Lisa - Interview 17

Age at interview: 37

Brief Outline: Callum was 2lb 12oz at birth and at the age of four years was small compared to his peers. Since being on growth hormones Callum has now caught up and is nearly the same size as his peers. He continues to be in the trial and enjoys taking part.

Background: Lisa, aged 37 years, is White British, recently married and has two children aged eight and five years. Now a homemaker, Lisa previously worked as a Support Worker. Her eldest child, Callum, is taking part in a clinical trial to test dosage of growth hormones.

More about me...

 Callum was three and a half years old when he started a clinical trial to test the dosage for growth hormones among children under the age of five years. Lisa, his mother, was introduced to the clinical trial by Callum’s paediatrician at their local hospital. Lisa had been told that her son would only reach 4’10” without treatment. She says that “as a lad” this would be unfair on him so decided to enrol him on the trial. However, the decision was not immediate. Lisa talked to the team running the trial, Callum’s paediatrician, her family and of course Callum who was very keen to take part; “Mummy I want to be like other children.” She explained to her son that it would involve daily injections. However, Callum’s Granddad has diabetes and has daily injections so Callum was familiar with injections; “So Grandad has injections so I’ll have injections to make me grow.” Before being accepted on the trial Callum underwent a series of tests to make sure he met the criteria for inclusion into the trial. Callum would have received growth hormones as part of his standard care, being part of the trial meant he would have to have extra blood tests and scans Lisa couldn’t remember if it was a randomised trial, although she knows there were different groups as they told her Callum was on the highest dose. Callum has been in the trial for three years and recently has been invited to continue for another three years, which the family have agreed to. This means that Callum will continue to have blood tests every three months. 

 

A key factor in making the decision to enrol Callum involved her own childhood experience of being bullied because of her size and she did not want that for her child.

 

Callum feels good that he is helping other people like him in the future. Callum also knows that he can withdraw from the trial at any time and this wouldn’t interfere with his normal care and treatment. Lisa felt it important that Callum was very much part of the decision to take part in the trial and coming off the trial. Lisa hasn’t yet received any feedback from the trial in terms of the overall progress although she does know Callum’s progress. He is doing really well and is so much more confident at school too. All travel expenses are paid. He has rarely missed any school time so it hasn’t been too demanding in terms of their time and energy.

 

Lisa understands the importance of clinical trials however, the primary reason taking part in the trial, initially, was for Callum’s personal benefit. However, Lisa feels that it is important to be informed of all the potential risks and side effects' “I think you need to go into things with both eyes open”.

 

Having her own experience and her family health background (diabetes) helped her to understand some of the medical terms used in the information pack they received prior to the study. However, she said that “some parents may find it all a bit daunting, the medical terms, names of tests etc, so it is important that these are clearly explained”. Thus, Lisa felt that to improve the experience, the information parents receive about the study could be easier and clearer. Importantly, Lisa advices other parents who may be considering enrolling their child onto a clinical trial, to always listen to your child and speak to other people first before making a decision. Lisa also would like to know the overall results of the study when it is completed. Overall Lisa and Callum’s experiences of taking part in a clinical trial have been positive one, and they both would certainly consider taking part in another clinical trial in the future.

 

Currently they don't give growth hormones to children under the age of five years, so the trial...

 Seeing about different dosages for children who were born less gestational periods than there was, because Callum was born at 33 weeks, but was the size of a 28 week baby. And for children who haven’t caught up, they’re giving them growth hormones to see, but they’re trying to see as well as if, because at the moment they don’t give children under five growth hormones. And they wanted to see as well is if a child was born small, if it would benefit them to giving them earlier on, so they caught up a bit quicker, so then it wouldn’t be when they get to school that they start all this. They would have done it, so they’re looking into what is the best age and what is the best time to start the growth hormones.

Lisa was happy that everything, including side effects, had been explained in the information,...

 I suppose it all depends like we’re quite lucky with this trial that, like it isn’t a lot of my time, and things like that, whereas I suppose some of the trials and different things would be time and be impact of what the trial is and I suppose it depends, because we were given a list of what the side effects could be. So I suppose it depends what the side effects would be, and weighing up what the side effects would be to the what they wouldn’t be.

 

And were there any side effects to your son’s treatment?

 

They did say that there was more risk of being on growth hormones that they, he could develop diabetes at a later on in life. But I have got diabetics in my family, who are insulin dependent, so Callum being a higher chance of getting diabetes anyway it wouldn’t stop me giving him the treatment, just to be diabetic, in case he got diabetes because the chances of him getting diabetes is probably high anyway so. And they said sometimes that can make their legs ache to start with because of being it’s growth hormones, growing pains. But we had none of that with Callum or, and they did say they could get extra headaches, but Callum didn’t have anything like that at all.

 

Well I did sort of look up bit’s about growth hormone on the internet and sort of educated myself that way before, why, because we did have a good few months of deciding if to say, and at one point I was like, we needed a little bit longer to think about it. So they gave us a bit longer because they first were going to put us on when I’d got my, just had, given birth to my little girl, so I said “I need actually, I’ve just had a baby, I need a bit longer”. So they actually gave us a bit longer to think about it.

 

And you were pleased about that?

 

Yeah, that was good that they actually like let us take more time, and that didn’t matter when I said, when they rung up and said, “It’s up to you.” And we had, because they had come out, but I got them to come out again and explain everything again, before when they come out and explained again.

 

It was important to Lisa to involve her son in the decision to take part in a growth hormone trial

And did you talk to him, to your son, about taking part in the trials?

Yes. We sat Callum down and we said about the growth hormones and taking the trial. And said to him about it and what he wanted to do. And explained that if hopefully taking the growth hormones daily would help increase him to grow, and it was up to him if he wanted to take part in it, or not have growth hormones or anything. And he said that, his words were, “Mummy I want to be like the other children.” So to me he wanted to be and like the other children, and we said it would be like an injection every day. And he said, “Well Granddad has it.” He’s a diabetic, “So Granddad has injections so I’ll have injections to make me grow.” And he’s been fine having injections. And he’s just recently learnt to do it himself so he can do it himself now.

Yeah, and we’ve said to him that any time he didn’t want to, but he said that if that helps other children or other people Mummy then I’m helping other people. So he’s like quite proud that he could be helping other people in the future, and he said they could help other people who were born small like me, because he knows that he was born small, and never caught up. So he thinks that if he does this then it will help others. And he like knows that any time, I’ve said to him if anytime he wanted to come out of the trial he could come out of the trial, and just carry on with his growth hormones. But he’s quite sensible and he wants to do it anyway. Because I thought, being a Mum, I’d let him have the, because it’s his life, let him have the decision.

Lisa's son was born prematurely and without treatment would always be small, so when he was aged...

 Okay, Callum started clinical trial three years ago because, and he’s on growth hormones because he was born prematurely weighing two pound twelve, and never caught up growth. So as he was small we decided that he needed something, and we got introduced to the trial. So we decided that to put him on, on it.

 

Yeah. I mean when, was that, were you invited through the hospital?

 

Yeah. He had tests and his growth hormone level was lower than it should have been.

 

Quite a bit of information. There’s things I suppose with everything you learn on the way as well, because there are different tests and things. They just say, “Oh well they’re going to have a Dexa scan,” which at the time you don’t know what a Dexa scan is, and different blood tests and different things which, going into the trial at the time they tell you which some people wouldn’t know what are unless you go for it.

 

Did that worry you at all, not knowing?

 

A little bit, yeah. Because not knowing like what a Dexa scan, and scans and things are, but like I knew what bone age scans and things was because I had them myself when I was a child so I’d been a child in hospital a lot, so having Callum go through it as well was different, he was very tiny and I knew, they said that he would only get to 4’ 10” if he didn’t have no treatment. So we decided that for Callum’s best, being a lad, if he only got to 4’ 10” on the [long hole] when he was older it wouldn’t be fair on him. And ever since being tiny he said he wanted to be a fireman and that, and knowing at 4’ 10” he’d never reach it. So that was one of the decisions why I decided to put him on the trial.

 

Lisa's own personal experience as a small child was another reason for wanting to enrol her son...

 And I had always been a smaller child myself, and I knew from my point of view being picked on and bullied, and I can, all I can remember of school is sitting there crying the whole time. And I wanted something better for my son; I didn’t want him to be picked on. And I thought that being, I was small as a female, being a lad would be even harder because lad’s are bigger and that, and I thought if he can’t do what he wants to do, even at four years old, he would be getting invited to birthday parties and some of them had height limits, and Callum couldn’t join in with other children, he’d have to sit out because of height limits. 

 

Well main, to start with it was mainly the, of what benefit’s Callum would get through it, and how it would make Callum feel and the rest of the family feel. And how Callum would feel at school and things? And then like once he got on it then you start thinking that it can have, this actually can help other people and it, and other children could benefit from what we’re doing. So if it helps one other person, and Callum’s always been happy with doing it so, if Callum actually said, “Actually by the way I don’t want to,” then I’d stop it straightaway because it’s up to Callum.

 

Lisa's son was allocated to the group with the highest dose of growth hormone. She thought the...

With the growth hormones they have different dosage they give different children, and different strengths which they get on and then they look at which children have done differently on the strengths.

 

Did you know which strength you were on? What Callum was on?

 

We were told that he was on the highest strength because they had three different strengths and we just got told he was on the highest strength.

 

So you got, did you, did they talk about being randomised into?

 

I think they, like the first year he was on higher then the second year was something else, and then like the third year was I think like random. And he’s now gone on it because we’ve just re, because he’s done his three years, they’ve asked if we wanted to continue. So he’s now continuing and that’s to, the growth hormone to the level of what he’s missing, so he’s now on the dose which he is missing himself.

 

It’s just, I just usually say like the clinical trial bit is just like where they’re actually put, it’s a bit like number crunching, that they’re actually researching to find out more, to see what they can do to help other people and other children. So that they’re actually looking at each child, and then feeding in the information to see how they’ve developed, to see what they can do to make the medication and everything more effective overall to other people.

 

And if you’d have been put into a lower dose would, would you have minded? That would’ve been, you know, were you pleased to be in the higher dose, did it make a difference?

 

Well I thought the higher dose would have made a more difference, because for Callum being that he was so small, I thought the higher dose would give him a quicker boost to get him a bit bigger where he should be, and it has so,

 

But some parents might be on the lower dose?

 

And I suppose it all depends because with the children as well, they throughout, even if they are on whatever dose, a lower sort of thing, they’re always taking their growth hormone anyway. So, they do tweak within the dose limit’s as well because they have to be on a certain dosage to make it work so, I suppose even if you’re on the lower they would tweak with what your child, because if they’re not producing growth hormone they’ve got to have some to grow. So they wouldn’t be putting them on a dose which isn’t actually going to be any, not beneficial for them because whatever dose they are on it’s going to be beneficial. So they’re not going to give them doses what aren’t going to work.

 

All the family have been trained to give our son his injections and he has now learned to do them...

 Well being about on his growth hormones and it is, but he’s happy being on them and it was recently that he was the one, he said, “I want to do my own injection now. I don’t want people to be doing my injection any more. So, I want to do it.” So he’s just been trained up to do his own injection because he wanted to do it, and then he says, “If I want to go to, out and about, you don’t have to,” because he’s has to have it roughly at seven o’clock every evening, so that could be a bit of a tie. That wherever Callum was he had to have an injection at seven, but most places where he goes, it’s like my parents or family, they’ve all been trained up to give Callum his injection. But now Callum can do it himself it doesn’t really matter where he is, or whatever, as long as he’s got his injection to give it himself at seven. It’s just because Callum does go to bed fairly, fairly early. It has to be just before they go to bed you see. And they like it the same time every night, so it’s just before they go to bed at night, so yeah. We do it at seven because when he first went on it they said make it into like a routine where he has his injection, brushes his teeth and goes to bed. So if you put it in the routine then you don’t forget it.

Knowing the side effects of growth hormones, Lisa was able to make an informed decision to enrol...

 I suppose it all depends like we’re quite lucky with this trial that, like it isn’t a lot of my time, and things like that, whereas I suppose some of the trials and different things would be time and be impact of what the trial is and I suppose it depends, because we were given a list of what the side effects could be. So I suppose it depends what the side effects would be, and weighing up what the side effects would be to the what they wouldn’t be.

 

And were there any side effects to your son’s treatment?

 

They did say that there was more risk of being on growth hormones that they, he could develop diabetes at a later on in life. But I have got diabetics in my family, who are insulin dependent, so Callum being a higher chance of getting diabetes anyway it wouldn’t stop me giving him the treatment, just to be diabetic, in case he got diabetes because the chances of him getting diabetes is probably high anyway so. And they said sometimes that can make their legs ache to start with because of being its growth hormones, growing pains. But we had none of that with Callum or, and they did say they could get extra headaches, but Callum didn’t have anything like that at all. 

 

So he’s not had any of the side effects?

 

No he hasn’t.

 

And if he, if that wasn’t in your family, the diabetes, would the side effects, would that have been an issue there for you?

 

I don’t think for being, because people know a lot about diabetes, and you know how it can be treated and that and so I don’t think that it would have been a big issue because, that you know a lot of people are diabetic and people do get diabetes later on in life, so even though we did, we have got it in our family I don’t think that would have stopped me or Callum. I did say to him that you are more prone to get diabetes later on in life, and you, just well it’s like what Granddad is, and my Auntie is so, he’s grown up with it so.

 

Do you think that’s important when you make a decision to enrol your child onto a clinical trial, do you think having the risks and the side effects clearly explained is important?

 

I think it is very important. The sooner you know what could be in the future or whatever, because if at the moment they say there isn’t like, if you’re not actually told I think you need to go into things with both eyes open, and know what the risks could be, because later on in life if you don’t know and then something happens, they say that is because of that, and you’re going to actually blame yourself. So I think it’s good that they actually told us what the risks and that was, so then you can actually weigh it up' Is it worth it? Is it not worth it?

 

Having information presented in ‘bite size' bits may help to make it easier to read along with...

 I think just really for him, not really for me because I did understand things, I think sometimes some of the things how they bring it across might help other people by their terminology, they use for things because some parents might not understand certain things.

 

What type of things?

 

All about the growth hormone, I can understand, I, like how it works and things like that I think like some parents wouldn’t actually understand or know why they’ve got a deficiency and about the injections and things. Because the leaflets and things they do give you are quite hard in reading, but I suppose because I’m, can understand some things where I think certain parents wouldn’t be able to.

 

So in terms of what you mentioned earlier about the tests and not knowing quite what they were so, like you say, to having things explained...

 

Yeah, I think it’s just the...

 

with what it means?

 

...just the explanation and things sometimes people don’t understand.

 

So do you think the, the leaflets that they give you and the information that’s provided could be perhaps simpler?

 

I think so, more easily read for in terms what some parents would be able to read.

 

Sometimes you just need to break it down, don’t you? [Yeah.] In simple bullets?

 

In bite size bits.

 

That’s good. And if you could change one thing then to improve the experience, would that be it, or would there be something else if you could change anything about the whole experience?

 

Just really more information which you could understand a bit more.

 

Lisa wanted to know what the benefits would be to her son and talked to him to make sure he was...

 Listen to your child. See what your child wants to do, and then see if they’re happy and get as much information as possible, and speak to other people first, so see what other people think about it, and get other people’s opinions first.

 

That’s good. And do you think it’s important, I mean you mentioned about it’s good to help others taking part, do you support sort of clinical trials in general, that is important for children to take part?

 

I suppose it all depends what you was actually testing for and whatever, but for the growth hormones, Callum would be on growth hormones anyway, so having a bit with his growth details and blood results and things put in, into a trial, I don’t think it’s going to harm Callum, so it all depends what the trial was and what it was for then I suppose it depends.

 

You just have to rate each one on...?

 

Each, each trial would be different, and each child is different. And each person is different with their home life and things, so I suppose everybody would have to take it into consideration.

 

And if you were in my position sitting here and talking to a parent is there any question that you would want to be asking a parent about involving a child taking part in a clinical trial?

 

Just that all parties are happy with what they’re doing and things like that, and that they actually know what they let themselves in for, and was happy in doing that.

 

And is there any burning thing that you want to say that maybe I haven’t covered or asked or something you feel may be important that I’ve missed, about you, or just thinking about the whole experience that you’ve had? Going through everything from the beginning to…?

 

No not really, I think just as long as you know what you are actually doing and things like that, which we took great looking into and what was best for Callum, and it has actually benefitted Callum. If it was something what hadn’t benefitted then, then the experience was, would’ve been different.

 

So you had to think about what the personal benefit’s are?

 

Yeah, and what the outcome is going to be, so we’re blessed that the outcomes have had, given Callum, growth hormones have actually worked out good for him. I suppose not every child is going to work out like Callum’s trial has.

 

Lisa's son did miss a few days of school at the start of the trial, but generally the...

 It would just be like hospital appointments and daily injection.

 

And did, was that, you were okay with that? [Yeah.] Were they regular hospital appointments?

 

He had one overnight in hospital 1. And then he’d have like every three months at hospital 2 where the hospital 1 people, come to hospital 2. So they had to come to our local hospital.

 

So you didn’t always have to go to, a long distance?

 

No, we just went once a year to,

 

And did they offer like travel expenses?

 

Yeah, we get all the travel expenses when we go down to hospital 1.

 

And do you think that’s good?

 

It’s really, yeah that is good because going that far like it would have probably been quite a chunk out of your budget to travel there and back so that is good. 

 

And time as well? [Yeah.] Did he have to miss any school at all?

 

When he first had all the first tests when, before he started on the trial he missed two days of school, and he has missed a couple of days when he’s done his yearly visit. But this year’s visit was set up in the Easter holidays so he didn’t have to miss school. And then usually the hospital appointments are usually done after, I book them in for after school anyway, so he doesn’t miss much school.

 

Lisa was concerned that people may take part for the wrong reasons if money was offered as an...

Probably for some people, yeah, because I know some people wouldn’t do nothing for, something for nothing in this day and age, do they? So a lot of people would probably think, “Oh if I’m getting money out of this I probably, I’m more likely to take part,” But that weren’t a case for us. But, I suppose some people are a bit like that aren’t they?