ISRCTN60243484
PATIENT INFORMATION SHEET
Study title
"Conducting Research in Palliative Care: Finding the Best Way Forward"
1. Invitation paragraph
We are trying to find out if palliative care patients need an anti-sickness medicine in the
syringe driver. We know that there are difficulties recruiting palliative care patients into trials,
in particular the issue of informed consent. Before you decide it is important for you to
understand why the research is being done and what it will involve. Please take time to read
the following information carefully and discuss it with relatives, friends or your GP if you wish.
Ask us if there is anything that is not clear or if you would like more information. Take time to
decide whether or not you wish to take part.
Consumers for Ethics in Research (CERES) publish a leaflet entitled ‘Medical Research and
You’. This leaflet gives more information about medical research and looks at some questions
you may want to ask. A copy may be obtained from CERES, PO Box 1365, London N16
0BW.
Thank you for reading this.
2. What is the purpose of the study?
We are asking if prescribing an anti-sickness medicine as routine when starting a patient on a
syringe driver is needed. In the study some patients will not have an anti-sickness medicine
as routine, if symptoms of nausea and vomiting develop an anti-sickness medicine will be
given immediately. Patients who are already receiving an anti-sickness medicine when
entered to the study will continue their normal medication. The research study will run for
one year and is aimed at finding the most appropriate research design for use with palliative
care patients. The outcomes of this study will inform the development of a much larger
Wales-wide study and contribute to the on-going improvement of care for palliative care
patients.
3. Why have I been chosen?
The research methods being used for this study ask that consent to take part be sought from
the patient when they have been selected into the study.
4. Do I have to take part?
It is up to you to decide whether or not to agree to take part in the study. If you do decide to
take part you will be given this information sheet to keep and be asked to sign a patient
consent form. If you decide you are taking part you are still free to withdraw at any time and
without giving a reason. This will not affect the standard of care you receive.
5. What will happen to me if I agree to take part?
Sometimes because we do not know which way of treating patients is best, we need to make
comparisons. Patients will be put into one of two groups and then compared. The groups are
selected by a computer which has no information about the individual – i.e. by chance.
Patients in each group then have a different treatment and these are compared. Our usual
practice is to give patients an anti-sickness medicine when we start a syringe driver. In this
study you will not have the anti-sickness medicine unless you feel nauseous or are sick, in
which case you will be given an anti-sickness medicine immediately.
6. What do I have to do?
Nothing at all, if you feel nauseous or think you might vomit tell a member of staff and an antisickness medicine will be given to you. If at any time you feel that taking part in the study is
causing you undue stress you can withdraw from the study.
7. What is the drug or procedure that is being tested?
A syringe driver is a battery operated device for giving medications through the skin, so
continuous pain relief can be given, resulting in a comfortable pain-free patient. Sometimes
adding an anti-sickness medicine (with other drugs) to a syringe driver leads to the liquid
medicine thickening up and becoming crystallised. This results in stopping the delivery of
pain relief and the patient may experience pain.
8. What are the alternatives for treatment?
We usually give patients an anti-sickness medicine when we start the syringe driver. We do
not know if this helps the patient or not.
9. What are the side effects of taking part?
The side effect of taking part in this study is that you may get symptoms of nausea and or
vomiting. If these symptoms occur an anti-sickness medicine will be given immediately.
10. What are the possible disadvantages and risks of taking part?
The incidence of nausea and vomiting during this stage of the illness is small, if you do get
nausea and/or vomiting an anti-sickness medication will be given immediately.
11. What are the possible benefits of taking part?
The benefit to the patient from taking part in this study is that they are likely to be less
troubled with medications and the risk of medications crystallising in the syringe driver is
reduced. The information we get from this study will help us to improve the treatment of future
palliative care patients.
12. What if new information becomes available?
Sometimes during the course of a research project new information becomes available about
the treatment or drug that is being studied. If this happens, your research nurse will tell you
about it and discuss with you whether you want to continue participating in the study. If you
decide to withdraw from the study your research nurse will make arrangements for all care to
continue as routine. If you decide to continue in the study you will be asked to sign an
updated patient consent form.
13. What happens when the research study stops?
The study will run for one year at the end of which, it is expected that the prescribing of an
anti-sickness medicine when starting a syringe driver for palliative care patients will continue
as routine pending the outcomes of this and further studies.
14. What if something goes wrong?
If taking part in this research project harms you, there are no special compensation
arrangements. If you are harmed due to someone’s negligence, then you may have grounds
for a legal action but you may have to pay for it. Regardless of this, if you wish to complain
about any aspect of the way you have been approached or treated during the course of this
study, the normal North West Wales NHS Trust complaints mechanisms will be available to
you.
15. Will the notes of patients taking part in this study be kept confidential?
All information, which is collected, about you during the course of the research will be kept
strictly confidential. Any information about you which leaves the hospital will have names and
addresses removed so that you cannot be recognised from it. The only people who will have
sight of the original notes will be the research nurse assigned to the study.
16. What will happen to the results of the research study?
At the end of the study period a report will be written up detailing the outcomes of the study.
A copy of the report will be made available to the healthcare professionals participating in the
study. A copy of the report will also be made available to the North West Wales NHS Trust.
It is intended that the outcomes of this study will be published in peer reviewed journals.
Individual patients or hospital sites will not be identified in any way. It is expected that the
outcomes of this study will inform the development of a Wales-wide trial in palliative care.
17. Who is organising and funding the research?
The study is funded by a North West Wales NHS Trust Research Grant and supported by the
North West Wales NHS Trust. Your doctor will be not be paid any extra fees for including
patients in this study.
18. Who has reviewed the study?
North Wales Health Authority Research Committee (West, Central & East sub-committees)
19. Contact for Further Information
Dr A. Fowell
Macmillan Consultant
Palliative Care Department
Bodfan
Eryri Hospital
Caernarfon
Gwynedd
LL55 2YE
Tel: 01286 662 775
Thank You for Reading this Information Sheet.
The Patient will be given a copy of the Patient Information Sheet' and a
signed 'Patient Consent Form' to keep for their records.