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Participant Information Sheet We are inviting you to take part in a research study called the OPEN Study: Pain management treatment needs interviews 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 Participant Information Sheet Version 3.0; 16/08/2016 1 of 6 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? Participant Information Sheet Version 3.0; 16/08/2016 2 of 6 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. 4 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. 5 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. Participant Information Sheet Version 3.0; 16/08/2016 3 of 6 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. 6 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. Participant Information Sheet Version 3.0; 16/08/2016 4 of 6 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]) Participant Information Sheet Version 3.0; 16/08/2016 5 of 6 7 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. Participant Information Sheet Version 3.0; 16/08/2016 6 of 6