Clinical trial: NCT03426878
Section: Alternatives
Subsections: You Can Also Call The Genetics Department: (503) 331-6593. What Can This Test Not Do? This Test Cannot Tell If You Will Get Cancer Or Not.|This Test Cannot Tell You About All The Health Problems You Might Have Now Or In The Future.|What Are My Options?|What Are My Other Options?

No matter what your results are, many things can affect your chance of getting cancer, like smoking. Sometimes people get cancer no matter what they do.

Doctors are still learning about this test, so some of your results could be unclear or could change as doctors learn more. For some results, doctors may not know how to reduce your chance of getting cancer. In other cases, you may still get cancer even if you follow all of your doctor's advice. You may also need to see other doctors or get more testing, which could reveal other health problems not related to cancer.

You can choose to get this test or not. People have different views about the benefits and risks of the test. Some reasons why people may or may not want to get the test are listed below.  
If you do not get the test, you can talk to your doctor about what cancer screening you should get. Your doctor may recommend cancer screening based on you and your family's health history.

You do not have to join this study. You may be able to get the test from your doctor even if you decide not to join the study. If you choose not to join the CHARM study, you can talk with your doctor about this test. You can also call the Genetics Department to find out how to get the test: (503) 331-6593.  
You can also talk with your doctor first and then decide if you want to join the study.
Clinical trial: NCT03426878
Section: Confidentiality
Subsections: How Will My Information Be Shared And Protected?

We will protect and keep secure your test results and information. But there is a small risk that someone could find out who you are. If the study results are shared by accident, someone outside the study could see your information. There is a federal law, called the Genetic Information Nondiscrimination Act (GINA), that makes it illegal for health insurance and most jobs to discriminate against you based on your genetic test results. But this law does not cover other kinds of insurance like life insurance. This research is also covered by a Certificate of Confidentiality from the National Institutes of Health (NIH). This protects your personal information from lawsuits and court cases. We may not share information that identifies you with anyone outside of the study team unless you give your permission. But we must share things required by law, such as suspected child abuse or communicable diseases. We will also share your information in the ways described in this form, including putting it in your medical record and using it for other scientific research. You can still share information about yourself. You can freely discuss your involvement in this research.  
We will not share any of your personal information, like your name, address, or social security number, with people outside of the study team. But we will share your test results and other health information with other researchers. All of these researchers have agreed to protect your privacy and only use your information to learn about health and disease.  
We will also share your genetic testing results and study data with researchers across the U.S. We will not share any of your personal information. The NIH requires us to share your data so that other researchers can learn about health and disease from looking at many people's results. We will share all the results from the test. This includes results that you will not get because we do not know if they will affect your health. Only people doing approved research can request to access the data. This may include for-profit companies, but you will not profit from anything they learn.  
What rights do I have? You don't have to answer any questions you don't want to. You can leave the study at any time. But we cannot remove your test results after they are put in your medical record or shared with other researchers. A committee of researchers and patients has reviewed this study. Their job is to make sure that any risks to you are as small as possible and that your rights are protected.  
If you have questions, you can email or call us:  
  
You can also call the committee that reviewed this study:
- (503) 335-6725
Clinical trial: NCT03426878
Section: Duration of Study Involvement
Subsections: What Will Happen In The Study?

You will…
- **Spit saliva in a tube**. You can do this at home and send it in the mail, or you can do this with study staff at your doctor's office.  
- Learn if you have a **higher chance of getting cancer than most people**. - **Get your test results**. Most people will get their results on a phone call at a time that is good for them. Some people with normal results will get their results in a letter in the mail.  
- **Do surveys** and maybe **interviews** with study staff. - **Be paid** for your time. You will get $30 for giving your saliva sample and completing the first study survey, $25 for each additional survey (up to 2), and $20 for each interview (up to 2).
Clinical trial: NCT03426878
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are Some Reasons Why People May Not Want To Get This Test?|Will The Study Cost Me Anything?

- They may **not want to know** the information that it can tell them. Some people may worry while waiting for their test results or after receiving their results.  
- They may worry about getting **health insurance**. However, there is a law that says the test results cannot be used against you in health insurance.  
- It may be hard for them to talk about the results with **their children or other family**
members.  
- They may worry about getting **life insurance**. Some states have laws about this, but these laws can change. Because of this, some people choose to get life insurance before getting this test.

No. The test will not cost you anything. Your insurance will not be charged. But your test results may show that you need medical care in the future. This future care is often covered by insurance plans but each plan is different. The CHARM study will not pay for any future medical care you might need because of your test results.
Clinical trial: NCT03426878
Section: Procedures
Subsections: How Do I Do This Test?|We Will…

To do this test, you need to spit saliva into a tube. A team of doctors will test your saliva sample and talk with you about what your results mean.  
You can talk to your doctor to find out more.

- **Test your saliva sample** to learn more about your chance of getting cancer.  
- Share your results with your **doctor** and put them in your **medical record**.  
- **Look at your medical record** to learn about your health. This could include information about mental health and things other than cancer.  
- **Store your saliva sample and your health information**. - Use your saliva sample to **learn more about health and disease**. - Maybe **contact you later** to ask you other questions or to invite you to join other studies.  
We will also ask if you want to learn about other health problems that run in families. This is optional. This test can show a lot of different results about traits that run in your family. Most of these results will not affect your health, but some of them might show health problems other than cancer. Before you give us your saliva sample, you will be able to choose if you want to learn about health problems in you that may need medical attention. It is important to remember that this **does not include** all possible health problems. It also will not include results if we do not know if they will affect your health. You can choose to learn about all, some, or none of these results. You do not have to get these results to be in the CHARM study. A member of the medical team will talk with you on the phone about your test results. You will be able to ask all of your questions. We are comparing two different ways of explaining the results to people. We know both ways are good, but we want to see if one way helps patients better. To find out, we will use one way half of the time, and the other way the other half of the time.
Clinical trial: NCT03426878
Section: Purpose of Research
Subsections: [Test Information Page] [Title:] A Test That Can Tell You More About Your Chance Of Getting Cancer|What Are Some Reasons Why People May Want To Get This Test?|Why Might Some People Want To Get These Results?

Based on your answers about your family, we are offering you **genetic testing** through the CHARM study (Cancer Health Assessments Reaching Many). Genetic testing identifies changes in DNA that cause diseases that are passed down in families. The information that follows can help you decide if you want to get this test.

- They may want to learn about the chance of **their children and other family members**
getting cancer.  
- The results may make them **feel less worried about their health**. - The results may help them know what they can do to **find and treat cancer earlier**.

- To find out if they have a higher chance of a health problem that would not usually be found until they feel sick.  
- So they can take medical action to prevent or find and treat potential health problems.  
- So they can inform their family members.  
Why might some people not want to get these results?  
- They might not want to feel stress and anxiety from thinking about the results.  
- They might not want the additional doctors' visits that would be recommended for these health problems.  
- They only want to get their results about cancer that runs in families.  
Do you want to get results about the higher chance of health problems that may need medical attention?  
[Radio Button] Yes - I want to get these results.  
[Radio Button] No - I do not want to get these results.  
Continue [**Button;** requires selecting either yes or no to proceed. Error text "Please select your answer" appears under missing answer if attempt to proceed without answering]
[Go to Category Selection Final Page]
[Category Selection Final Page]
[Title:] Thank you for choosing if you want to learn about other health problems.
Clinical trial: NCT03426878
Section: Voluntary Participation
Subsections: Do You Want To Join The Charm Study?

If you answer no, we would like to look at the medical record of those invited to join. Our goal is to learn about the health and medical care of people who have cancer in their family but don't join the study.
Clinical trial: NCT03426878
Section: Withdrawal from Study
Subsections: What If I Decide Not To Join?

We will ask you if you agree to the study looking at your medical record. We want to learn about the health and medical care of people who have cancer in their family but don't join this study.  
We may ask you to do a short survey about why you don't want to join. We may also invite you to be interviewed or to join other studies.