Information for Participants


Why have I been invited?

A person is eligible to take part in the UGICR if they are:

  • 18 years or older
  • Newly diagnosed with a confirmed primary cancer of the pancreas, oesophagus, stomach, liver or biliary system
  • Have been diagnosed or received treatment for the cancer at a participating health service/district.

Potential participants are identified to the registry because they have been seen at a participating hospital to diagnose, manage or treat an upper gastrointestinal cancer. The registry may be notified about a potential participant directly from the treating hospital or through the Victorian Cancer Registry.

Participation

Participation in this registry is voluntary and has two parts:

Part 1: Collection of information from medical records

Trained registry staff will collect personal and health information relevant to your cancer from your medical records. This includes:

Name, date of birth, contact details, next-of-kin contact details, test results related to the cancer, cancer treatment details, names of treating hospitals and treating doctors.

Part 2: Questionnaires

You may be invited to participate in questionnaires about your symptoms and overall quality of care, over the course of your care.

What happens to my information?

Your information is stored securely at Monash University and will be used by the UGICR to generate reports for hospitals, publications, presentations, and future research projects that request registry data. The information will be reported in such a way that you cannot be identified.

Health professionals and researchers will use the information to ensure hospitals and other health care services are providing the most thorough and effective care for patients with upper gastrointestinal cancers.

If you do not want to take part in the registry


The UGICR is an opt-out registry, this means that you need to tell us if you do not want to participate. You can opt out of the registry at any time; however, data collection may start any time from two weeks after the date on the invitation letter mailed to you. If you choose to opt out after data collection has started, we can delete any collected  information.

There are two parts to participating in the registry and you can choose which parts you would like to opt out of:

  • I do not want to be contacted to complete questionnaires. (Partial Opt Out)
    This means you do not want to answer any questionnaires, but you are happy for trained research staff to collect important information from your medical records to help hospitals improve the care they give to people with upper gastrointestinal cancers.
  • I want to opt out of the whole registry
    This means you do not want to answer any questionnaires and you do not want information collected from your medical records. The registry will keep some key pieces of information in order to avoid sending another registry invitation letter to you in the future. If you do not want the registry to keep any personal information, you can request so at the time you opt out.

 

FREQUENTLY ASKED QUESTIONS (FAQ)


Why have I been included?

A participating hospital or a state-based cancer registry has identified you as having been diagnosed with an oesophageal, stomach, pancreatic, liver or biliary system cancer.

Do I have to take part?

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. This is an opt-out registry, this means that if you do not want to participate, you need to tell us. If you decide to take part, and later change your mind, you are free to withdraw from the registry at any stage. You can ask for your information to be deleted from the registry at any time, by calling 1800 432 231 (Toll Free) or send an email to ugicr@monash.edu

Your decision whether to take part will not affect your relationship with your treating hospital/s or specialist/s.

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, please contact: Ms Deborah Dell, Manager at Monash Health Human Research Ethics Committee, on 03 9594 4611.

What do I do if I have been invited, but do not want to take part?

If you do not want the registry to collect information from your medical record, please contact the registry, on 1800 432 231 (Toll Free) or ugicr@monash.edu

What will happen to information about me?

Your information will be used by the registry team to generate reports for hospitals, publications, presentations, and future research projects that require registry data. The information will be reported in such a way that you cannot be identified. Research projects that have been ethically approved may request to use data held by the registry.

The registry may link with other health or administrative data sets to better understand upper gastrointestinal cancer outcomes and care. For example, linking with hospital admissions data tells us if you have been readmitted to another hospital following cancer surgery. Datasets the registry may link with include but aren’t limited to biobanks, state-based cancer registries, Medicare, the Pharmaceutical Benefits Scheme, the National Death Index, and other relevant health data collections and research databases.

By taking part in this registry, you agree to the research team securely providing some identifiable data (such as your name, date of birth, address) to state/territory, commonwealth or other agencies for ethically approved data linkage activities. All linkages are performed in a highly secure way and identifiable data will be removed from the final dataset to ensure that individuals cannot be identified unless there is ethical approval for identifiable data to remain.

In accordance with relevant National and/or State 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.

Who has reviewed the research project?

The ethical aspects of this research project have been approved by the Human Research Ethics Committee of Monash Health. The ethics review panel includes community members and data privacy advocates, not just doctors and scientists. This project and related studies will be carried out in accordance with the National Statement on Ethical Conduct in Human Research (2007).

Who is organising and funding the research?

This research is being conducted by Monash University’s School of Public Health and Preventive Medicine with sponsorship from the Victorian Department of Health and Human Services, Pancare Foundation and some pharmaceutical companies. Additional sponsors
may support the project in the future. Current or future sponsors will NOT have access to your identifying information.

What do I do if I have been invited, and want to participate?

If you have received a Participant Invitation Letter and are happy for UGICR to collect your data and would like to participate, you are not required to do anything. You will automatically be recruited two weeks after the date your invitation letter was sent.

If you decide to take part, and later change your mind, you are free to withdraw from the registry at any stage. You can ask for your information to be deleted from the registry at any time. Please contact the registry on 1800 432 231 (Toll Free) or ugicr@monash.edu.

What is the purpose of this registry?

The UGICR collects information about diagnosis, treatment and outcomes of individuals with upper gastrointestinal cancer (oesophageal, stomach, pancreatic, liver or biliary system cancer). This information is used to measure the quality of care provided by hospitals and to help them understand how to improve care.

What are the possible benefits of taking part?

There will be no direct benefit to you from participating in this registry. The process of improving health care systems by providing hospitals with their quality of care data, takes a long time. This work is expected to benefit people diagnosed with these cancers in the future.

What are the possible risks of taking part?

This registry does not involve any changes to the medical care you receive. You will continue to receive the standard medical care; we simply record what happens to you.

There is a risk that you may become upset or distressed when contacted by registry staff, or when completing one of the questionnaires. Remember, you can choose not to complete the questionnaires or withdraw from the registry at any time. If you are distressed, the following resources may be helpful:

  • Beyond Blue on 1300 224 636
  • Pancare Specialist Support Team on 1300 881 698
  • Cancer Council support line on 13 11 20

What does participation in this registry involve?

1. Collection of information from medical records

Trained registry staff will collect information from your medical records. Only relevant personal and health information will be collected. This includes:

  • Your name, date of birth, address, phone number(s), email address, hospital record number(s), Medicare number
  • Contact details for your next-of-kin
  • Test results related to your cancer
  • Details of your cancer treatment
  • Names of the hospital/s and doctors treating you

To make sure all the essential information has been collected, your medical records will be reviewed several times over the course of your care. This information will be recorded in a secure database. You do not need to do anything.

2. Questionnaires

You may be invited to participate in questionnaires about your symptoms and overall quality of care, over the course of your care. Questionnaires may be completed online, by post or telephone. Questionnaires usually take about half an hour to complete. Information from these questionnaires may be sent back to your hospital. You do not need to go back to the hospital to complete this.

You may still participate in this registry even if you do not wish to participate in these questionnaires. Please contact the registry on 1800 432 231 (Toll Free) or ugicr@monash.edu if you do not wish to be contacted about these questionnaires.

Are there any additional costs or reimbursements involved in participating

There are no costs associated with participating in this research project, nor will you be paid.

How can I participate?

The UGICR is currently only collecting data on selected cancers of the upper gastrointestinal tract (oesophageal, stomach, pancreatic, liver
or biliary system cancer), at participating health services. If you have been diagnosed or treated for your cancer in one of the participating hospitals within the project timeframe, and you are eligible to be in the registry, you will be sent an invitation by post.

At this stage, we can only enrol people in the registry who have received an invitation. However, the registry is currently expanding to include more Australian hospitals.

How will my data be stored?

All research data will be stored indefinitely at Monash University. Monash University is aligned with ISO 27001 security practices. Data collected will be stored on University managed secure and resilient infrastructure located in Australia that complies with all applicable data protection and privacy obligations.