The effects of chemotherapy for breast cancer on managing daily tasks - Recruitment & Treatment

 

We would like to invite you to take part in our research project. The research team is based at Loughborough University.

Please read this information sheet carefully. It is important that you understand why the research is being done and what is involved should you wish to take part. If you have any questions or comments please contact the researcher – contact details are at the end of this sheet. You may also wish to talk to a family member or a friend about the study. Please take time to consider whether or not you wish to take part.

• What is the purpose of the study?
We are interested in looking at the effect chemotherapy treatment has on breast cancer patients’ ability to think, concentrate and remember. Problems with these abilities may have an influence on oversights, lapses and absent-mindedness experienced during daily activities. This might include looking for your glasses then realising you’re already wearing them, or injuring yourself during a fall. ‘Human error’ as a result of treatment may have an impact on typical activities at home, during leisure activities or at work. For some patients, maintaining or returning to their typical daily activities during and after treatment is an important step on the road to recovery. As more women are surviving cancer, understanding the impact of treatment is an important issue not only for patients, but also for healthcare professionals, employers, friends and family members who can offer support and guidance during and after treatment.

We are recruiting breast cancer patients about to undergo chemotherapy treatment and also those about to undergo radiotherapy treatment who will act as a comparison group. This will enable us to better understand any effects of chemotherapy treatment more clearly. We will also be recruiting participants with no history of cancer to act as a control group.

This study, which is part of a Ph.D. research project, will give the opportunity for breast cancer patients to provide valuable insight into the effects of cancer treatment. This information will be used to inform others so that the experiences of breast cancer patients are better understood. In time, we hope this will lead to intervention and rehabilitation programmes that support cancer patients coping with the side effects of cancer and treatment. Improved guidance for employers could also be developed.

There are 2 parts to this study. Firstly, we would like to invite you to answer 4 postal questionnaires. Secondly, there is also the option to keep a diary on a cassette-tape. You can take part in both or just the questionnaire if you wish.

• Who is doing this research and why?
This study is part of a Ph.D. project by research student Miss Catherine Lawrence. Her academic supervisors are Dr Hilary McDermott and Dr Fehmidah Munir.

• Who can take part?
We are recruiting participants who meet the following criteria:
o Women over 18 years old
o Have been diagnosed with breast cancer
o Will undergo chemotherapy or radiotherapy treatment
o Can read and write standard English

• What will happen to me if I take part?
If you decide to take part then you will first need to contact Catherine to express your interest in the study. Please take time to come to a decision and ask the researcher any questions you have. You will be asked to answer a brief recruitment and treatment questionnaire either by telephone or via post to make sure that you meet the criteria to take part. You will then be asked to sign the Consent Form if you are happy to do so. Two copies of the signed Consent Form will be made: one for you and one for the researcher.

Questionnaire
The study involves answering a questionnaire which will be posted to your address on four occasions (Time 1: before you start treatment; Time 2: four months later; Time 3: eight months later, and Time 4: twelve months later). The questionnaire asks about your general feelings, memory and concentration. It will take about 30 minutes to complete and you can return it in the pre-paid envelope within a week.

Audio-diary
It is up to you if you wish to keep a diary as well as answering the questionnaire. This part involves taking a hand-held audio tape-recorder home with you. You will be asked to keep a diary for 4 months to record any incidences when you notice that you experience absent-mindedness. This might include forgetting to buy something from the supermarket, sending an email to the wrong person or a physical fall. Each entry need only be a couple of minutes. We are interested in what errors you might make during typical activities, no matter how big or small.

• How long will it take?
If you agree to take part then you will be involved in the study or 12 months. This involves answering a questionnaire soon after you sign the Consent Form. Then 4 months later, 8 months later and 12 months later. This means that over 12 months we ask that you give us about 2 hours of your time. This may be more if you wish to also keep an audio-diary.

• What are the possible disadvantages and risks of taking part?
The questionnaire should not cause you any discomfort or distress. You should only participate if you feel comfortable doing so. The researcher will contact you at the start to outline the project and answer any questions you have. If you attend a local support group then the researcher could meet with you at a group meeting; visit you in your home, or you could visit Loughborough University if necessary, e.g. to give you a tape-recorder. Please note that we cannot reimburse travelling expenses.

Please be aware that the researcher is not a clinician or a breast cancer nurse. We advise that you contact your GP, a member of your cancer team, or your local support groups should you feel distressed, for whatever reason, at any point.


• What are the possible benefits of taking part?
There will be no direct immediate benefit to you. Your participation will give an insight into the effects of cancer treatment which will provide valuable information about the experiences of breast cancer patients. This will enable better information to be available to cancer patients, healthcare professionals, employers and the general public. In time, we hope that intervention and rehabilitation programmes will be designed to support cancer patients coping with treatment side effects. Guidance could also be developed for employers and others. You will receive a summary of our findings, which will be available approximately one year after the end of the study.

• Will my taking part in the study be kept confidential?
Your identity will be protected by allocating a number to this information and your completed questionnaires. This will be stored with your contact details in a locked filing cabinet at Loughborough University. All information you provide will be kept strictly confidential and will only be accessible by the research team.

Electronic data will be stored securely on a computer at Loughborough University. This information will only be accessible by a password known only to the research team. The procedure for handling, processing, storage and destruction of your data will be compliant with the Data Protection Act 1998.

All reported data, that is anything written up about the study, will be made anonymous so that you cannot be identified. If you decide to take part in keeping an audio-diary, then your entries will be typed up and stored securely on a computer at Loughborough University. Again, your allocated number, instead of your name, will be used. Extracts from diary entries may be reported in publications, but all quotations will be made anonymous so that you cannot be indentified.

• What happens if I don’t want to carry on with the study?
It is your decision to volunteer to participate in the study. If you are interested and sign the Consent Form, you can still withdraw from the study at any time up to the point of publication. No reason is necessary. Please contact the researcher if you wish to withdraw. Once you have withdrawn you will not be asked to answer any more questionnaires. If you are keeping an audio-diary then we will ask you to return the tape-recorder. You will be asked if you want any completed questionnaires and audio-diary entries to be discarded from the study. Previous information, although unfinished, may still benefit our research. We will shred questionnaires you have returned and delete any audio-tape recordings if you wish.

• What if I am not happy with how the research was conducted?
If you have any concerns about any aspect of the study then please contact the researcher. If you remain unhappy and wish to complain formally then please contact Meredith Coney, Loughborough University’s Research Ethics Committee Secretary (Tel: 01509 22 2468; Email: m.r.coney@lboro.ac.uk). The University has a policy relating to Research Misconduct and Whistle Blowing which is available online at www.lboro.ac.uk/admin/ committees/ethical/Whistleblowing(2).htm

• What will happen to the results of the research study?
This research is part of a Ph.D. project. We will summarise the data and anonymous data will be reported in academic journals and at conferences. This enables the sharing of information between researchers, filling the gap of knowledge and allows others to learn from the data. We will send you details of publications if you wish. You will be sent a summary of the findings once all results have been analysed.

• Who has reviewed the study?
This research project has been approved by Loughborough University’s Ethical Advisory Committee and the NHS Research Ethics Committee.

• What if I have any questions or concerns?
If you have any questions or comments, or wish to express your interest in taking part, please contact the researcher:

Researcher:
Miss Catherine Lawrence, B.Sc. M.Sc.
S.S.E.H.S.
Wavy Top Building
Loughborough University
Loughborough
Leicestershire LE11 3TU
Tel: 01509 228151
Email: C.L.Lawrence@lboro.ac.uk

Supervisors:
Dr H. McDermott & Dr F. Munir
S.S.E.H.S.
Wavy Top Building
Loughborough University
Loughborough
Leicestershire LE11 3TU
Tel: 01509 223098 or 01509 228228
Email: H.J.McDermott@lboro.ac.uk or F.Munir@lboro.ac.uk

Thank you for taking the time to read this information sheet and for considering taking part in the study.