Your consent is very important for us. Your information will only be collected when you agree to participate. Below is an electronic form that you can easily fill in and submit online. To download a hard copy for your own use or to post your consent form to us, please click here for a pdf version.
Part 1 – Consent form
Project Title: Measuring the impact of prehabilitation and rehabilitation for patients undergoing oesophagectomy
Coordinating Principal Investigator/ Principal Investigator: Dr Tim Bright, MBBS, MS, FRACS
Associate Investigator(s): Rohan Miegel, Jeff Bull, Caitlin Davis, Giang Trung Pham
Location: Physiotherapy department
Declaration by Participant
I have read the Participant Information Sheet or someone has read it to me in a language that I understand.
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 project without affecting my future health care.
I understand that I will be given a signed copy of this document to keep.
Part 2 – What does my participation involve?
1 Introduction
You are invited to take part in this research project, Measuring the impact of prehabilitation and rehabilitation for patients undergoing oesophagectomy. This is because you have participated in the prehabilitation program at the Physiotherapy Department of Flinders Medical Centre. The research project is aiming to demonstrate the impact of the current prehabilitation program on patient recovery after oesophagectomy and to help inform the implementation strategy of a prehabilitation program for broader cancer population groups.
This Participant Information Sheet/Consent Form tells you about the research project. It explains the tests and research 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 local doctor.
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 the research 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?
This study aims to measure the effect of early allied-health intervention, or prehabilitation, on the recovery of patients with oesophageal cancer (OC) after having surgery. Specifically, this study will assess the impact of the prehabilitation program being introduced at Flinders Medical Centre (FMC) on OC patients by measuring patient fitness at different timepoints through the program and after the surgery.
Currently, despite positive effect of prehabilitation has on patients undergoing major surgeries, the studies have shown mixed results about the effect of prehabilitation on OC patients undergoing oesophagectomy; hence, this project’s results will help inform the implementation of prehabilitation for OC patients and broader cancer population groups at FMC, especially for patients who need to undergo chemoradiotherapies before their surgery.
This research has been initiated by the study doctor, Dr Tim Bright.
3 What does participation in this research involve?
As you have already participated to the prehabilitation program at Flinders Medical Centre (FMC), you are invited to participate in this project. Your consent will need to be obtained before any of your information can be collected for this research project. By signing this consent form, you agree to participate in this project, and as a participant, your fitness data, health records and personal information will be collected, used, and protected as detailed in section 16.
As a participant, your routine care will not change, and apart from the scheduled prehabilitation sessions, there are no other commitments or appointments related to this project.
This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.
There are no costs associated with participating in this research project, nor will you be paid. You will not be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project visit.
4 What do I have to do?
As a participant, we would like you to be committed to the prehabilitation program you are participating in.
5 Other relevant information about the research project
We are aiming to recruit participants who already joined the prehabilitation program at Flinders Medical Centre (FMC). This research project is conducted at Flinders Medical Centre, and it is a feasibility study that will inform the implementation strategy of a prehabilitation program at FMC for larger groups of cancer patients. This project’s outcomes might also lead to further larger projects that help improve the pre-operative holistic care for cancer patients and patient recovery after cancer surgeries, especially for patients who undergo chemoradiotherapies before surgery.
6 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 do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
If you do decide to take part, you will be given this Participant Information and Consent Form to sign and you will be given a copy to keep.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine treatment, your relationship with those treating you or your relationship with Flinders Medical Centre.
7 What are the alternatives to participation?
As you have already participated in the prehabilitation program at FMC, you do not have to take part in this research project to keep being involved in the program.
8 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 may include having less risk of developing post-operative complications and reducing your length of hospital stay after your surgery. The results of this project will also help inform the implementation strategy of a prehabilitation program for broader cancer population groups undergoing chemoradiotherapies and cancer surgeries. Furthermore, this project can also lead to further larger projects contributing to the improvement of the pre-operative holistic care for cancer patients and patient recovery after cancer surgeries, especially for patients who undergo chemoradiotherapies before surgery.
9 What are the possible risks and disadvantages of taking part?
If you become upset or distressed as a result of your participation in the research, the study doctor will be able to arrange for counselling or other appropriate support. Any counselling or support will be provided by qualified staff who are not members of the research project team. This counselling will be provided free of charge.
11 What if new information arises during this research project?
Sometimes during the course of a research project, new information becomes available about the program that is being studied. If this happens, your study doctor will tell you about it and discuss with you whether you want to continue in the research project. If you decide to withdraw, your study doctor will make arrangements for your regular health care to continue. If you decide to continue in the research project you will be asked to sign an updated consent form.
Also, on receiving new information, your study doctor might consider it to be in your best interests to withdraw you from the research project. If this happens, he/ she will explain the reasons and arrange for your regular health care to continue.
13 What if I withdraw from this research project?
If you decide to withdraw from this research project, please notify a member of the research team before you withdraw. A member of the research team will inform you if there are any special requirements linked to withdrawing.
If you do withdraw your consent during the research project, the study doctor and relevant study staff will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected by the study investigators up to the time you withdraw will form part of the research project results. If you do not want them to do this, you must tell them before you join the research project. It is also unlikely that your withdrawal has any implications on your health.
14 Could this research project be stopped unexpectedly?
This research project may be stopped unexpectedly for a variety of reasons. One of the reasons might be that the results demonstrate there is an adverse impact of the prehabilitation program on your recovery.
15 What happens when the research project ends?
At the end of this research project, investigators will assess the impact of the current prehabilitation program at Flinders Medical Centre on oesophageal cancer patient outcomes after surgery. The results obtained will inform the implementation strategy of a prehabilitation program for larger groups of cancer patients and will be used for further research related. This project’s outcomes will likely be presented in academic conferences related to Surgery and Allied Health. Should you wish to be provided with a summary of the results, please provide your email address in the consent form
Part 3 – How is the research project being conducted?
16 What will happen to information about me?
By signing the consent form, you consent to the study doctor and relevant research staff collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Only study investigators will have access to your personal information, and your personal identifiable information will be permanently removed from the data used for analysis. The data will be kept and later archived for 15 years in Oesophago-Gastric Surgery Unit and Physiotherapy Department of FMC. As the study data is of electronic format, it will be permanently removed from all the devices containing it at the end of the storage period. Your information will only be used for the purpose of this research project and future research related to the prehabilitation program at FMC. Your information will only be disclosed with your permission, except as required by law.
Information about you may be obtained from your health records held at Flinders Medical Centre for the purpose of this research. By signing the consent form you agree to the research team accessing health records if they are relevant to your participation in this research project.
Your health records and any information obtained during the research project are subject to inspection for the purpose of verifying the procedures and the data. This review may be done by the relevant authorities and authorised representatives of the institution relevant to this Participant Information Sheet, Flinders Medical Centre, or as required by law. By signing the Consent Form, you authorise release of, or access to, this confidential information to the relevant research personnel and regulatory authorities as noted above.
It is anticipated that the results of this research project will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. Specifically, your identifiable information will be permanently removed from the data used and presented.
In accordance with relevant Australian and/or South Australian privacy and other relevant laws, you have the right to request access to the information collected and stored by the research team about you. You also have the right to request that any information with which you disagree be corrected. Please contact the research team member named at the end of this document if you would like to access your information.
Any information obtained for the purpose of this research project and for the future research described in Section 16 that can identify you will be treated as confidential and securely stored. It will be disclosed only with your permission, or as required by law.
17 Complaints and compensation
If you suffer any injuries or complications as a result of this research project, you should contact the study team as soon as possible and you will be assisted with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.
18 Who is organising and funding the research?
This research project is being conducted by Dr Tim Bright and is not funded.
By taking part in this research project, you agree data generated from analysis of your medical records may be provided to Flinders Medical Centre.
Flinders Medical Centre may directly or indirectly benefit financially from knowledge acquired through analysis of your samples.
You will not benefit financially from your involvement in this research project even if, for example, knowledge acquired from analysis of your medical records prove to be of commercial value to Flinders Medical Centre.
In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to Flinders Medical Centre, the study doctors or their institutions, there will be no financial benefit to you or your family from these discoveries.
No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages). Study investigators declared that they do not have any conflict of interest in relationship to this project.
19 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 Southern Adelaide Health Network.
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.
20 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 medical problems which may be related to your involvement in the project (for example, any side effects), you can contact the principal study doctor Dr Tim Bright on (08) 82046086 (mention prehabilitation study).
Clinical contact person
| Name | Dr Tim Bright |
| Position | Head of Oesophago-Gastric Surgical Unit |
| Telephone | (08) 82046086 |
| tim.bright@sa.gov.au |
For matters relating to research at the site at which you are participating, the details of the local site complaints person are:
Complaints contact person
| Name | Simon Windsor |
| Position | Manager Research Governance and Ethics |
| Telephone | (08)82044507 |
| Health.SALHNOfficeforresearch@sa.gov.au |
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:
| Reviewing HREC name | SALHN HREC |
| HREC Executive Officer | Dominic How |
| Telephone | (08) 82046285 |
| Health.SALHNOfficeforresearch@sa.gov.au |
Reviewing HREC approving this research and HREC Executive Officer details
Local HREC Office contact (Single Site -Research Governance Officer)
| Name | Karen Saxty |
| Position | Research Governance Officer |
| Telephone | (08) 82046139 |
| Health.SALHNOfficeforResearch@sa.gov.au |