FAQ

The Healthy Oregon Project, or HOP, seeks to learn about the health of people in and around Oregon. Our overall goal is to understand the causes of cancer and other diseases in order to save lives. HOP combines surveys on health, wellness, and behavior with the voluntary collection of biological specimens (e.g., saliva), with data saved to a secure and privacy-protected repository of information that can be used to answer many different questions about health.

Our first research study is for the OHSU Knight Cancer Institute’s CEDAR (Cancer Early Detection Advanced Research) Center. This study is dedicated to understanding how a person’s genetics, their environment, and their behaviors may affect their risk of hereditary cancer and other health conditions. It is supported by a team of scientists, genetic counselors and community outreach specialists at Oregon Health & Science University.

This study supports a clinical trial funded by National Cancer Institute (NCI)’s Beau Biden Cancer Moonshot and will help determine if inherited cancer screenings should be part of general medical care for everyone.

The Heathy Oregon Project (HOP) aims to build a long-term research partnership with Oregonians in order to:

• Empower participants by providing personalized health information about their risk of cancer and other health conditions
• Make data/specimens (personal information removed) accessible to scientists who are working on early detection research and effective treatments for inherited diseases, such as hereditary cancer
• Create a robust repository which will serve as a resource for researchers to identify potential participants who would like to take part in future research opportunities

HOP is currently funded by the Knight Cancer Institute Center for Early Detection Advanced Research (CEDAR) and a Moonshot grant from the National Cancer Institute, National Institutes of Health. CEDAR is a research institute dedicated to identifying those at risk for cancer, detecting cancers early, and developing treatment that treat those early cancers. CEDAR is also supported by a collaborator network that is constantly growing.

Current collaborators include:

• University of Oregon Center for Science Communications Research
• Providence Cancer Institute
• Oregon State University
• Kaiser Permanente Center for Health Research
• Oregon Health Authority (OHA)
• Oregon Community Health Information Network (OCHIN)

Step 1: Download Healthy Oregon Project app from Google Play or Apple iOS app store.

Step 2: Click on “Join Study” when you open the app and sign an electronic consent in the app to participate.

Step 3: Create a secure account for the app.

Step 4: Explore and choose your options for participating in HOP within the “Activities” menu.

Step 5: If you would like to join the HOP inherited cancer and cardio risk study to receive your genetic cancer risk results after sending a saliva sample, click on the “Enroll: Genetic Screening” survey in the app to get started. Follow the prompts to consent and request a HOP Kit.

HOP is a repository. That means that we collect research data, samples and other information to share to answer scientific questions. One important thing to know is that we only share data with researchers that meet the OHSU ethics committee requirements; we do not sell data. We may share data with other organizations but this sharing is to answer scientific questions.

You must be at least 18 years old to participate in HOP. To participate in genetic screening, you must have an Oregon address to ship the screening kit to, this does not have to be your residence.

Regulations surrounding inclusion of children under age 18 limit our ability to allow their participation in HOP. If a parent or sibling is found to have a genetic risk for cancer and/or other health conditions it may be appropriate to consult a genetic counselor and/or have medical testing for children under age 18, but this is not part of HOP.

A research repository collects, stores and distributes human specimens (samples of blood, tissue, or body fluids) and/or data for use in future research projects. Storing and gathering lots of specimens and data together can help to conduct future research and avoid re-collecting specimens and data over and over again.

With this stored information and samples, researchers may understand better how the human body works, develop new tests to find diseases, find new ways to treat diseases, or develop new products such as drugs. When researchers collect and store many specimens and data together and use them for different kinds of research in the future, or share them with other scientists, this is called a research repository. HOP is a research repository.

Genetic screening is the process of identifying changes in DNA (and the genes within) that can confirm the presence of a genetic condition. Genetic screening usually involves sequencing DNA.

Participating in this research may provide benefits to the community as a whole. We would like to know if population level screening is appropriate and we are interested in identifying individuals at high-risk of developing cancer for early cancer detection projects. Our goal is to help understand the causes of cancer and other diseases in order to save lives.

Ancestry.com and 23andme mainly test for common genetic variation that is indicative of ancestry and ethnicity. This variation is not strongly associated with disease, even those diseases that are associated with ancestry or ethnicity. We are focused on screening for rare genetic changes that are strongly associated with cancer.

We are not currently measuring common genetic variation. However, if we do, we will develop ways of sharing data with our participants similar to Ancestry.com or 23andme.

If you choose to donate a DNA (saliva) sample, we will determine your sequence a small number of genes. We may, in the future sequence all of your DNA. Data and specimens will be stored in a tissue/data bank, called a repository.

Data and specimens collected from you will be stored indefinitely and may be used and disclosed in the future for research which may include genetic research.

This study will send your DNA to an OHSU medical laboratory to analyze your genes for genetic changes that are known to increase a person’s risk for developing cancer and other diseases. There is no cost to you. Most people will have a negative result for any of these genes and will have the results posted in the “results” tab of the HOP app within the account you created when you joined the study. If you are found to have a positive result that may indicate you have an elevated risk of developing cancer in the future, we will have a genetic counselor from the OHSU medical team, contact you by phone to guide you through your results. You will be given recommendations that the medical community have determined are likely to decrease your risk of developing a lethal cancer in the future.

Your results will be saved in our research repository for future research studies.

A positive diagnosis may cause you emotional stress. A positive diagnosis may also be the basis for recommended preventive measures that you may not be able to afford because of lack of insurance or limitations of your insurance. Many public programs are available in this case and the genetic counselors can help identify these public resources but there may be limitations to their availability.

Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. You are protected by a federal law, called the Genetic Information Nondiscrimination Act (GINA-2008), which generally prevents health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Your employer will not be given the result.

Although we have made efforts to protect your identity, there is a small risk of loss of confidentiality. If the results of these studies of your genetic makeup were to be accidentally released, it might be possible that the information we will gather about you as part of this study could become available to an insurer or an employer, or a relative, or someone else outside the study. Even though there are certain genetic discrimination and confidentiality protections in both Oregon law and federal law, there is still a small chance that you could be harmed if a release occurred.

The current HOP screening panel will let you know if you are at a higher risk for developing cancer or other diseases than the average population. If you have any of these genetic changes, there are preventive measures that can reduce your risk of developing certain diseases in the future.

Inherited cancers are those cancers that are more likely to have occurred as a result of an inherited genetic change. The most common inherited cancers are associated with Lynch syndrome and Hereditary Breast and Ovarian Cancer Syndrome.

HOP Kits are small boxes that contain everything you need to collect and return a saliva sample for genetic screening.

Each HOP kit comes with:

• instructions
• mouthwash
• a tube to collect your saliva
• a plastic bag to hold the tube
• pre-paid mailer for you to return your sample.

Complete the steps below to join for inherited genetic risk screening and to request a kit. Once you receive your kit, donating a DNA sample requires collecting a saliva sample using mouthwash and takes no longer than 5 minutes to complete.

Step 1: Download Healthy Oregon Project app from Google Play or Apple iOS app store.

Step 2: Click on “Join Study” when you open the app and sign an electronic consent to participate.

Step 3: Create a secure account for the app.

Step 4: In the HOP app navigate to Activities and click on Enroll: Genetic Screening. Follow the prompts to agree to participate and sign the consent form.

Step 5: Now that you have agreed to participate, navigate to the “Activities” tab and click on “Activity: Request a Kit” and enter your mailing information to have a kit sent to you. You will receive an email when the kit has shipped to you with the tracking information. It takes about 2 weeks to receive your kit.

Step 6: When your HOP Kit arrives, open the box and follow the directions within the kit to collect your sample.

Mail back using the U.S. Post Office’s pre-paid mailer.

You will receive your results within 6 months.

Your sample will be tested on the current gene panel that is listed in the HOP app at the time of consent. The diseases that are being screened for are described below.

Hereditary breast and ovarian cancer (HBOC) Families with HBOC have an increased risk for breast, ovarian, prostate, and pancreatic cancers. The genes associated with HBOC are BRCA1 and BRCA2.

Lynch syndrome Families with Lynch syndrome have an increased risk for colorectal, uterine, stomach and ovarian cancers. The genes associated with Lynch syndrome are MLH1, MSH2, MSH6, PMS2.

Familial adenomatous polyposis (FAP) and attenuated FAP Families with FAP or AFAP have an increased risk for colorectal, small bowel, pancreatic and thyroid cancers. The gene associated with FAP and AFAP is APC.

Other There are other inherited cancer syndromes that are screened for on our panel, but these are much less common.

Cardiology Risk We are currently screening one gene, LDLR, which is associated with Familial Hypercholesterolemia. Families with Familial Hypercholesterolemia have an increased risk for elevated cholesterol that is not manageable by normal diet. This condition typically requires medication to decrease health risks.

Many diseases are inherited. About 5-10% of cancers are inherited, meaning they can be passed down by family members. With the advent of genetic screening, it’s possible to look at a person’s DNA and determine whether there is an elevated risk for heritable cancers. With this information, you can take action earlier to prevent or identify cancer at its earliest stages when it is most curable.

We do not know what testing you had previously, so we cannot determine this. We are analyzing several genes associated with inherited cancer syndromes and other health conditions and some may not have been included in your previous testing.

No, you should keep your scheduled appointment. Most cancer genetic consultations are covered by your insurance company. This is a study designed for the general population. If you have a personal or family history suggestive of an inherited cancer syndrome, a consultation with a genetic counselor will allow individual assessment and pre-test genetic counseling, personalized genetic screening recommendation, results interpretation and future management recommendations based on your personal and/or family history. Additionally, genetic screening ordered by a genetic counselor will likely return results in about month and is intended for timely decision making.

Enrolling in this study is your choice. We are analyzing several genes associated with inherited cancer syndromes. Therefore, it is possible we could find a mutation associated with an increased risk for a type of cancer you have not had and are not screening for at this time. Additionally, if we find a mutation in you, your family members are at risk to have the same mutation.

No. Genetic screening is specifically protected by GINA (created in 2008), the Genetic Information Nondiscrimination Act.

Yes, but only if you have a positive test result. Putting this information into your record is required by the clinical testing lab to complete the test.

This is a personal decision and you should think about if this is right for you. You can enroll in and participate in HOP in other ways and wait to decide or choose to not donate a DNA sample for genetic screening.

No, this only tells you if you have inherited mutations in genes that could increase your risk of developing cancer in the future. Having a mutation does not mean you have or will develop a cancer.

As a participant in HOP you can choose to receive genetic screening at no cost to assess if you have a significantly increased genetic risk compared to most people for certain cancers and other health conditions. If a risk is identified you will also receive, at no cost, a genetic counseling consult with an Oregon Health & Science University genetic counselor and assistance with finding resources through the HOP participant navigator.

Costs for preventive measures (e.g., testing, medical procedures, medications) recommended by the genetic counselors and/or healthcare providers are not paid for by HOP. Recommendations are based on consensus medical guidelines and best clinical practice.

Although most insurance companies may cover the costs of the recommended preventive measures based on having a familial gene mutation, preventive care may not be covered in full. You may have out-of-pocket costs due to your deductible or copayment amount. You should first verify your insurance coverage with your before you undergo any medically recommended preventive measures.

If you do not have health insurance, the Participant Navigator can assist you with insurance enrollment or accessing financial assistance services available in most clinics and health systems.

The current gene panel for Genetic Screening is listed below. When these genes are altered, they may increase an individual’s risk for cancer and other health conditions. In the future, this panel will change as we add other genes that may identify other inherited diseases.

The panel that you agree to before you scan your sample in the HOP mobile app, will show you the most current screening panel that we will use to analyze your sample.

When you complete the process within the app to scan your saliva sample under “Activate: Donate a DNA sample”, you are given the option to have your DNA screened for additional genes added to the panel that may or may not be cancer or cardio related. This is your choice.

It is not always possible to rescreen all of our participants as we update the panel. We may only analyze the current panel you are presented with at the time of sample submission.

Medical guidelines may change over time as our understanding of genetics evolves and affects what we report back to you, as we only return a result that has medical guidelines that could impact your clinical care. The result you are given will be based on the current medical guidelines at the time a report is issued as they may have changed from the date you initially submitted your sample.

There are many reasons we may require a second sample. While all preliminary positive results will require a second sample, only 1 in 200 individuals are expected to have a positive result. It will not be uncommon for as many as 1 in 10 individuals to need a second sample collected. Usually this is because of a failed process in the laboratory.

The false negative rate is challenging to determine and depends on the type of mutation. It may be as high as 10% or more.

The rate of false positive results is very low. A second sample will be requested in the event of a preliminary positive result to ensure there was no error in the collection process.

Negative Results– Your results will be posted in the “results” tab within the Healthy Oregon Project mobile application (located in your secure account you create when you join the study).

Positive Results– the majority of participants will not have a positive result. If you have a positive result, you will be contacted by an OHSU genetic counselor by phone, and if they cannot reach you after several attempts they will email you to ask that you call them back. The Genetic Counselors will guide you through the results on the phone and review with you the recommended medical guidelines for your result, including options for preventive measures that could decrease your risk of developing cancer in the future. These are publicly established guidelines that are followed by the medical community.

The genetic counselor may assist you in helping to find resources for getting the recommended preventive measures if you do not have the financial ability to receive with your insurance or if you do not have insurance. Positive results for genetic abnormalities will be primarily communicated by a genetic counselor via the phone. They may try to contact you through paper mail or email to arrange a call. Positive test results will be uploaded into an OHSU medical record that will be created for you if you do not already have one, as having a medical record is a requirement for medical testing.

No. Under GINA, the Genetic Information Nondiscrimination Act, health insurers cannot use genetic information, including results of predictive genetic tests, to make eligibility and coverage decisions. Predictive genetic test results cannot be considered a pre-existing condition.

Example: A woman has a family history of breast and ovarian cancer. She talks with her doctor about a genetic test to determine if she has a gene mutation that increases her risk of breast and ovarian cancer. She has testing and learns she has a mutation in the BRCA1 gene, confirming her increased risk to develop those cancers. Her health insurer cannot request, require, or use her genetic test results to make decisions about her eligibility for coverage or the amount she pays for her health insurance.

No. GINA (Genetic Information Nondiscrimination Act) makes it against the law for health insurers to use information about diagnosed conditions in an individual’s family members. GINA defines family member as a first- (child, sibling, parent), second- (grandchild, uncle or aunt, niece or nephew, grandparent), third- (cousin, great grandparents, great grandchildren), or fourth-degree (second cousin, great-great grandparents, great-great grandchildren) relative.

For more information on the protections that GINA covers, you may get more information here: http://www.ginahelp.org/GINAhelp.pdf

Studies approved by an Institutional Review Board, a rigorous group of individuals responsible and required by federal law for ensuring that research meets legal standards for ethical research and other regulatory oversight entities responsible for ensuring human studies are being conducted in an ethical manner. HOP is a repository, so other researchers may request to receive data or specimens. HOP evaluates each case and ensures all regulatory requirements are met in order to share with any researcher.

If you have enrolled at a company event, no results will be shared with your employer as this study is not connected to your employer.

The data will be stored and used as a resource for general research. We plan to keep the data/specimens indefinitely. Samples will be stored at OHSU in a secure location and according to OHSU policy, only the study staff will have access to the samples prior to release for other research.

Insurance providers may have access to your medical records if you have a positive result (Positive results are uploaded to an OHSU medical record per the clinical testing laboratory requirements -one will be created for you if you do not have one, but negative results are not posted to your medical record) but under the federal genetic privacy law, GINA (Genetic Information Nondiscrimination Act), they may not discriminate (e.g. raising insurance rates) if they find a positive result because this is screening.

However, disability insurance and life insurance companies are not covered by GINA and they may require copies of your medical records to approve a new policy. We will not directly or intentionally share your positive result to insurance providers.

You will get your results back within 6 months. If the results are negative, your results will be uploaded into your secure HOP app account. You will receive an email to notify you that these results have been uploaded. If you have a positive result, you will be contacted by a genetic counselor to review your results.

If you have a positive test result, the genetic counselor will review with you the associated cancer risks and management recommendations. Cancer risks and management recommendations vary by gene and mutation. Most management recommendations include more frequent cancer screening beginning at an earlier age than is recommended for the general population, and/or risk reducing surgery options. For example, breast cancer screening including a breast MRI and a mammogram beginning at age 25-30 is recommended for women with a BRCA gene mutation.

The major disease types at this time are breast cancer, gynecologic cancers, and colon cancer. An increased risk for other cancers, including thyroid, kidney, and prostate cancers, is associated with mutations in some genes on the panel. If you have a positive test result, the genetic counselor will review with you the associated cancer risks and management recommendations.

We recommend that you ask your life insurance company about their particular policies.

No, we are unable to return raw data files at this time. You will receive a summary report of your genetic screening. If this changes in the future you may be offered this opportunity.

Your employer will not have access to your participant information/data.

No, it is not. This is a separate application that can be downloaded via the Apple Store of Google Play.

We recommend using your personal email address to maximize privacy. Your participation in this study is voluntary and unrelated to your employment. So if you were to leave your employer, this study will have a way to contact you.