SO ACTIVE: Exploring significant other experiences of undergoing ACTIVE surveillance for prostate cancer.
To take part in this study your significant other must also be willing to take part. Your significant other can be your partner, or a close relative or friend, but needs to be the person in whom you are most likely to confide about your prostate cancer.
Who is running this study?
SO ACTIVE is being run by a team of researchers at The University of Southampton. The Chief Investigator is Stephanie Hughes, a Researcher at The University of Southampton.
Do I have to take part?
Participation in the project is entirely voluntary. It is up to you to decide whether to take part. You are able to withdraw at any time without giving a reason. If you decide to withdraw or not to take part in this study this will not affect the standard of care you or your significant other receive.
Why is this study being done?
We currently have very little understanding of the role that close interpersonal relationships might have for people undergoing active surveillance for prostate cancer. We are interested in how you and your significant other feel about this diagnosis and treatment plan, and how it impacts on your life. We hope this will give us an understanding of what might be helpful for others in this situation in the future.
What is the background to SO ACTIVE?
The same group of researchers previously carried out a study called PRO-ACTIVE (PROstate cancer support intervention for ACTIVE surveillance). PRO-ACTIVE was a study designed to test a support programme specifically for prostate cancer patients being managed with active surveillance. Results from this study highlighted the importance of the significant other whilst undergoing active surveillance. SO ACTIVE will explore this further.
What will happen to me if I take part?
If you decide you would like to take part you have two options:
1. Continue with this survey, and complete it online.
2. Contact the study team (details below) to be posted a paper version of this survey.
A sub-section of participants will be contacted and asked to take part in a telephone interview.
If you are asked, and agree to take part in the interview, we would prefer you to be alone, and able to speak freely to the interviewer on the telephone. This is because we would like you to be able to talk as openly and freely as possible. If for any reason this is not possible, we would ask you to inform the person conducting the interview that somebody is with you, and who that person is.
Are there any risks involved in participating?
There exists a potential risk that private information gathered during the interview process may be identifiable. To minimize the risk of releasing sensitive personal or family information, we have developed strict guidelines to protect privacy of medical and personal information.
Sometimes talking about your experiences during the interview process may bring about feelings of sadness, anger, or anxiety. If talking or thinking about your experiences makes you unusually anxious, or if any part of the study process causes any bad feelings for you, you will be offered a referral to your GP who will be able to help you manage your distress. You will also be signposted to charities which offer support, such as Macmillan and Prostate Cancer UK. However, if at any time you find the interview distressing, you are free to decline to answer any questions or to terminate the interview immediately and indefinitely.
What are the possible disadvantages of taking part?
There are no known disadvantages in taking part in this study.
What are the possible benefits of taking part?
If you agree to take part in this study there may or may not be direct benefits to you. However, we hope that the information learnt through this study will benefit other prostate cancer patients and their significant others’ in the future.
What if something goes wrong?
If you have any concerns or complaints about any aspects of how this research has been conducted by the researcher then please contact the Research Integrity and Governance Office, Room 4079, Highfield, Southampton, SO17 1BJ. Telephone: 023 8059 8848/9 or email: rgoinfo@soton.ac.uk
Will my participation be confidential?
All information that you provide will be strictly confidential. You will be identified by an ID number and the information you provide will be stored in locked filing cabinets or a password protected computer. The study will fully comply with the Data Protection Act and University policy on conducting research studies. All data will be stored in accordance with research governance for 10 years.
What will happen to the results of the research study?
The results of the research will be published in a medical book or journal and used for teaching purposes. When the study is completed, there will be copies of the published results available from Stephanie Hughes (sh3r11@soton.ac.uk). Please note that neither your name nor any identifying information will be used in any publication or teaching materials without your specific permission.
Who is organising and funding the research?
The research is being funded and organised by the University of Southampton and Southampton University Hospital Trust (SUHT).
Who has reviewed this study?
This research has been reviewed and given a favourable ethical opinion for conduct by The University of Southampton Ethics Committee.
Contact for further information
If you have any questions regarding your rights as a participant in the SO ACTIVE study and/or concerns about the study, or if you feel under any pressure to enrol or continue to participate in this study, you may contact the study team at any time:
SO ACTIVE Chief Investigator: sh3r11@soton.ac.uk / 023 8059 1787 (Stephanie Hughes)
SO ACTIVE Principle Investigator: h.a.everitt@soton.ac.uk / 02380 241 052 (Dr Hazel Everitt)
Thank you again for reading this information and for considering participation in this study.
