STAMPEDE: PATIENT INFORMATION SHEET-GENERAL: PART 2
(to be printed on local hospital headed paper)
Version 10.0 (April 2013)
A LARGE PRINT VERSION IS AVAILABLE ON REQUEST
1. What will happen to the results of this research study, STAMPEDE?
The results will be of interest to a variety of health professionals including medical consultants, nurses and other healthcare professionals as well as, of course, to patients and their families. Our findings will be disseminated through conference presentations and journal articles and through links already existing between the Medical Research Council (MRC), Cancer Research UK, prostate cancer support networks and participating hospital. Your study doctor will be informed of the results and sent a summary of the findings so your study doctor can discuss the results with you. A copy of the results will be freely available to you on request. No individual patients will be identified in such publications. The results of the current questions will not start to be available until around 2017.
2. Will my taking part be kept confidential?
Yes. We will follow guidelines developed by the NHS and legal requirements to make sure that all information about you is treated in confidence. The Medical Research Council Clinical Unit (MRC CTU) is co-ordinating this study and will be collecting information about you, if you decide to take part in this study. As far as is possible, information kept about you is identified by a trial number rather than by name.
The MRC CTU and Medicines and Healthcare products Regulatory Agency (MHRA), the organisation that monitors medical research in the UK, may need to check that the information is correct by reviewing your hospital notes; your confidentiality will be protected at all times.
If you do choose to participate we would like to tell your GP, but only with your permission.
Information held, for example by the NHS, may be used to provide information about your health status after participation in the trial. The MRC CTU is registered under the UK Data Protection Act (DPA) to store this information. There is a question about this on the consent form that we will ask you to sign before you begin the study. We would keep this information separate from other information we collect about you.
3. Further Information
Whichever treatment(s) you receive, the aim is to control your cancer and help you feel well for as long as possible. If your cancer starts to grow despite the treatment or any new information becomes available or you would be better helped by an alternative treatment, your study doctor will discuss this with you. You can withdraw from the trial at anytime and it will not affect your subsequent care in any way. Similarly, your care will not be affected if you do not choose to participate.
More information about clinical trials can be found on the Cancer Research UK's patient website, CancerHelp UK (
If you have private medical insurance, you should check with your company before agreeing to take part in the trial. This will usually not cover you for trial procedures outside of standard practice, which will usually need to be delivered via the NHS. Standard treatments (e.g. radiotherapy) should still be covered by your policy as these are no different to the treatment received off study. Participation in the trial should not affect your subsequent use of your health insurance policy.
Please ask any questions you may have; take time to discuss the trial with your family, friends and GP. If you agree to take part in the trial, you will be asked to sign a consent form.
4. Will I be paid for taking part in the study?
There will be no payments to patients who agree to participate in this trial and additional travel expenses cannot be reimbursed.
5. Will my doctor be paid if I take part in the study?
There will be no payment to your doctor if you choose to participate in the trial. However, the trial is part of the National Cancer Research Network (NRCN) portfolio of trials. This means your doctor will be entitled to research support for the trial (for example, help from a research nurse to run the trial).
Please report any unwanted effects to your cancer doctor or nurse.
If you become unwell between hospital visits, please seek advice immediately, either from your hospital team or from your GP.
6. What if I change my mind about taking part in the study?
If you change your mind about taking part in the study, you can stop your study treatment at any time. This will not affect your relationship with the doctors and nurses, or your subsequent care, in any way. Even then, we would still like to monitor your progress and, if you agree, we would want to continue to collect some information so that the long-term effects of your treatment can be assessed.
7. Who is organising this study?
The Medical Research Council (MRC) has overall responsibility for this trial. The study is funded by a clinical trials grant from the Clinical Trials Advisory and Awards Committee which allocates money from Cancer Research UK. The MRC also supports the trial through its core funding. Some further financial support and drug supplies have been obtained from the pharmaceutical companies: Novartis, Sanofi-Aventis, Pfizer and Janssen. The study has received the favourable opinion of an independent Research Ethics Committee. The trial is run from the MRC Clinical Trials Unit (MRC CTU), London.
8. Who has reviewed this study?
To protect your safety, rights, well-being and dignity, this study has been reviewed by theWest Midlands Research Ethics Committee. This committee has given this research the go-ahead. The research has also been reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA). The science has been reviewed by many organisations, including Cancer Research UK’s funding body for clinical trials. The study has been developed by, and is overseen by, a committee which involves patient representatives.
- What if things go wrong?
The MRC is the sponsor of this trial and as such would give sympathetic consideration to claims for compensation for any non-negligent harm that you may suffer by participating in this trial. The MRC and NHS are both publicly-funded bodies and are not allowed to purchase advance insurance to cover indemnity because they are backed by the resources of the Treasury. Like other publicly funded bodies, any liability arising from the MRC's activities is underwritten by the UK Government. However, this does not extend to harm arising from receiving the ’standard treatment’.
The hospital(s) you are treated in continue to have a duty of care to you, whether or not you agree to participate in this trial. Therefore, the MRC does not accept liability for negligence on the part of employees of hospital. This applies whether the hospital is an NHS Trust or not, and the MRC cannot be held liable for any breach in the hospital’s duty of care. If you wish to complain about any aspect of the way you have been approached or treated during the course of the study, the normal National Health Service complaint mechanisms will be available to you.
- What if new information becomes available?
Sometimes during the course of a clinical trial, new information becomes available about the treatment that is being studied. Throughout the study, medical information from this study and any other studies will be looked at by an independent committee. If any new information becomes available that may affect your participation in this study or would affect your future care, your study doctor will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw, your study doctor will make arrangements for your care to continue. If you decide to continue in the study you would be asked to sign an updated consent form.
For more information, please contact …
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