Download OPEN Study: Pain management treatment needs interviews

Participant Information Sheet
We are inviting you to take part in a
research study called the
OPEN Study: Pain management
treatment needs interviews
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Please take time to read the following information
carefully so that you understand why the research
is being done and what it would involve for you.
You can discuss this information with friends or
relatives if you wish. Take time to decide whether
or not you wish to take part.
You are free to decide whether or not to take part
in this research study. If you choose not to take
part, this will not affect the care you get from your
doctors in any way.
You can stop taking part in the study at any time,
without giving a reason.
Ask us if there is anything that is not clear or if you
would like more information.
You will have up to 1 month to consider this
information and to decide whether you want to
participate.
If you decide to take part you will be given a copy
of this information sheet and asked to sign a
consent form. You’ll get a copy of that as well.
Contents
1 Why are we doing this study?
2 Why am I being asked to take
part?
3 What will I need to do if I take
part?
4 What are the possible benefits
of taking part?
5 What are the possible
disadvantages and risks of
taking part?
6 More information about taking
part
7 Contacts for further
information
How to contact us
If you have any questions about
this study, please contact:
Dr Whitney Scott
Health Psychology Section
King’s College London
Guy’s Hospital
5th Floor Bermondsey Wing
Tel: 0207 188 5421
Email: [email protected]
IRAS ID: 205949
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1
Why are we doing this study?
Chronic pain can have a big impact on a
person’s life. It can affect the way people
think and feel and the activities they do.
Unfortunately, medications by themselves
do not always reduce pain. Because of this,
psychological treatments like ‘cognitivebehavioural therapy’ (CBT) are sometimes
also given to people with chronic pain to
help reduce the impact of pain on a person’s
life.
CBT for chronic pain can help people to
learn new ways of dealing with pain. This
type of treatment helps people understand
the relationship between physical pain,
thoughts, feelings, and actions. Treatment
can also help people to focus more on the
present moment when that might be
helpful. CBT also helps people to identify
some goals and to take steps toward their
goals. Research suggests that CBT doesn’t
necessarily change how much pain people
feel, but it can help people cope better with
pain, and improve their mood and level of
functioning with pain.
help people to practice new ways of dealing
with pain. People may also receive email or
telephone support from a therapist as they
complete the online sessions. Recent
research suggests that CBT that is delivered
over the Internet may be helpful for people
with chronic pain.
Unfortunately, there is almost no research
on CBT for people with HIV that have
chronic pain due peripheral neuropathy. As
a result, we don’t know whether this type of
treatment might be helpful for people with
HIV and peripheral neuropathy.
We want to talk to people to see how pain
due to HIV-related peripheral neuropathy
impacts their lives, and how they cope with
pain. We also want to see what people think
about CBT for managing pain due to
peripheral neuropathy. We also want to see
what people think about a version of CBT
that could be delivered over the Internet.
We are hoping to use responses from this
interview study to develop a version of CBT
specifically for people with pain due to HIVrelated peripheral neuropathy.
2
Why am I being asked to
take part?
CBT for chronic pain is usually delivered in a
group program in a hospital by a
psychologist. Unfortunately, not everyone
who needs this type of treatment can get it.
Some people find it difficult to get to the
hospital regularly during the day, and there
is usually a long wait time for this treatment.
Because of this, researchers have been
developing versions of CBT for chronic pain
that are delivered over the Internet.
You are being asked to take part because
you are 18 or older and living with HIV and
chronic pain in both of your feet that is not
due to a cause other than HIV or its
treatment.
Online CBT treatment sessions usually
consist of audio or video clips that give some
information about chronic pain and guide
people through psychological exercises to
Not everyone may be able to take part in
this study. We need to first ask you some
questions to see whether you are eligible to
take part. If your doctor told you about this
study during your appointment, you might
IRAS ID: 205949
Can I definitely take part?
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be asked to speak to Dr Whitney Scott
immediately following your appointment to
see if you are eligible. If you did not speak to
Dr Whitney Scott on the day of your regular
clinic appointment, Dr Scott will contact you
by telephone to see if you are eligible, if you
signed the consent form agreeing to be
contacted. If you heard about the study by
an invitation letter or an advertisement,
please contact Dr Whitney Scott directly to
see if you are eligible.
3
What will I need to do if I
take part?
We will send you a package with a consent
form and questionnaires to complete at
home that will take about 20-30 minutes to
do. These questionnaires will ask you about
some general background information, your
medical history, and some of your current
symptoms.
You will be asked to attend a single
appointment at the Chelsea & Westminster
Hospital campus of Imperial College London
or King’s College London, Guy’s Hospital
(depending on your preference), and
complete an interview that will last
approximately 1 hour.
At the appointment, we will collect the
consent form and questionnaires you
completed at home. If you were not able to
complete the questionnaires before the
appointment, we will ask you to complete
them when you go home and return them to
us.
At the appointment, we will quickly examine
your vibration sensation in your feet and
your ankle reflexes. These tests will be done
to give us more information about your
peripheral neuropathy diagnosis. You will
complete the interview in a private room.
IRAS ID: 205949
The interviewer will ask you questions about
how pain affects your life, how you cope
with pain, and your thoughts on a
psychological treatment for managing pain.
Your interview will be audio recorded.
We may ask you to pass on a recruitment
leaflet to other people you know who might
be interested in participating. It is
completely up to you whether you choose to
pass on this information, and you will still be
able to participate if you choose not to do
this.
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What are the possible
benefits of taking part in
this study?
There may not be any direct benefit to you
for taking part in this study. The
information we get from this study may
help us to improve treatment for future
patients with pain due to HIV-related
peripheral neuropathy.
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What are the possible
disadvantages and risks of
taking part?
We don’t expect this study to have an
impact on your safety or well-being. You
may find some of the questions upsetting to
answer. If you find any of the questions
difficult or upsetting you do not have to
answer them. You can stop the interview
altogether if you want. If you feel upset
because of the study procedures you can
contact Dr Whitney Scott to discuss this
further.
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If we discover any symptoms that cause us
concern for your health or well-being, we
will tell you and we will contact your GP to
co-ordinate further investigation. This is to
make sure that you get the best care
possible.
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More information about
taking part
Do I have to take part in the study?
No, it is up to you to decide whether or not
to take part. If you decide to take part you
will be given this information sheet to keep
and you will be asked to sign a consent form.
A decision to not take part at any time will
not affect the standard of care you receive.
Will I get back any travel costs?
You will receive a £20 voucher to
compensate you for taking the time to
complete the study. You will also receive
travel expenses up to £15. We cannot
reimburse you for travel expenses that are
more than £15.
Can I stop taking part after I’ve joined
the study?
You can stop taking part in this study at any
time. If you want to stop taking part in the
study, it would help us to understand why
you have decided this, so we would like to
ask you about your reasons. It is up to you to
decide if you want to tell us or not, and you
are still free to stop the study without giving
a reason. If you choose to stop taking part,
we will use the data we collected about you
up until the point that you decided to stop
participating, unless you ask us to not use
those data.
IRAS ID: 205949
What will happen to information
about me collected during the study?
All information that is collected about you
during the course of the research will be
kept strictly confidential. We will give you a
unique ID code when you complete the
questionnaires and interview so that your
responses on these are anonymous.
The audio recording of your interview will be
transcribed word-for-word. The audio
recording will be destroyed after it has been
transcribed. Anything that you say during
the interview that reveals your identity will
be removed. We may use direct quotations
from your interview in future presentations
and publications, but your identity will
remain anonymous.
We will send a letter to your GP saying that
you are participating in the study, so that
your GP is aware of this.
All information that is collected about you
will be kept securely at the Chelsea and
Westminster Hospital campus of Imperial
College London Campus, or the Guy’s
Hospital Campus of King’s College London.
We will share anonymous information
collected about you with our colleagues
working on this study from King’s College
London, Imperial College London, and
University College London, as well as two
patient representatives who are helping
with the project. Only researchers directly
involved with this study will have access to
your anonymous data. It may be required
that your anonymised data are reviewed by
King’s College London, our study sponsor, so
they can monitor the conduct of the study.
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Your questionnaire and interview data will
be used solely for the purposes of this study.
These data will be retained for 10 years and
will then be disposed of securely.
On the consent form, we will ask if you are
willing to be contacted in the future to
discuss your potential participation in other
studies about HIV-related peripheral
neuropathy. If you consent to this,
researchers from our team may use your
contact information to send you information
about future studies.
What will happen to the results of the
study?
When the study is completed, we will send
you a summary of the results. We will also
post a summary of the results on the study
website. We will publish the results in a
medical journal and present them at
conferences, so that other researchers can
see them. You can ask the research team for
a copy of any publication. Your identity and
any personal details will be kept
confidential. No named information about
you will be published in any report or
presentation about this study.
Who is organising and funding
the study?
This study is organised King’s College London
and Chelsea and Westminster Hospital NHS
Foundation Trust. The study is funded by the
National Institute for Health Research.
King’s College London has overall
responsibility for the conduct of the study.
King’s College London is responsible for
ensuring the study is carried out ethically
and in the best interests of the study
participants.
IRAS ID: 205949
Who has reviewed the study?
The study has been reviewed by the
National Institute for Health Research. It has
been approved by the NHS research ethics
committee and Chelsea and Westminster
Hospital’s Research and Development
Office. A group of patients living with HIV
also reviewed the study.
What happens if the study stops
early?
Very occasionally a study is stopped early. If
it happens, the reasons will be explained to
you.
What if something goes wrong
for me?
If you have a concern about any aspect of
this study, you should ask to speak to the
researchers who will do their best to answer
your questions [contact: Dr Whitney Scott,
Phone: 020 7188 5421
Email: [email protected]].
In the event that something does go wrong
and you are harmed during the research
then you may have grounds for legal action
for compensation against King’s College
London but you may have to pay your legal
costs. King’s College London maintains
adequate insurance to cover any liabilities
arising from the study.
You can also contact the Chelsea &
Westminster Patient Advice and Liaison
Service if you have concerns about your
treatment in the study (Phone: 020 3315
6727; email: [email protected])
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Contacts for further
information
If you want further information about the
study, contact:
Dr Whitney Scott
Health Psychology Section
King’s College London
5th Floor Bermondsey Wing
Guy’s Hospital
London SE1 9RT
Tel: 020 7188 5421
Email: [email protected]
IRAS ID: 205949
OR
Professor Andrew Rice
Faculty of Medicine, Department of Surgery
and Cancer
Imperial College London
369 Fulham Road
Chelsea and Westminster Hospital
London
Tel: 020 3315 8816
Email: [email protected]
Thank you for taking the time to consider
taking part in this study.
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