‘KeepYouSafe’ aims to examine whether patients safety can be improved by giving patients and their carers access to checklists for complications of cancer.
What is the purpose of the ‘KeepYouSafe’?
Modern treatments of cancer save many lives but are often associated with complications. Many of these complications are predictable and some are preventable.
In order to help patient and their carers to keep safe during the challenging times of cancer treatment we intend to develop and test a smart-phone application that encourages regular checks for important complications helping patients and their carers to take the right steps if these occur.
Testing will include questionnaires about your experience, evaluating the number of times that the app has been used. We will also collect information about what other support you have accessed in hospital or with your General Practitioner within 60 days of starting to use the application.
Why have I been invited?
You are being invited because you are having treatment for cancer.
Do I have to take part?
It is up to you to decide whether you want to take part. You are free to withdraw at any time, without giving a reason. This will not affect the care you receive.
What will I have to do?
You will be asked to use a smart phone application. The smart phone applications will ask you once or twice per day whether you are feeling ok. Depending on your answer it will ask you a small number of further questions. If those questions show symptoms that could indicate more serious problems then the application will give you the telephone number of the relevant helpline and ask you to consider a call.
The application will NOT immediately alert someone but the results of your answers will be shared with your oncology team. They will review the results in the morning between 8:00 and 11:00.
Additionally we would be grateful if you could active the function in the application that allows you to share the results with at least one member of your family or a friend. They would receive a notification if your answers to the application indicate that you are feeling unwell or if you stop unexpectedly to interact with the application.
During the course of the study you will be asked to fill in a small number of questionnaires about your recent health and how you feel. Some of the questions might be just simple lists where you tick one of several possibilities. The questionnaires will take about 30 minutes and a research nurse or medical student will help you with them. The questionnaires will be asked at the beginning of the study and again after one month and two months.
You will be offered to use the application initially for up to 60 days. You are free to stop using the application at any time without asking for permission. Usage might be possible after the study period.
Expenses and payments?
There are no payments for taking part in this study.
What are the possible disadvantages and risks of taking part?
You might feel inconvenienced by spending time answering the questions. To our best knowledge there are no risks in taking part.
What are the possible benefits of taking part?
We cannot promise the study will help you but the information we get from the study is likely to helps us to design and test better care for future patients.
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to the researchers or the hospital concerns team who will do their best to answer your questions (Concerns office, telephone 01248-384 194).
In case of accidental disclosure of confidential details you will be informed and the disclosure will be reported in line with Standard Operating Procedures of BCUHB.
Is there any other way that I can help this research even if I don’t want to use the application?
You could still help us with this research by answering the same questionnaires as the patients that use the app. This would really help us to compare your experience with the experience of the patients using the application.
Will my taking part in the study be kept confidential?
For the study we will ask you a few questions. One copy of the answers to those questions will be added to your hospital notes and might help your doctors and nurses to look after you. All information which is collected about you during the course of the research will be kept strictly confidential. Any quotes from you will be anonymized.
Any information about you that is not in the hospital notes will have your name, address and any other personal details removed so that you cannot be recognized. Your confidentiality will be safeguarded during and after the study by the Caldicott principles and/or Data Protection Act 1998. All identifiable information will be deleted three months after the completion of the study.
We would like to let your GP know that you are taking part in this study.
What will happen if I don’t carry on with the study?
If you withdraw from the study all the information and data collected from you, to date, will be destroyed and your name removed from all the study files.
What will happen to the results of the research study?
The results of the study will be published in medical journals. You will not be identified in any report/publication. Results will also be published in a blog (https://audiblepatientvoiceblogg.wordpress.com/author/csubbe/) where you can access them.
Who is organizing or sponsoring the research?
The study is organized by local doctors and nurses and supported by specialists in cancer care from Coventry and The Christie Hospital as well as medical students from Cardiff University who are training in Bangor. The study is funded by the cancer charity Tenovus.
Betsi Cadwaladr University Health Board is the sponsor for this study based in Wales, the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Betsi Cadwaladr University Health Board will keep identifiable information about you for three years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting our Information Governance Department 01978 727689. You can find out more about how patient information is used in health and care research from the Health Research Authority at www.hra.nhs.uk/information-about-patients.
The NHS will collect information from you and your medical records for this research study in accordance with our instructions.
The NHS research team will use your name, NHS number, or other hospital identifier and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Betsi Cadwaladr University Health Board and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The NHS research team will pass these details to Betsi Cadwaladr University Health Board along with the information collected from you and your medical records. The only people in Betsi Cadwaladr University Health Board who will have access to information that identifies you will be people who need to contact you to for the purposes of the research or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number, hospital identifier or contact details.
The NHS research team will keep identifiable information about you from this study for approximately three months after the study has finished.
Further information and contact details:
We hope that you are interested in working with us on this important project.
For more information please don’t hesitate to e-mail us on Christian.Subbe@Wales.NHS.UK.
We ask you for your permission to participate in the questionnaires and the review of your medical information.
You are free to stop participating at any time and without giving any reason to withdraw your permission. This has no negative consequences for your treatment.
If, after reading these notes questions remain unanswered, please send them directly to Christian.Subbe@wales.nhs.uk.