RAMPART Quality of Life Interview Study
What is the RAMPART Quality of Life Interview Study?
We are inviting some patients who have taken part in RAMPART to take part in a research study looking at patient views on how immunotherapy treatments affect quality of life for patients with kidney cancer.
How do I take part?If you have received information about this study and are looking to sign up and participate, please follow the link below to access the online consent form. This will take you to a web page where you can provide your consent to participate in the study. Consent form for participants taking part in the RAMPART Quality of Life Interview Study If you are unsure how to complete the consent form online you can contact the research team for assistance via email or telephone using the email address and phone number below. If you would prefer to post a consent form please complete the consent form provided and post in the pre-paid envelope using the address below.
Who to contactDr Sophie Merrick - RAMPART Trial Team
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What is this study about?
The purpose of this interview study is to help us understand how immunotherapy affects the quality of life of people with kidney cancer.
The RAMPART Trial is trying to find out whether taking immunotherapy treatments for one year following surgery can prevent or delay kidney cancer coming back compared to the current standard of care (which is active monitoring after surgery).
As well as understanding whether immunotherapy treatments can prevent or delay the return of cancer and what side effects they cause, it is important that we understand their impact on quality of life.
Quality of life is not an easy thing to measure as each of us have different values. We would like to explore in more detail what matters to RAMPART participants when it comes to their Quality of Life.
We hope that this study will help doctors understand what impact immunotherapy has on quality of life. We hope this information will improve the care and support that can be given to people who receive immunotherapy in future.
Why would we like to talk to you?
We are inviting people already taking part in the RAMPART trial who were allocated to receive immunotherapy to take part in this interview study which has been developed by the RAMPART team.
We are interested in hearing about your experiences and your views. There are no right or wrong answers.
What will be involved?
The interview will be a discussion between yourself and one researcher. It will take between 30-90 minutes. You can have a break during the interview if you need to.
During the interview you will be asked questions to check your personal details and then asked for your views on how treatment with immunotherapy has affected your quality of life. You do not have to talk about anything you do not want to talk about.
The interview can be conducted:
• Online
• On the telephone
• In person (if practical)
You can indicate on the consent form how you would prefer to have your interview.
If your interview takes place online this will use a remote video conferencing service through the internet called Microsoft Teams. You do not need to download any software for this. The research team will send you a link to join the interview in advance and you will be able to access this via a normal browser. You will need internet access to take part in an online interview. The research team can give you support to use the software if needed.
If you would prefer not to have your interview online or do not have access to the internet we can also carry out the interview over the telephone or in person if practical. If you are having an interview in person we will discuss with you ahead of time where this will be.
During your interview we will make a recording so we can remember what is said. If the interview is online this will be a video recording. If the interview is on the telephone or in person this will be an audio recording. The recording will be stored in a secure area until all personal details that could identify you have been removed.
Do I have to take part?
No. 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 own doctors in any way.
Will my details be kept confidential?
Yes, your information will be treated in confidence. We will not feedback any of the information discussed in the interview to your cancer team. However if we believe that you or another person is at risk of harm during the interview, confidentiality may be broken and the relevant authorities may be
contacted.
Who are we?
Our team is based at the Medical Research Council Clinical Trials Unit at University College London (UCL). The project lead for this sub study is Dr Sophie Merrick who is a doctor specialising in cancer treatment (oncologist) and is completing her PhD at UCL.
How will my data be stored and collected?
The information you provide in the discussion and your personal details will be kept securely in an encrypted storage area provided by University College London (UCL). Only researchers directly involved in this study will have access to the data. University College London (UCL) is the sponsor for this study based in the United Kingdom. We will be using information from you 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.
We will keep the recording and transcript from the interview for 10 years. 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 more than two weeks after taking part, 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 at:
https://www.mrcctu.ucl.ac.uk/privacy/
In exceptional cases when, during interview, someone tells the researcher about
something that the researcher deems a danger to the individual or someone else, then the researchers’ duty to keep the information confidential can be outweighed by the need to disclose information in the public interest. In these circumstances the researcher may have to contact a relevant medical professional.
What will happen to the results of this study?
We will publish a summary of the results on the RAMPART website:
https://www.rampart-trial.org/
We will publish findings from this study in publications and reports so that anyone who is interested can see them. You can ask us 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 of this study.
Who is funding and organising this study?
This study is organised by the RAMPART trial team. The sub study is being funded by Kidney Cancer UK. This sub study will form part of Dr Sophie Merrick’s PhD thesis which is funded by the Medical Research Council. University College London is the sponsor for this study and has overall responsibility for its conduct. University College London is responsible for ensuring the study is carried out ethically and in the best interests of study participants.
Who has reviewed this project?
Patient representatives have been involved in the design and management of this study and
also in writing this information. This project has received ethical approval from London Riverside Research Ethics Committee.
If you wish to complain or have any concerns about any aspects of the way you have been approached or treated by members of the research team while taking part in the study, please email Dr Angela Meade at: a.meade@ucl.ac.uk.
For further information about the RAMPART Quality of Life interview study, please click the link below to access the Participant Information Sheet.
RAMPART Quality of Life Interview Study Participant Information Sheet v1.0