21st July 2023
Please see below for the COLO-SPIRIT participation information for health professionals
COLO-SPIRIT is a new study led by Newcastle University’s Centre for Cancer. This is a qualitative study comprising interviews with patients and health professionals.
The aim of the study is to better understand the needs of patients with chronic bowel problems following pelvic radiotherapy. These patients may present with symptoms including bleeding, incontinence, diarrhoea, tenesmus, pain and urgency. The impact on patients’ quality-of-life is likely to be substantial. A major challenge of the condition is the lack of good management options. Little has been documented regarding the needs of these patients or the challenge faced by health professionals trying to support these needs.
The sponsor is South Tyneside and Sunderland NHS Foundation Trust. The funder is 3-D Matrix, a company that produces a haemostatic agent which may have a role in promoting bowel recovery. Funding was awarded following a competitive process and internal review.
Why have we contacted you?
We plan to interview; patients who have received pelvic radiotherapy and are experiencing chronic bowel problems, and health professionals from a variety of specialisms who may encounter these patients in their practice (e.g. GPs, oncologists, cancer specialist nurses, therapeutic radiographers). You have been contacted because you may encounter these patients in your practice.
What does participation entail?
If you choose to take part, a member of the study team may contact you to arrange an interview. Interviews will be conducted either in-person or remotely (by phone or video conferencing). Interviews will last approximately 1 hour and will be arranged for a time and place convenient to you. Interviews will be audio recorded. The study will work with anonymised transcripts of interviews.
You do not have to take part in this study. There are no negative consequences for declining to take part, nor are there likely to be any direct personal benefits for participating.
How to take part:
If you are interested in taking part in this study please email your preferred contact details to firstname.lastname@example.org and one of the research team will get back to you.
If you have questions about the study, please contact the study coordinator, Adam Biran, at email@example.com.
Thank you for considering participation in this study.
If we do not hear from you, we may try to contact you once more to check that you received this information.
How will the data be handled to protect your privacy?
Your interview will be audio recorded. Immediately after the interview, the interviewer will upload the audio recording to a secure server at Newcastle University, and delete it from the digital Dictaphone (recorder). The audio file will be labelled with your anonymous participant number and no personally identifiable details will be attached to this file. The audio file will be encrypted and sent to a transcription service. We will (separately) provide the transcription service with a password to open the file. The transcription service will not be provided with any of your personal information.
The typed-up version of the interview (transcript) will be anonymised. This means it will not contain your name, or any personally identifiable details about yourself, or anyone else you referred to in the interview. The anonymised interview transcript will also be uploaded to a secure server at Newcastle University server. Only the research team will have access to it.
You have the option to give your consent for future research studies to request access to your anonymised interview transcript for the purposes of their research. This is optional. If you do consent to this, all requests to access your interview data will have to be approved first by the COLO-SPIRIT research team. We will look at the reasons why the researchers want to see your transcript, what they will do with it, and what the goal of their research is. Any studies that we believe are of a high quality, and from which scientific advances can be made by analysing the data, will be allowed restricted access. We will provide them with the anonymous transcript and minimal information about you (such as your age and gender), so that they have some context about the person being interviewed, but cannot identify you.
Data will be stored on Newcastle University secure servers and only the immediate research team will have access to these files, either on the university campus or through Windows Virtual Desktop. Windows Virtual Desktop gives secure access to Newcastle University software and university files outside of university campus. This allows staff to access files remotely if necessary. It is a password protected service that can only be accessed through a university log in and password.
Anonymised transcripts that support publications will be made available at point of publication and will be archived with supporting documentation in data.ncl (https://data.ncl.ac.uk/), Newcastle’s Open Research Data Repository. All other data of long-term value, including audio files which it is not possible to completely anonymise, will be made available within 2 years of project close. It is impossible to completely anonymise audio files, as features of your voice are present. It is highly unlikely that anyone listening to the anonymised audio will be able to identify you. To minimise the likelihood of this happening, in any instances where you present any facts about your life (for instance, village of residence, employer and details of the post), we will remove those elements of the interview before storing the interview.
The datasets will be made public under a Creative Commons licence to ensure credit is given when the data are reused and access is provided for at least five years. Data deposited will
be assigned a persistent identifier (i.e. DOI) that can be included in project outputs, including publications, to detail how and where the data can be accessed.
South Tyneside and Sunderland NHS Foundation Trust is the sponsor and is based in the United Kingdom. South Tyneside and Sunderland NHS Foundation Trust is the data controller for this study and will be using information from you to undertake this study. This means that South Tyneside and Sunderland NHS Foundation Trust is responsible for looking after your information and using it properly. When the Trust uses personally-identifiable information from people who have agreed to take part in the research, we ensure that it is in the public interest. Your rights to access, change or move your information is limited, as South Tyneside and Sunderland NHS Foundation Trust need to manage your records in specific ways for the research to be reliable. This means that you won’t be able to see or change the data collected about you. If you wish to withdraw from the study, South Tyneside and Sunderland NHS Foundation Trust will keep information about you that has already been collected. To safeguard your rights, the minimum personally-identifiable information will be used.
You can find out more about how South Tyneside and Sunderland NHS Foundation Trust uses your information at https://www.hra.nhs.uk/information-about-patients/ and/or contacting South Tyneside and Sunderland NHS Foundation Trust Data Protection Officer (firstname.lastname@example.org).
Your personal contact information will be held by the study team for 6-12 months after the study has ended, in case we need to contact you for any reason, or should you tell us you would like to receive a summary of the study results. After this period, all personal data will be permanently deleted and destroyed. Anonymised audio files and transcripts will be kept on a secure Newcastle University server, which only the research team will have access to. These will be stored securely within the research department for five years after the study has ended. After this period all data, stored within the research department will be permanently deleted and destroyed. Anonymised audio files and transcripts will be archived in Newcastle’s Open Data Repository and made available under the Creative Commons licence for at least five years.
21st July 2023