What is the PROMISE Trial?
During normal clinical appointments there may not be enough time for patients and their doctors to discuss how things are going and how they are really feeling. We want to test a new way of monitoring people during and after their cancer treatment.
We are inviting adults who are starting treatment for cancer to take part in the PROMISE Trial because we want to test a new way to monitor patients during and after their cancer treatment.
This will involve people filling out a quick electronic ‘checklist’ about their current symptoms at home before attending their hospital appointments. By having this information beforehand, the doctors will have a better understanding of an individual’s needs and what is most important for them in their ongoing treatment and care. The aim is to improve how people feel and reduce the chance that they will have bad symptoms or side-effects from their treatment.
What will happen to the information collected about me?
By signing the consent form, you consent to relevant research staff collecting and using your personal information for the research project. Any information that can identify you will remain confidential. All of your data, including MBS and PBS information, will be coded with a unique Participant ID number and stored separately from personal information, such as your name and address. It will be stored on a secure server at QIMR Berghofer Medical Research Institute and will only be accessible to approved study personnel. No personal information will be used outside this research study or in any reports from the study.
All the information we collect will be kept for at least 15 years after the end of the study. After this your identifying information will be permanently deleted from the computer system and any hard copies will be destroyed. This will ‘de-identify’ the data and make it impossible for anyone to link the information back to you. Data will be destroyed securely by the IT Department at QIMR Berghofer according to their standard protocols. In addition to this research project, we may also use your information for future projects related to cancer. Any such projects will have to be approved by the relevant scientific and ethics committees. Your information will not be disclosed to anyone else without your permission, except as required by law.
Your health records and any information obtained during the research project are subject to inspection (for the purpose of verifying the data) by the relevant authorities. This includes authorised representatives of the Sponsor, Professor Penelope Webb, Your Institution, Princess Alexandra Hospital, or as required by law. By signing the Consent Form, you authorise release of, or access to, this confidential information for the relevant study personnel and regulatory authorities as noted above.
Information about your participation in this research project will be recorded in your health records.
The results of this research project may be published and/or presented in a variety of forums but information will only be provided in such a way that you cannot be identified, except with your permission. For example, we will only report results for groups of people and not for individuals
In accordance with relevant Australian and Queensland privacy and other relevant laws, you have the right to request access to your information collected by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the study team member named at the end of this document if you would like to access your information.
What if I have a question about the study?
If you want any further information concerning this project you can contact one of the following:
- The Principal Investigator – Professor Penelope Webb (07) 3362 0281 or penny.webb@qimrberghofer.edu.au
- The Project Manager – Ms Karen Martin (07) 3845 3550 or karen.martin@qimrberghofer.edu.au