Novel consent process for research in dying patients unable to give consent

A randomised study to compare the effectiveness of Hyoscine hydrobromide (Hyoscine) and Glycopyrronium (Robinul) in the management of retained secretions / noisy breathing in cancer patients.

Patient Information

Protocol No 2049

We would like you to consider participating in a trial in the future to assess the use of two drugs for the treatment of retained secretions / noisy breathing.

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 friends, relatives and 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 would wish to take part if you were to develop retained secretions in the future. If you do not wish to participate in the study, please discuss this with your doctor as there are other treatments available for the treatment of retained secretions which may be suitable for you to take. Thank you for reading this.

Patients with advanced cancer often develop a number of symptoms including pain, nausea, restlessness and difficulty in swallowing. We are continually trying to improve our management of such symptoms. One of the ways or ensuring that we are improving our patients care and symptom control is to undertake research in the area to identify best practice and which drugs are the most effective.

We are asking patients who are under our care on either Chevallier or Horder wards if they would consider taking part in a study in the future.

What is the purpose of the study?

When patients are very ill and too weak to cough properly, they sometimes find it difficult to clear fluid from the large airways. This can result in noisy breathing, and can be problematic. The purpose of this study is to compare the effectiveness of two drugs used routinely to control this symptom, in order to ensure that we are giving the best care possible to our patients. The two drugs we use to try and control noisy breathing work by drying up secretions that have built up in the large airways in the lungs.

Why am I being invited to take part?

We are asking you to consider taking part in our study for a symptom which you may or may not develop in the future because there may come a time when you are not well enough to read/understand this information and would be unable to give written consent to participate.

We are asking all our patients who are under our care on either Chevallier or Horder ward to consent to enter this study well before we anticipate you may or may not develop retained secretions and noisy breathing.

What will happen to me if I take part, and what will I have to do?

If you agree to take part in this study, we will ask you to sign a consent form. In the event of you developing this symptom in the future you will be randomly allocated to receive one of two drugs for the control of noisy breathing, Which treatment you are given will be decided by a process called randomisation i.e "randomly" like the toss of a coin. Each time you are an in-patient on our ward you will be asked if you are still willing to enter our study and will be asked to re-sign your consent form.

If you were to develop noisy breathing while a patient on our ward, we would firstly help you lie in a different position to see if this helps. If you still have noisy breathing after 30 minutes we would give you a small injection of either a drug called hyoscine hydrobromide or glycopyrronium to try and dry up the retained secretions which are causing the noisy breathing. Your nurse will be continually assessing you to see if the drug has made your noisy breathing any better. You will be given up to two injections of the drug and if they are assessed as being helpful by your nurse we will give you it regularly in the form of a continual subcutaneous infusion. (i.e. you will receive the medication continually through a small needle in your arm, which should not cause any discomfort). Your nurses will be assessing your noisy breathing regularly to see if our medications are working.

What are the possible side effects?

Both hyoscine hydrobromide and glycopyrronium have been used for many years in clinical practice and are known to be effective and both are safe to use. As with all medications there are some side effects associated with each drug. The side effects sometimes seen with glycopyrronium are: dry mouth and possibly an increase in your heart rate. The side effects sometimes seen with hyoscine hydrobromide are: drowsiness, dry mouth, blurred vision and occasionally confusion. Your doctors and nurses will be assessing you at all times and would stop any treatment if they thought it was giving you any unwanted side effects.

What happens when the research study stops?

When the research study stops we will gather all the information we have collected about the two treatments and will analyse the results. We would then plan to publish the results so that patients in other palliative care centres can gain benefit from our work. Details about all the patients involved in this study is kept anonymous in any publications.

Who is organising and funding the research?

This study is being initiated and conducted by the RMH and approximately 250 patients will be included in the study.

Who do I contact if I have any questions?

If, at any time following agreeing to take part in this study you are concerned about any aspect of the trial you should contact any of the staff as listed below and they can discuss any aspect of the study with you. There will always be someone available to talk to you any time of the day or night

What if I change my mind?

Your participation in this study is entirely voluntary. If you decide to take part, you may change your mind or withdraw at any time and this will not affect your future treatment or care in any way.

Will my taking part in the study be kept confidential?

All records kept about you for the purpose of the study will be kept strictly confidential and your name will not be disclosed outside the hospital. With your permission, your G.P. will be informed about the study and that you are participating in it. Your right to take legal action in the event of any injury or damage arising out of this study will in no way be affected by your giving consent to participate.

If you have any problems of feel you would like to know any more, please do not hesitate to contact either:

If you are a patient at Sutton: Dr Janet Hardy 020 8661 3182 or Elizabeth Rees / Ali Kennett (Research nurses) 020 8661 3184. Out of hours, contact Chevallier Ward 020 8661 3179.

If you are a patient at Fulham Rd: Dr Broadley / Dr Riley 020 7808 2761 or Bridget Gwilliam (Research Nurse) 020 7808 2681. Out of hours, contact Horder Ward 020 7808 2387.

Date Given to Patient______________________