Participant Information Sheet/Consent Form
Feasibility of an online mindfulness-based program for patients with melanoma
Online mindfulness – Pilot RCT
Dr Donna Milne
Peter MacCallum Cancer Centre
Part 1: What does my participation involve?
You are invited to take part in this research project, because you have received treatment for melanoma. This research project is testing an online mindfulness-based program for people who have completed their treatment.
This Participant Information Sheet/Consent Form tells you about the research project. It explains the procedures involved. Knowing what is involved will help you decide if you want to take part in the research.
Please read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or healthcare worker.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You will receive the best possible care whether or not you take part.
If you decide you want to take part in the research project, you will be asked to sign the consent section. By signing it you are telling us that you:
• Understand what you have read
• Consent to take part in the research project
• Consent to have the tests and treatments that are described
• Consent to the use of your personal and health information as described.
You will be given a copy of this Participant Information and Consent Form to keep.
2 . What is the purpose of this research?
Following treatment for melanoma, many people feel anxious and scared about the cancer coming back. This is one of the most common fear of cancer survivors, and it can affect people’s ability to enjoy life and plan for the future. In some people this fear can decrease over time, but most people find that they worry at certain times, such as before a follow-up appointment, the anniversary of the date they have been diagnosed or finished their treatment, or hearing/ reading stories about cancer in the news. The mindfulness program aims to help melanoma survivors to manage their fears and worries once treatment is completed.
Research has shown that mindfulness-based programs can help people cope with anxious thoughts about their cancer. The internet would allow people to use the program from the comfort of their home, and at their most convenient times. When we asked people coming to the melanoma clinic if they would be interested to participate in an online meditation program, 44% said yes. So this research aims to find out if an online mindfulness-based program is acceptable for melanoma survivors.
The results of this research will be used by the student investigator, Ms Lahiru Russell,to complete her Doctor of Philosophy (PhD).
This research is being conducted by the School of Nursing and Midwifery at Deakin University, and the Peter MacCallum Cancer Centre at the Victorian Comprehensive Cancer Centre.
3. What does participation in this research involve?
In order to participate in this study, each participant will need to have access to a computer, a smartphone, or a similar tablet device, and internet. If you agree to take part in this project you will be allocated to either receive the mindfulness program (intervention group) or usual care (control group). We need to compare those two groups to see if the mindfulness program provides any benefits to cancer survivors. In orderto make sure the groups are the same, each participant is put into a group by chance (random). You will have two in three chances to be allocated to the mindfulness program.
If you decide to take part in this study, you will need to provide your consent to participate by accessing the following website: www.mindonline.org.au
All participants will complete a questionnaire before being randomly allocated to the intervention or control group. The same questionnaire will again be completed 6 weeks later. The questionnaire asks you questions about possible fears of the cancer coming back, how stressful and worrisome you perceive your life to be, and the type of thoughts you generally focus on.
We will also collect your email address, which will be your username to access the website. Your email will also be used to send you reminders and other information related to the study.
Should you be randomised to the mindfulness program, you will receive an email informing you of your allocation group with instructions on how to access the website. Your participation will involve using the program for 6 weeks. The program is designed to help you understand the potential benefits of using mindfulness in your day to day life. You will be invited to:
• Watch some short videos at the start of each week. The videos will be introducing a new topic related to mindfulness.
• Practice short meditations twice a day. We will help you create a meditation routine by emailing you a direct link to guided meditations at times you will have chosen.
• Apply mindfulness skills in your day-to-day life.
At the end of each week, you will receive an email with a link to a brief survey asking questions about your involvement with the program, and how helpful you have found the weekly topic. You will also be able to share any other feedback you may have about the program.
Should you be randomised to the control group you will continue to receive your usual care from the Peter Mac. Your participation will involve completing the two questionnaires, at the start of the study, and 6 weeks later. You will then have the option to use the mindfulness program.
We will compare the results between those involved in the mindfulness program and those who do not, in order to see if there are any differences between the two groups.
There are no additional costs associated with participating in this research project, nor will you be paid.
4. Other relevant information about the research project
This study will show if the mindfulness program is feasible and acceptable to people with melanoma. Feedback from participants will help improve the program, which will later be tested in a larger study.
For this study, approximately 75 participants will be recruited from the melanoma outpatient clinic at Peter Mac.
5. Do I have to take part in this research project?
Participation in any research project is voluntary. If you do not wish to take part you don’t have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your relationship with those treating you or involved in your follow-up care, or your relationship with Peter Mac.
6. What are the possible benefits of taking part?
We cannot guarantee or promise that you will receive any benefits from this research; however, possible benefits for the community may include additional support for people who have completed treatment for melanoma.
7. What are the possible risks?
We do not foresee any potential risks associated with your participation in this project. However, in the event that you become upset or distressed as a result of your participation, the researcher can arrange for counselling or other appropriate support provided by staff who are not members of the research team. In addition, you may want to contact an external support service such as Lifeline services on 13 11 14, or www.mindhealthconnect.org.au.
8. What if I withdraw from this research project?
If you decide to withdraw, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to inform you if there are any health risks or special requirements linked to withdrawing.
If you decide to withdraw from the project, the researchers would like to keep the personal and health information about you that have collected. This is to help them make sure that the results of the research can be measured properly. If you do not want them to do this, you must tell them before you join the research project.
9. What happens when the research project ends?
If you wish to obtain a final copy of the research report describing the results of this study, please contact the principal investigator (Dr Donna Milne on 03 8559 7838, or email email@example.com)and she will arrange for a copy to be sent to you after completion of the study in September 2017.
Part 2: How is the research project being conducted?
10. What will happen to information about me?
Any information obtained in connection with this research project that can identify you (e.g. UR number, IP and email address) will remain confidential and will only be used for the purpose of this research project. It will only be disclosed with your permission, except as required by law.
Information about you may be obtained from your health records held at Peter Mac for the purpose of this research. By consenting to participate in this study you agree to the research team accessing health records if they are relevant to your participation in this project.
All the information you provided will be coded so you cannot be identified by name, and only the research team will have access to the list that can link your name to your data. All information will be stored in password protected electronic files or in a locked filing cabinet in the office of the research staff, and will be disposed of as confidential waste after seven years.
In any publication, information will be provided in such a way that you cannot be identified. You will not, for example, be mentioned by name in any future publication of the results.
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you have the right to access the information collected and stored by the researchers about you. You also have the right to request that any information, with which you disagree, be corrected. Please contact one of the researchers named in the last section below if you would like to access your information.
11. Who is organising and funding the research?
This research project is being managed by Ms Lahiru Russell at Deakin University, and is being funded by her postgraduate research award.
12. Who has reviewed the research project?
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the HREC of the Peter MacCallum Cancer Centre and Deakin University.
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.
13. Further information and who to contact
The person you may need to contact will depend on the nature of your query.
If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact:
• The principal investigator: Dr Donna Milne on 03 8559 7838, or email firstname.lastname@example.org
• The research student: Ms Lahiru Russell, email: email@example.com
• The student’s primary supervisor: Prof Patricia Livingston on 03 9244 6609, or email firstname.lastname@example.org
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:
• Consumer Liaison, Telephone: 03 8559 7517 - email@example.com
• Ethics Coordinator, Telephone: 03 8559 7540 - firstname.lastname@example.org
• Deakin University HREC Office Manager, Telephone: 03 9251 7129 - email@example.com
Declaration by Participant
I have read the Participant Information Sheet.
I understand the purposes, procedures and risks of the research described in the project.
I have had an opportunity to ask questions and I am satisfied with the answers I have received.
I freely agree to participate in this research project as described and understand that I am free to withdraw at any time during the study without affecting my future health care.
If you would like to participate in this study, please click on the button "Confirm and Start Survey" below to provide your consent to participate.
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