We want to find out how cancer treatment works and how it affects patients and learning how people experience this treatment by responding to some of the questions that measure how the impact is perceived by the patient, that’s very, very important to know exactly how it is to be a cancer patient.
Why is it important to consider the patient voice in a clinical trial setting?
That is in continuation of what we talked about – to learn whether different treatments have different impacts on patients is very important. Sometimes there may be some consequences of undergoing a treatment, there may be some side effects, there may be some limitations in daily life and knowing particularly whether there are differences between different treatments about how people are affected, that’s very important.
Could you describe in some detail the assessments you used?
We talked today about the importance of using questionnaires that are very carefully developed and validated so that we know that the responses we’re getting from these questionnaires are reliable, that they are valid, so that we can trust them. That’s the first very important thing, that we use these well-known and well documented scientific methods which are questionnaires for assessing quality of life.
How does this compare with other measures of quality of life?
We talked today about the new development which is that we need to be able to be flexible. So one part of it is to know exactly what we are doing and to use the right measures but the other one is to also have the courage to make sure that we measure all the right things. So one of the very important new developments in our field is that we combine the questionnaires we know with items about the specific components of quality of life that may be affected, some particular symptoms that may be related to a new drug, for example. That means that we have to combine what we have been doing in the past, which is to use these very good scientific questionnaires, with additional items that can be drawn from what we call an item library where we can pull new items about the side effects of treatment that are related to the new treatments. In that way we can get a comprehensive overview where we both measure what we have always been measuring but also potentially the new side effects that people experience.
What are the pros and cons of your assessment?
To some people it’s a bit confusing to say that we need to use this very carefully evaluated instrument that they have known for a long time and then at the same time we say that you also have to find out whether anything is missing and whether, in fact, you would need to add some questions to your questionnaire. That’s counterintuitive because we know that it’s very important to keep it very strict but then at the other time we also need to go out and be sure that we know whether any additional things should be entered into our studies.
How can the outcomes of this assessment impact the clinical trial?
In clinical trials we have two situations. One of them, and that’s still relatively rare, that’s trials where we have quality of life as the primary outcome. We see that in palliative care and in other situations where we, for example, want to improve on how people feel and then we compare different strategies to do that. The other situation is when we want to compare some treatments and possibly they have different impacts on quality of life. In that case it’s very important, first of all, to capture this difference in impact, to find out how people perceive the treatment, because that allows us to find out whether one of the treatments is better and also possibly to communicate to future patients that if you will receive this treatment these are the consequences you may experience. By doing this we can prepare people to do this and we can also alert the doctors and nurses to the possible consequences so maybe they can provide some additional treatment that can alleviate some side effects or at least talk with patients about it.
In what ways have these assessments altered general guidelines?
What we have learned over the years is that we are not always able to guess in advance how these results are. So we have seen several cases where we found out that the treatments were different where we didn’t expect it or where we found out that they were, in fact, similar. That has been taken into consideration when recommendations about the choice of treatments have been made.
Could you provide a specific example of this?
One particular very, very important example at the moment is about the integration of palliative care in oncology where we have had some very important trials showing that if people are offered palliative care, contact with the palliative care specialist, early in the disease course then they will have improved quality of life and potentially also improved survival. So that’s very important results that have shown that we can, in fact, help people by assisting them earlier on.
What are the next steps for your research?
The next steps are first of all to assist older people who carry out clinical trials in cancer in order to navigate and find out what are the best combination of questionnaires, how do they implement quality of life in their studies and how do they analyse the results and interpret this. So there’s a lot of work to do with getting this done as well as possible.
