yes.
 
Through the... a tube into where they’d made the...
 
Eden' Yes like it clipped together.
 
And how long did you have to have that for, how long did it take?
 
Mum' Over five days, day one would be all day with all the drugs.
 
Eden' Yes like day one would be every drug because that was like five hours weren’t it? Day two would just be two so it would only be like two hours. And then day three and four would be just two and then day five you’d have all the drugs again together so that would be another five hours.
 
And when you, so it changed every day?
 
Eden' Yes.
 
And when you say the drugs is that the chemo, the chemotherapy?
 
Eden' Yes but there was different types wasn’t there? There was vincristine and a red one that used to go in as well.
 
A red one, did they all have colours?
 
Whatever the intervention, staff running the trial will probably want to monitor progress and this may mean attending appointments for tests and discussion, as well as for treatment. (See also ‘Side effects’.)
 

Katie had to attend the hospital every two weeks for tests and complete a short two page...

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Age at interview: 13
Sex: Female
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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.

 

Knowing that they would be closely monitored was reassuring for many young people. Sometimes young people received calls at home from the doctors.
 

Continued monitoring is an important part of the trial. Jenna has lots of different tests done...

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Age at interview: 13
Sex: Female
Age at diagnosis: 11
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Just describe to me all the tests and things that you’ve had to do?
 
Jenna' I’ve had to have like this thing under my skin for TB and like the next day I had to go to the doctor’s, or like 24 hours or something. And it, if it swelled up that means I’ve got TB and I couldn’t do it if I had that. And they did an X-ray on my lungs to see if I’ve got it. And they did an MRI, which is where they like, sort of like magnets and they sort of look inside you and you have to stay really still. And like I’m a bit claustrophobic so I didn’t really like that. But like they have little videos that you can watch, like The Simpsons and stuff. And so like you can watch stuff, like you can lie down and you have these like mirror glassy things like so you can like be looking at the ceiling but you’ll be able to see it through all the mirrors. I don’t think I had to do anything else.
 
Mum' X-rays, normal X-rays.
 
Jenna' The X-rays.
 
Mum' The main thing is the blood tests. And they regularly, they regularly test the blood at first to make sure that everything is going okay and that she’s reacting okay to the medicine. But once she’s been on it a while it’s just done on the day that she has the treatment. So it’s a lot, a lot better now.
 
Jenna' I think at first I was a bit worried because like I had to have loads of blood tests and I haven’t had them that often. But now I’ve sort of got used to them and like I’m not really that bothered about them anymore.
 
Most things that children say, they don’t like blood tests.
 
Jenna' Because like everyone asks me if it hurts and I say like it doesn’t. Because like we had, we had to have like injections and they were like, “Which hurts more, blood test or injection?” I was like, “Injection.” And they were like, “Really?” and stuff. But they give you like loads of options, like you can have this spray that sort of numbs and then you can like get cream as well. So, but I didn’t really have any of that.
 
So you were brave then. I think they call it Emla cream or something, don’t they? Magic cream?
 
Jenna' Yes.
 
So, but, so you’ve got used to having the blood tests now? And do they take much blood?
 
Jenna' No. Just like a teaspoon or something usually. It’s not that much. It looks a lot more but it isn’t actually that much.

 

 

The blood tests enabled the doctors to keep a close eye on Lois and make any changes to the dose...

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Age at interview: 14
Sex: Female
Age at diagnosis: 13
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Lois' I like the people that did the blood, were dead nice and stuff and you got like a little, like, you got like antiseptic and it wouldn’t hurt at all or anything.
 
Right, so was it like, did you mind, how did they take the blood was it in like a tube or?
 
Lois' Yes.
 
A pin prick?
 
Lois' It was like a pin prick and then they’d take it out my finger and stuff because like they had to stop taking it out my arm because they thought my veins were going to collapse because they were taking that much blood out of me. So they said which one, you can have like your hand like your finger if you want and I said yes and it’s a lot better because it doesn’t hurt at all.
 
Oh right so you had a choice then?
 
Lois' Yes.
 
Oh right so they just took some blood from your finger in the end because you may, because you?
 
Lois' Yes they were getting like worried and stuff and like every time they like tried to get blood out, we’re going to have to be careful because your veins collapsing.
 
Oh right and is that part of the condition or, do you think or?
 
Lois' No I think it like it can happen sometimes if you take like loads and loads of blood out like at one time, you have to be careful of like your veins collapsing.
 
Mum' No what we have to do is every time we go for a specific visit it’s set out in weeks so the trial dictates more or less where we go but if say something, when [Lois] has her bloods done we get a phone call that night from the consultant.
 
Oh right so he tells you straight away?
 
Mum' Yes he phones us personally and discusses it with us which I’m very, you know, I’m very impressed with and things.
 
It’s like he phones at like half past eight at night.
 
Did he?
 
Lois' Yes.
 
Mum' One night he phoned at 10 ‘o’clock wasn’t it on a Friday night.
 
So what do they tell you when you’re being, when you’ve had your blood test?
 
Lois' He tells me like the results of the blood tests and were they okay and stuff like that. And like, like I think one occasion he went, so he got me a hospital appointment and then he changed my medication.
 
Has he changed it has he, did he say why did he changed it?
 
Lois' Well I ‘vet been feeling under the weather and so I think he got, so he said right we’ll go for a blood test and he lowered my medication then.
 
Right, but you’re still on the same on but the just changed the dosage did they?
 
Lois' Yes they just...
 
That’s interesting.
 
Mum' Then they upped it didn’t they?
 
Lois' Yes and then like they upped it again and...
 
Mum' The trial dictates really so, but if something like say when we go on Thursday for, because we’re due on Thursday for [Lois’s] blood that goes down as an extra visit on the trial. And all her results are done because they do your bloods, your weight and your blood pressure and your pulse all the time.
 
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In addition to asking about your physical health and wellbeing, researchers may ask questions about your activities of daily living.

Questionnaires may be used to assess physical symptoms as well as practical things such as exercise, school and social activities, and to find out how someone’s emotions or mental state are affected. Saskia and Danny had to complete three questionnaires as part of a trial, and Danny was also interviewed by a research nurse. Both their parents also completed separate questionnaires.
 

Completing the questionnaire at the clinic was easy to do and didn’t take very long.

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Age at interview: 13
Sex: Female
Age at diagnosis: 11
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What do you think you were filling the forms in for?
 
Well, probably, I was there probably to help other children who have got diabetes, to help them probably get through it.
 
And what was, what were the forms about?
 
Probably like it’s just everyday questions like, “Can you get up? Can you get dressed? Do, do you find it hard to do exercise? Do people understand your diabetes?” All different questions relating to life.
 
And were they easy questions for you to, to fill in?
 
Yes, very easy.
 
Were they? Was there many?
 
Yes, there was a lot.
 
So how long, how long did it take?
 
About 20 minutes, maybe half an hour.
 
And how many times did you have to fill in the questionnaire?
 
Two or three times.
 
And each time was it the same?
 
Each time it was, it was slightly modified in, in different ways. I think maybe added a few more questions on might have answered a few more questions.
 
Can you remember what the questions were?
 
Some questions were like, it was all put in different, I think it was put into three or four sections about like, “Can you, do you find it hard to wash yourself?” or, “Do you find it hard to get up, brush your teeth?”, and do all that, or, stuff. Or, and other parts were like, “Do you friends understand diabetes? Do you find it difficult to do exercise at school to do your homework?” and stuff, stuff like that. Which I found, I found really easy.

 

 

The interview at the end of the trial allowed Danny to express his feelings. He felt he could say...

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Age at interview: 13
Sex: Male
Age at diagnosis: 4
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When, I think when I got the questions they were more like easier to say in your head. So when you read it, it’s like really easy to understand. And then you had like 1, 2, 3… 4 being like never and 1 being almost always, and stuff like that. I didn’t see the parent one but I think that must have been a lot harder.
 
So it was easy for you to complete as well? It wasn’t like -- -- complicated words? Just like tick boxes and numbers?
 
Yes. Tick boxes and circle words and numbers.
 
That’s straightforward then, isn’t it? If it had been wordy would it have been more complicated, do you think? If you had to write more?
 
It could have been a bit more like, if they would have used more like complicated words, it would have got a bit like confused in your head. After a, after you’ve done like most of them and you’ve got a last few left, you just get like a bit stressed in your head.
 
Stressed in the head – a bit too much? So they made it nice and clear for you? And did you understand all the terms that were used? Were there any word you didn’t understand?
 
I did understand all of them. Yes, there weren’t any words that I didn’t know.
 
And in terms of your experience, the whole thing, have they said anything about the results of anything yet? Because you filled in three questionnaires? Do you know if it’s ended?
 
I don’t, I’m not sure if it’s ended or not. They haven’t, I haven’t had any results yet.
 
I know I’ve had an interview from someone from the trial and they were asking me like, like how long I’ve been living with diabetes and, the same questions that were in the book really. They just wanted to get it on like, um on tape.
 
So they did that, was that at the beginning?
 
No. That was, I think it was near the end. I don’t know if it’s finished or not. I really don’t know.
 
So that was after the third questionnaire? They came out and interviewed you like this and had a little -- -- recorder? And did they ask the same sort of questions as on the paperwork?
 
Some of the questions were. It was more about like, because when you’re doing it in a, like a question form, you don’t have many like, well, it says, “How do you feel about it?” and it says, “How do you feel about diabetic?” And [are you] sad, happy is, they’re the only like couple that you get. But in, when you’re doing it in person you can say more; you can say more than you can than writing it down.
 
So do you think that was a good thing, that you were able to clarify some of the things?
 
Yes. Yes, it was.
 
Because it’s a bit sort of one thing, isn’t it? If it’s sad, happy. You can be sad, but you’re not, you need to explain that - don’t you really? So that was good?
 
Yes.
 
Did it take long, the interview?
 
No. It took about half an hour with me and then they had um I think about the same for my mum and dad.

 

Sometimes completing questionnaires prompted useful discussion with their parents.
 

Hannah would often discuss things in the questionnaire with her parents; and sometimes they...

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Age at interview: 17
Sex: Female
Age at diagnosis: 4
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And you filled in two?
 
Yes. And my parents have filled in; I think my parents only filled in one. Because I didn’t go to the clinic with my mum, so I brought one home and she forgot to fill it out. So they sent me another one in the post and then she sent that one off. It was just asking about like my health and like what involvement she has.
 
And, and did you compare notes, you and your mum?
 
I was, I was interested in what she was putting. But, no, because I’d already sent mine off. So…
 
Did you have a look at what your mum put?
 
Yes.
 
Did you agree with her?
 
Yes, pretty much.
 
So you were okay with that?
 
Yes.
 
So you kind of discussed it a little bit?
 
Yes. Because there was a few questions about my health and mum brought up the topic but, and she says that maybe I’m not controlling it as well as I could be.
 
Is that true?
 
It’s all right. I’ve got a lot better now. It’s just my laziness.
 
Is that because you have to do regular injections?
 
Yes, well, every time I eat I have to inject. It is hard when you’re at sixth form and college and stuff, just remembering. I never forget my insulin but it’s just whether I do it a bit later. And I’ve got to regularly check my blood sugars.
 
So it’s remembering to do the things you have to do? But the, taking part in the clinical trial didn’t take up much time?
 
No, no.
 
It didn’t interfere with –
 
It didn’t interfere with anything, no.
 
Because you did it at the clinic.
 
It’s quite nice to be a help really. Because not many people do like, do things like that really any more.

 

 
You may be asked to record what is happening in other ways, for example, by keeping a diary or filling in a chart. Sophie took part in her first research study to test a blood glucose monitor called a Continual Blood Glucose Monitor System, specially designed for people with cystic fibrosis. 
 

Wearing a monitor for four days, doing a finger prick test four times a day and keeping a diary...

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Age at interview: 23
Sex: Female
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And this was first mentioned to me during a clinic appointment with my doctor. And she said we could arrange it at a convenient time for me. And it required for me to go and have the monitor fitted and then any time on day two, three or four I had to have an oral glucose tolerance test which is what I mentioned before. So to make it more convenient for me, I was having an annual review at the hospital, so I decided that would be the best time and I arranged it with my doctor so I went and had the monitor fitted the evening before, so after work I went to hospital and had the monitor fitted. And, this monitor, just was on the lower part of the, of my tummy, and the sensor just rested below the skin. So when I went in to have it fitted my doctor explained everything to me and then she said it had to have like a special, there’s a special device used to fit it. It maybe stung a little bit as the monitor was fitted. And once it was fitted we had to wait for about half an hour for it to settle and then once it was settled the doctor had to make sure that the monitor connected to the to the reader.

Because it had this little sensor and she had to just make sure that it was reading my the blood, the sugar levels just below my skin. And then once, once that was all set up my doctor explained what I would need to do to carry out the study which, which was three main days but I had the monitor attached for four days. So once the monitor was attached, my doctor talked me through what would happen and that basically included taking a blood sugar level from my finger prick four times a day. So she showed me how to do this because this is something I’d never done before. So I, she showed me how to do that and then she showed me how to record it, how to record my blood sugar level. And she made sure that, she actually did it to herself to demonstrate and then I could do it to myself to show that I understood. And then I had a record sheet which I had to fill in. And I had to record everything that I ate over the three/four day period. And what was really important was that I took the blood sugar level at least, the finger prick level, at least three times a day, ideally four times a day because then that matches up to the sensor.

So without the readings of my blood sugar levels from my finger prick it wouldn’t be able to accurately link, link it together with the sensor. So that was really important that I did that. So we made sure I understood how to do that.

And then over the top of the sensor was placed like a plaster or like a, just to secure it on to my skin. My doctor explained to me that it was okay to continue with all normal activities and that I could still have a shower or a bath, you know. She gave me a replacement plaster if I needed to change it over the period, over the few days. And then, and then I went away that evening and it did feel slightly uncomfortable at first and it took a little while to get used to, and even then sometimes, I’d, because it was like having something attached to me. It wasn’t big and cumbersome but I was very much aware that it was there.
 

 

Alexander was given a booklet to keep a daily record of his health including his temperature as...

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Age at interview: 18
Sex: Male
Age at diagnosis: 16
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Did you have to fill anything in at home about recording things?

Yes, I had to, when I, I actually still have a book I have to fill in if I have any temperatures, if I feel sick, if I have any new symptoms. I have a headache quite recent, quite often. So I have to put that, every headache I have and what pills I take for it. So there’s the rash chart too, from the old rash. If that occasionally does come up you have to scribble that in. Or the temperature chart. So you have to, if you’re ever feeling a bit ill or you’re feeling like you have a headache, you have to take your temperature and describe what’s going on there.
 

Children who took part in vaccine trials had injections and blood samples to check what effect the vaccine was having. They were also asked to monitor their health at home, by recording changes in their temperature, redness or soreness around the injection site, and any other changes observed in their health. If they were concerned about anything they were asked to ask for medical advice immediately. As with many young people we spoke to, needles were a common dislike and this included having blood samples taken. 
 

Will was a bit nervous about having blood samples taken, but the ‘magic cream’ helped and he soon...

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Age at interview: 12
Sex: Male
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Will' I was asked to go to the Children’s Hospital to have, nine, for a swine flu trial for the test of the vaccines. The first time I went, we, we had, I had a blood and a jab, and the second time we went, three weeks later, I had just a injection. And then the last time, three weeks later, I just had a blood.

Tell me about what happened, the process, what you had to do, how many appointments you had and what you had to do at each appointment.
 
Will' Well, I had three appointments. And every time we got, we had to wait in the waiting room and there was entertainment like Nintendo 64s.
 
Was that the good bit?
 
Will' It was. And then they would ask you in for your appointment and then they would tell you what they were going to do. We had three appointments and as I explained earlier there were different things that happened in them.
 
So what happened in them, each one?
 
Will' Well, the first one, I had the information, a blood, then a injection. And then the second time, three weeks later, I had an injection. And the third time, three weeks later, I had a blood.
 
So there were three, three different appointments? Were you very long at each appointment?
 
Will' About, at the max about an hour and a half.
 
Mum' That was the first one.
 
Will' Yes.
 
So the first one was quite a long time because they were talking to you?
 
Will' Yes.
 
And the second one they were, did you have to wait very long at all?
 
Will' About –
 
Mum' Half an hour.
 
Will' Yes, about half an hour, I had stuff to do.
 
What was it like? Have you had blood, blood tests before?
 
Will' No.
 
What was that like for you?
 
Will' It was fine because I didn’t really feel a thing when that cream was on me.
 
So that was nice to have that, the magic cream? So they did, gave you that every time?
 
Will' Yes. They, they also gave you a tube in the information pack when you went away. So you could put it on like 45 minutes before.

 



Last reivewed March 2017.
Last updated July 2014.
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