This Information has been written to help you to decide if you would like to take part in The Australian Breakthrough Cancer (ABC) Study .

Please read this Participant Information carefully.

If you have any questions, please contact the study team on 1800 688 419 or email abcstudy@cancervic.org.au.

1. Your consent

If you agree to participate in the study, you will be asked to give your consent. This will indicate that you have read and understood this information and that you agree to take part in The ABC Study as described.

Please print or save the study information and Consent Form for your records.

2. Who runs The ABC Study?

The ABC Study is run by Cancer Council Victoria. The chief investigators are Professor Graham Giles, Director of the Council’s Cancer Epidemiology Centre, Dr Roger Milne, Deputy Director of the Centre and Dr Fiona Bruinsma, who is the Research Co-ordinator.

The ABC Study has been approved by the Human Research Ethics Committee of Cancer Council Victoria.

3. What is The ABC Study about?

The ABC Study seeks to understand the causes of cancer and other chronic diseases and aims to improve the prevention and treatment of these diseases in the future.

In particular, we will study the role of genes, lifestyle and exposures across the lifespan in the development of disease.

4. Who will be taking part in the project?

Those taking part in the ABC Study are Australian residents from 40 to 74 years of age and have never been diagnosed with cancer, other than non-melanoma skin cancer.

5. What does the project involve?

If you decide to take part in the ABC Study, you will be asked to do the following tasks.

(a) Questionnaires

You will be asked to complete four on-line questionnaires:

1. Residential History: asks about the places you have lived, for at least six months, over your lifetime.

2. Family History e: asks about your family and the history of cancer in your family.

3. Health and Lifestyle: asks questions about your body size history, smoking, some health conditions, use of medications, medical tests and your daily activities.

4. Diet: asks questions about your diet and alcohol consumption.

It is difficult to estimate the time that the questionnaires will take to complete, because it depends on the complexity of your family structure and medical history. You will not have to complete all the sections at one time. Once registered, you will be able to log in and out at any time. All completed details will be saved for you to continue at your convenience.

We will e-mail you a link to complete the questionnaires online. You are welcome to get someone to help you complete the questionnaires, if needed.

(b) Biological samples

As we will be studying the role of genes in the development of cancer, we need to study your genetic characteristics. To do this, we will be collecting some biological samples so that we can analyse your DNA (the chemicals that make up our genes).

• Saliva sample

  You will be asked to provide a saliva sample.

  A saliva kit will be sent to you in the post, which can then be returned to the study team in the reply-paid envelope we will provide for you.

• Blood sample

  A number of participants will also be asked to provide a blood sample.

  If we need to get a blood sample from you, we will ask you to visit your nearest pathology collection centre or the Research Clinic located at Cancer Council Victoria. You will not incur any costs for providing this sample.

• Tissue samples

  The ABC Study will be following the health of those taking part over a long period of time. Some might develop cancer, and part of their diagnosis or treatment could involve the removal of tumour tissue. As samples of these tissues are usually stored by the pathology laboratories, the ABC Study will request access tissue samples from the laboratories for use in the research.

Any saliva, blood or samples collected from you will be stored indefinitely at the Genetic Epidemiology Laboratory at The University of Melbourne. They will be stored securely and only authorised staff will have access to them. Your samples will be labelled with a unique code. Only designated staff will have the key to link that code to you.

Your samples could also be provided to other researchers in the future, for use in studies that have been approved by Cancer Council Victoria’s Human Research Ethics Committee.

As this type of research takes many years to conduct, those taking part agree to be followed over many years and alert us of any change to postal or email address, so that we may stay in touch.

6. What other information or materials will the ABC Study obtain?

Periodically, we will obtain information about you from other organisations.

This is done to update and verify our records without needing to contact you too often. The organisations that we might need to contact include: your doctor; your hospital; Cancer Registries; the Australian Institute of Health and Welfare (National Death Index, Australian Cancer Database), and Electoral Commissions.

Obtaining this information greatly facilitates us knowing about your health status.

7. How are my privacy and confidentiality protected?

Information that identifies you, such as your name, date of birth and address will be restricted to staff employed by the Cancer Council Victoria to maintain contact with you and the external laboratory that processes your samples.

Written information about you will be stored in an area with access restricted to a small number of staff, who are required to sign confidentiality agreements. All electronic records containing personal information will be stored on a password protected computer system. These will be protected by high level security measures. For further information, please refer to the Cancer Council Victoria Privacy Statement.

Your information or samples, that will not include your name, may be made available to other researchers, including interstate and overseas researchers, for studies that have been approved by Cancer Council Victoria’s Human Research Ethics Committee.

We will not include your name or other identifying information in any publication.

We have no plans to dispose of the information, saliva, blood or other samples we collect because the study will continue indefinitely.

In accordance with relevant Australian and/or Victorian privacy and other legislation, you have the right to access the information about you that has been collected and stored. You also have the right to request that any information, with which you disagree, be corrected.

Contact the project team on 1800 688 419 or email abcstudy@cancervic.org.au if you would like to access your information If you do so, you will receive a copy of all submitted questionnaires and responses, as well as any interpretable and applicable clinical findings available at the time of request.

8. How can I find out what the researchers learn from the project?

All participants will occasionally be sent newsletters which will highlight any interesting findings, as they become available, or future plans for the study.

Research can take a long time. We need to collect and test samples from many people before we can draw meaningful conclusions. The research using the information you provide could take some years to complete.

We will not be providing you with personal results, unless they have important implications for your health or the health of your family. If our research uncovers any such information, we will seek approval from Cancer Council Victoria’s Human Research Ethics Committee to contact you, or the members of your family affected by the information, and offer access to the information. You, or your family members, may decline to receive the information.

Participation in the study should not alter your use of routine health care or health screenings in any way.

9. Are there any benefits to me?

You might not receive any direct benefits by participating in the ABC Study, but the results of the research could benefit others in the future. This study is specifically looking at the influence of genetic and environmental factors on the risk of developing cancer and other chronic diseases. This will allow us to better prevent and treat these diseases in the future, including developing medical and screening programs that are more personalised.

10. Are there any risks to me?

Providing a saliva sample can be thought to be an unpleasant process. For those providing a blood sample, there could be a little discomfort as the needle goes through the skin and there might be some bruising. Feelings of light headedness or fainting might occur, in which case the person taking the blood will assist until the feeling goes away.

11. What if I no longer want to participate?

You can withdraw from the study at any time, without giving a reason, by contacting the study team on 1800 688 419 or email abcstudy@cancervic.org.au. If you choose to withdraw, we will continue to use your information and/or saliva, blood and tissue samples in the research unless you instruct us otherwise. Please let the study team know if you do not want us to continue using your information or samples.

12. What if I have more questions?

If you have any questions about the ABC Study, or would like any additional information before deciding to participate, please contact the study team on 1800 688 419 or email abcstudy@cancervic.org.au

13. What can l do if l have a complaint?

Cancer Council Victoria’s Human Research Ethics Committee has approved this study based on strict ethical standards and security of participant confidentiality and privacy. If you have any complaints or concerns about the manner in which this research is being conducted, please contact Ms Nicola Quin, Executive Officer of the Human Research Ethics Committee, tel: (03) 9514 6340, email Nicola.Quin@cancervic.org.au.

Thank you for your time. If you have any questions about The ABC Study, or want to talk about taking part in it, please call the study team on 1800 688 419 or email abcstudy@cancervic.org.au .