INFORMATION SHEET

The role of risk of recurrence, bowel function and avoidance of a permanent stoma in patient preferences for treatment for rectal cancer.

Name and Contact Details of the Principal Researcher: Dr Anne Miles, Department of Psychological Sciences, Birkbeck University of London, Malet Street, London WC1E 7HX. email: ae.miles@bbk.ac.uk; Tel: +44 (0)20 7631 6488. If you want to telephone, please leave a message and your contact details so I can return your call.

Before you decide to take part in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish. A member of the research team can be contacted if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

1. What is the project’s purpose?

Decisions about how to treat rectal cancer can be difficult and complex for both the patient and the medical team. This research aims to find out which factors are most important to people in making a decision about treatment for rectal cancer: reducing their risk of recurrence, avoiding a permanent stoma, having good bowel function. This research will also be able to see what level of (poor) bowel function people will put up with in order to avoid needing a permanent stoma and whether this varies by age, gender or disease stage at diagnosis.

2. Confidentiality

If you decide to take part in the research, all the information you give the researchers through your participation in the research will be held in strict confidence. Only the research team will have access to it. The data you provide will not be passed back to your GP.

You can withdraw the information you give in this questionnaire up to the point at which you press the ‘submit’ button after completing the online questionnaire.

Personal data will not be collected. All data will be fully anonymised data and stored in electronic format for at least 20 years in line with the Medical Research Council Regulatory Support Centre Retention framework for research data and records policy as the data relates to population health and clinical studies.
https://mrc.ukri.org/documents/pdf/retention-framework-for-research-data-and-records/.

3. Why have I been chosen?

We are asking approximately 2000 people including yourself who have been diagnosed with rectal cancer in the UK. The inclusion criteria are: a diagnosis of non-metastatic rectal cancer and ability to read and speak English. The exclusion criteria are: terminal illness, learning difficulties.

4. Do I have to take part?

It is up to you to decide whether or not to take part.  If you do decide to take part please complete the questionnaire which follows. You can withdraw at any time before you press the ‘submit’ button without giving a reason and without it affecting any benefits that you are entitled to.

5. What will happen to me if I take part?

This study will involve answering questions about your treatment and treatment preferences, as well as questions about you, your health and your mood.  You will be asked to provide written consent by clicking next to boxes on the next page of this website. It is expected that the questionnaire will take about 30-40 minutes to complete. Once you have completed the questionnaire you will not be required to do anything further. We will not contact you again in relation to this study. You can decide to withdraw from the study at any time. The latest point at which you can be removed from the study is any time up until you press the ‘submit’ button at the end of the online questionnaire.

6. What are the possible disadvantages and risks of taking part?

Participation in this study involves answering questions about your experience of having cancer diagnosed and treated; what you think about your treatment and what it has been like to live with any treatment-related side-effects, as well as questions about you, your health and your mood. There is a chance you could find these questions distressing. If you do become distressed during the research you can stop participating and contact the sources of support which are listed at the bottom of this information sheet.

7. What are the possible benefits of taking part?

There are no immediate benefits for those people participating in the project, but it is hoped that this work will help inform patient and medical staff decision making around treatments for rectal cancer that take account of the things patients value most highly.

8. Limits to confidentiality

Please note that assurances on confidentiality will be strictly adhered to unless evidence of wrongdoing or potential harm is uncovered.  In such cases the University may be obliged to contact relevant statutory bodies/agencies.

9. What will happen to the results of the research project?

The results of this study will be submitted for publication in a medical journal in approximately 2-3 years. You will not be identifiable in any report or publication.

The data collected during the course of the project might be used for additional or subsequent research. Any data shared in this way will be fully anonymised and no one will be able to identify you when this data is shared.

Personal data will not be collected.

The anonymised data will be stored in electronic format for at least 20 years in line with the Medical Research Council Regulatory Support Centre Retention framework for research data and records policy as the data relates to population health and clinical studies.
https://mrc.ukri.org/documents/pdf/retention-framework-for-research-data-and-records/.
Other authenticated researchers may have access to the anonymised data for the purposes of research or research training.

 10. Who is organising and funding the research?

This research is being carried out by Anne Miles. She is responsible for organizing the study. It is intended that the results of the research will be published in a medical journal in about 2-3 years time. We would like to point out that no volunteers included in the research will be able to be identified from any report or publication.
This study has been reviewed and awarded funding by the Bowel Disease Research Foundation, which is a charity that funds research into bowel diseases.
This study has been reviewed and given ethical approval by Birkbeck Research Ethics committee.

11.   Contact for further information

If you would like to keep a copy of this information sheet for your records, please contact Anne Miles.

The contact details for the Chief Investigator of this study (Dr Anne Miles) are given at the top of the information sheet.

INVOLVE are a national advisory group, funded by the National Institute for Health Research (NIHR), who support and promote active public involvement in NHS, public health and social care research. They publish a Public Information Pack (PIP) for members of the public about getting involved in research which can be obtained from:

INVOLVE
Wessex House
Upper Market Street
Eastleigh
Hampshire
SO50 9FD

Tel: 02380 651088

For information about Birkbeck’s data protection policy please visit:
http://www.bbk.ac.uk/about-us/policies/privacy#7

If you have concerns about this study, please contact the School’s Ethics Officer at: ethics@psychology.bbk.ac.uk

School Research Officer
School of Science, Department of Psychological Sciences
Birkbeck, University of London
London WC1E 7HX

You also have the right to submit a complaint to the Information Commissioner’s Office
https://ico.org.uk/

Macmillan Cancer Support are an independent organisation providing support and counselling to help people live with cancer. They can be contacted at:
http://www.macmillan.org.uk/Aboutus/ContactUs/ContactUs.aspx

Cancerhelp (Cancer Research UK) who provide all aspects of information for people with cancer. Their contact details are:
Tel: 020 7061 8355
Freephone: 0808 800 1234
Or visit their website at http://www.cancerhelp.org.uk

Thank you for reading this information sheet and for considering to take part in this research study.