Experts recommend that if you’re due for a routine screening, consider postponing your mammogram for at least 6 weeks after the last dose of the vaccine. But if you have an urgent reason to get a screening, for example symptoms, don’t delay. For more information, click here.
Experts say that swollen lymph nodes are an expected side effect and that it’s a good sign the vaccine and your immune system is working. In clinical trials, 11.6% of those who received a first dose of the Moderna vaccine experienced a swollen lymph node. That number increased to 16% after the second dose. For more information, click here.
Ultimately, the benefits of breast cancer screening and treatment far outweigh the risks of COVID-19 infection when public health measures are followed (wear a mask!). It's essential to enable loved ones to participate, to give cancer patients the social support they need to make informed decisions and have the best possible outcomes. For more information, click here.
About the WISDOM Study
The WISDOM Study is working to find a better way to detect and prevent breast cancer, in partnership with women of all communities. The study compares two safe and accepted approaches to breast screening and recommends risk reduction strategies so together we can improve breast health for ourselves, our sisters, our daughters, and women in the future.
By participating in the WISDOM Study, you join a community of 100,000 empowered and committed women who are helping to determine the best way to screen all women– a way that most effectively finds breast cancers and reduces harm.
You will have access to the latest information on breast health and risk reduction provided by some of the top breast health experts in the country. You may also have access to advanced genetic testing that is currently not routinely available.
Breast cancer experts don’t all agree on how often a woman should get a mammogram and at what age they should begin screening. The WISDOM Study is designed to provide those answers. It will determine which of two methods is more effective at finding breast cancer and safer for women: routine annual screenings starting at age 40 or screenings that are based on a woman’s personal risk factors for breast cancer
The Athena Breast Health Network (“Athena”) and its collaborators are conducting the WISDOM Study. We are a group of breast cancer experts, health care providers, researchers, and patient advocates at five University of California Medical Centers (UC Davis, UC Irvine, UC Los Angeles, UC San Diego, UC San Francisco), the Sanford Health System in North and South Dakota, Iowa, and Minnesota, the University of Alabama at Birmingham, the Louisiana State University, the University of Chicago, and other top medical centers around the country. For more information on Athena, visit our website at www.athenacarenetwork.org. Please also visit the ‘Team’ page on our website to learn who is leading the study at each site.
The WISDOM Study has been funded by the Patient-Centered Outcomes Research Institute (PCORI), the National Cancer Institute (NCI), the Breast Cancer Research Foundation (BCRF), the Robert Wood Johnson Foundation, the Safeway Foundation, the V Foundation, the Mt. Zion Health Fund, and private donations from people like you.
You can join the WISDOM Study if this describes you:
-You identify as female
-You are between the ages of 40-74
-You have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS)
-You have not had both breasts surgically removed (prophylactic double mastectomy)
-You live in the US
The WISDOM Study services are provided at no cost to you. These services include breast cancer risk assessment, genetic testing (for those in the Personalized Arm), and Breast Health Specialist consultations (when applicable).
The WISDOM Study does not order or cover the costs of your routine screening services. These may include breast imaging (mammograms, MRI scans and ultrasounds), breast procedures, or any other standard of care tests.
The WISDOM Study strongly recommends that all participants confirm with their insurance carrier all breast health-related costs that they may be responsible for paying, prior to scheduling an appointment.
Your insurance coverage and co-pays for breast imaging will not change as a result of study participation.
You will not be paid for taking part in this study.
Informed consent is a voluntary agreement to participate in a research study. The purpose of informed consent is to provide you with information about the study’s purpose, procedures, risks and benefits. This information helps you decide if you want to participate in a study. Please contact us if you have any questions while reviewing the WISDOM Study Consent.
Once you review the document and your questions are answered, you can choose to participate by signing the WISDOM Study Consent electronically. This indicates to us that you agree to participate. Please know that research is always voluntary and you may withdraw from the study at any time.
To view or download/print the WISDOM Study Consent, click here.
- During your WISDOM enrollment, there are three forms to review and sign as part of the informed consent process: WISDOM Study Consent, HIPAA, and Authorization and Release of Health Information Form). The WISDOM Consent form explains the study procedures, risks and benefits to participating, and your rights as a research participant.
- The HIPAA form protects patients from inappropriate disclosure of their protected health information. HIPAA stands for the Health Insurance Portability and Accountability Act and is also known as the Privacy Rule. This form is generally required for any medical or research procedure.
- The ‘Authorization and Release of Health Information’ form is last. This is requested so our research team can access your breast density data from your mammogram report. Your breast density information goes into our risk assessment to determine your risk for developing breast cancer.
Your signature on all forms is required in order for you to participate in the WISDOM Study. You will sign these forms using DocuSign, which is integrated with the enrollment steps. If you have any questions while reviewing the forms, please contact us at info@WISDOMstudy.org or 855-729-2844.
If you are in the Annual Group:
- You will answer two questionnaires including questions about your health history.
- You will get your next mammogram one year from the date of your most recent mammogram. If you have never had a mammogram, you will be recommended to get your first mammogram.
- If the WISDOM Study team believes you are at higher than average risk for breast cancer, you will receive a copy of your detailed risk report. You will be offered the opportunity to discuss your risk with a Breast Health Specialist over the phone. A Breast Health Specialist is an individual who has specialized training in breast cancer risk assessment and genetics. Your Specialist may recommend follow-up activities, such as more frequent screening, or suggest ideas about how you may lower your risk for breast cancer.
- You will complete follow-up questionnaires every year for five years to see if there have been any changes to your health including your breast health or your family’s cancer history.
If you are in the Personalized Group:
- You will complete two questionnaires and provide a saliva sample (through a testing kit sent to you by US Mail). This test looks for inherited (genetic) risk factors for breast cancer. This kit tests for 9 gene mutations (including BRCA1 and BRCA2) and a collection of single nucleotide polymorphisms (SNPS), which are gene sequences associated with a risk of breast cancer. (Please see the FAQs on genetic testing for more details.)
- Next, you will receive a screening recommendation from the WISDOM team based on your answers to the health questionnaire, your breast density from your mammogram, and your genetic testing results. This screening recommendation indicates when you should return for your next mammogram. Your schedule for getting mammograms is based on whether you are at higher than average, average, or lower than average risk of developing breast cancer. You could be asked to return in 6 months, 1 year, 2 years, or you may be recommended to wait until a certain age to start screening (if you are not 50 already).
- If you are determined to be at elevated risk, you will receive a call from a Breast Health Specialist. S(he) may make recommendations on how you can reduce your risk for breast cancer.
- You will complete follow-up questionnaires every year for five years to see if there have been any changes to your health including your breast health or your family’s cancer history.
How It Works
Once you register for the WISDOM Study you will learn about the two study groups (Annual and Personalized). You will then decide if you agree to be randomly assigned to a study group or if you have a strong preference to pick your study group. You will complete questionnaires online about your health history. If you have had a mammogram in the past, our researchers will collect and review your mammogram reports for your breast density data. Based on this information, and your study group, our study doctors will determine your screening recommendation. You will also receive information about how to prevent breast cancer and stay healthy.
An important aspect of the WISDOM Study is an ongoing review of your breast health history and current exams by our clinical team in order to detect any changes to your breast tissue. As part of the WISDOM Study, you will have a personal account for a digital tool called Mammosphere. Mammosphere enables you to electronically request your breast health records from your doctor and share those records with the study team. Simple and secure.
Annual (or every year) screening is the practice of having a mammogram every year starting at age 40. This is the current guideline that many U.S.healthcare providers and patients follow. It is recommended by various medical professional groups such as the American Congress of Obstetricians and Gynecologists and the American College of Radiology.
Personalized screening is the practice of having a mammogram on a schedule that is based on a woman’s personal risk factors for breast cancer. This is a new approach to screening that we are evaluating in the WISDOM Study. The personalized screening approach expands on the guidelines recommended by the United States Preventive Services Task Force. These guidelines recommend that women get a mammogram every other year starting at the age of 50, and that women under 50 discuss when to start screening with their healthcare provider.
In the WISDOM Study if you are assigned to personalized screening, you could be asked to return in 6 months, 1 year, 2 years, or you may be recommended to wait until a certain age to start screening (if you are not 50 already).
Scientists have studied and agree that having a computer randomly assign participants to a group (like the flip of a coin) is the very best way to compare two options without bias.
If your healthcare provider is within the University of California, University of Chicago, Louisiana State University, the University of Alabama at Birmingham or Sanford Health systems, they may be notified of your study participation by a direct email, notation in your electronic health record, or direct outreach. If you receive care at a different facility, all the information will be available to you on your secure, password protected WISDOM participant portal. You are able to download the material and discuss it with your healthcare providers. For women in the Personalized study group who are found to have a positive genetic mutation, WISDOM will ask your permission to contact your physician to inform them and assure that appropriate follow-up is in place.
We understand how important your security and privacy is to you. When you share your information as part of the WISDOM Study, you are sharing with physicians and a research team that is part of the top breast health network in the country. Only trained staff from your assigned study site will have access to your identifiable information for the purposes of contacting you and ensuring we keep in touch. For the purposes of data storage and analysis, we will remove your identifying information and assign you a study number. Please see the consent form for more details. We are committed to the security of your information.
Decades of research have provided us with a better understanding of breast cancer biology and the factors that contribute to breast cancer risk. The WISDOM Study will give us the opportunity to use what we now know to find the safest and most effective breast screening program for all women. We will be looking at the following factors to determine your breast cancer risk, regardless of which study group you are in (Annual or Personalized):
- Your age
- Your race/ethnicity
- Your family history of breast cancer
- Your history of benign (non-cancer) breast procedures
- Your breast density (how fibrous and glandular your breast tissue is, which can be seen on your mammogram)
If you are in the Personalized study group, these additional factors will be included in your breast cancer risk assessment:
- Your genes (inherited gene mutations that have been linked to breast cancer risk)
If you move during the study, please update your contact information on your secure WISDOM participant portal, and contact your study coordinator at firstname.lastname@example.org or 855-729-2844.
We will communicate with you by email, primarily. We will send you reminders to complete study steps, notify you when your results are ready, and send you updates from the team. We may also contact you by phone or text, so we ask that you provide your phone number. We will only use your contact information for WISDOM Study communications, and will not sell your information to any third parties.
If you discover a breast lump or other breast symptom, please contact your Primary Care Provider who will make an evaluation and recommend appropriate next steps. Please do not delay getting a mammogram to evaluate a symptom due to your involvement in the WISDOM Study.
As a participant, we ask that you complete a yearly questionnaire for five years to keep us updated. If your risk should change based on changes in your personal health or family history, we will update your screening plan.
Changes to your insurance do not affect your participation in the study.
Though not mandatory, you can update your insurance information by making changes within your secure WISDOM participant portal, or reporting the changes in your annual survey.
Color Genomics provides the genetic testing for the WISDOM Study. They will mail a saliva kit to your home to collect your saliva sample, along with a return box and shipping label to mail the sample back to the lab. Color Genomics will conduct their genetic analysis and return the results to the WISDOM Study team to provide to you. The Color test used in the WISDOM Study only tests for genes linked to breast cancer risk and does not test other genes in the standard commercial Color test.
The WISDOM Study is looking at nine genes associated with breast cancer risk. These nine genes are:
In addition, the WISDOM Study is looking at more than 120 single nucleotide polymorphisms (SNPs), which are small changes in certain genes that individually do not mean much, but together can increase or decrease a woman’s breast cancer risk. In most cases, the SNP score itself will not place a woman into a higher risk category.
Women in the Annual Group will not receive genetic testing through the WISDOM Study. However, they can purchase the genetic test directly from Color by visiting www.color.com.
Color's emphasis is on providing you with the highest quality results possible, and that means giving individual attention to every sample. The average turnaround time is currently 4-10 weeks from the day your sample is received at the laboratory, but the actual time will be subject to the data associated with each unique sample. Color will notify you via email each step of the way: when your kit has shipped, when you've successfully activated it, when your sample has arrived back at the lab, and when your results are ready.
As a part of the WISDOM Study, a number of genes will be tested to see if you have a genetic mutation that is associated with increased breast cancer risk. It is possible that, as new genes related to breast cancer risk are discovered, they may be added to the list. We will notify you if changes to your medical care are indicated. We will provide the results of your genetic testing to you as part of the WISDOM Study. A Breast Health Specialist will be available to talk with you about your results and what they mean to your health and to your family members’ health. In addition, Color will also look for small alterations in all your genes that might contribute to breast cancer risk. Scientists call these minor differences single nucleotide polymorphisms (SNPs). The SNP results will not be returned to you, but will be incorporated into your screening recommendations. Please note: only 1-3% of women test positive for a gene alteration.
No. The Genetics Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects individuals from genetic discrimination in health insurance and employment. The Act prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. It also bars employers from using individuals’ genetic information when making hiring, firing, job placement, or promotion decisions. For more information about GINA, please click here.
If you are seen at a participating health center in the University of California (Athena Breast Health Network), your genetic testing results and study screening recommendations may be entered into your electronic medical record.
If you have never been seen within the University of California or Sanford Health Network, your information will be available only to you on your secure WISDOM participant portal. You may share these results and recommendations with your primary care physician if you wish.
Additional information about the SNPs can be found in the publications cited below.
Mavaddat N. et al. Prediction of breast cancer risk based on profiling with common genetic variants. J Natl Cancer Inst. 2015 Apr 8;107(5).
Wen W., Shu X. et al. Prediction of breast cancer risk based on common genetic variants in women of East Asian ancestry. Breast Cancer Research 2016(18), https://doi.org/10.1186/s13058-016-0786-1.
Shieh Y, Fejerman L et al., A polygenic risk score for breast cancer in U.S. Latinas and Latin-American women. J Natl Cancer Inst. 2019 Sep 25. pii: djz174.
Mavadd t N., Michalidou K. et al. Polygenic Risk Scores for Prediction of Breast Cancer and Breast Cancer Subtypes. American Journal of Human Genetics 2019; 104(1): 21-34 https://doi.org/10.1016/j.ajhg.2018.11.002.
Color shares participant’s genetic testing data with the WISDOM Study for use in the study.
WISDOM Study participants will be able to access their genetic results report in their secure WISDOM Study portal.
Upon request, the WISDOM Study can share the genetic testing results and the raw data with the participant’s healthcare provider.
As a part of the study, a number of genes will be tested to see if you have a genetic mutation that is associated with increased breast cancer risk. It is possible that as new genes related to cancer risk are discovered, they may be added to this list, and we will notify you if changes to your medical care are indicated. We will provide the results of your genetic testing to you as part of the study.
In addition, Color Genomics will also look for small alterations in all your genes that might contribute to breast cancer risk. Scientists call these minor differences single nucleotide polymorphisms (SNPs). The SNP results will not be returned but will be incorporated into screening recommendations. Please note, only about 1-3% of women test positive for a gene alteration.
For participants who test positive for a mutation, a WISDOM Study Breast Health Specialist will be available to talk to the participant about their results.
Unfortunately, the WISDOM Study is not able to utilize the results from past genetic test. The genetic testing kit that Color provides to WISDOM Study participants includes analysis of a specific number of variants and SNPs that is unique to the WISDOM Study.
If you are interested in having your genetic testing results accounted for in your screening recommendation, please complete the Color saliva kit that will be sent to you.
Color takes your privacy very seriously, and only collects the information that is necessary to return high-quality and accurate results. Color complies with the applicable privacy and security rules established by HIPAA, which is the same standard followed by hospitals and other healthcare institutions. Our compliance with HIPAA means that all personally-identifiable health information is encrypted and stored safely. Color only shares information with the test user and the ordering provider, as well as additional healthcare providers designated by the test user.
Color also does not sell any information to third parties. WISDOM participants are initially opted out of third-party research. During enrollment, WISDOM participants can access their account settings to control how Color might share their data with outside parties, such as third-party researchers.
Color does not license others to conduct research on saliva samples that are analyzed for the WISDOM Study.
Color does however donate de-identified variants (gene mutations) that are found through their genetic analysis, to public variant databases, such as the National Center for Biotechnology Information’s (NCBI) Clin Var. Clin Var is a public archive where anonymous genetic information is accessible to researchers to better understand the connection between genetics and disease. WISDOM Study participants cannot opt out of this.
Initially, Color sees a participant’s general information (name, date of birth, address, race) in order to conduct an internal quality control check that helps to minimize the potential for sample swapping. Once the initial quality control check is complete, all WISDOM participant data is de-identified. De-identified means that all personally identifying information (e.g. name, birthdate) is removed.
Participant’s data remains de-identified during both Color’s genetic analysis and for Color’s internal, ongoing quality control and quality improvement checks. Color performs these processes on all data to ensure high performance in Color’s lab.
Any leftover saliva samples that are not needed for the analysis, will be returned to the WISDOM Study. WISDOM Study participant’s saliva samples are not stored at Color Genomics.
The WISDOM Study team will not order your mammogram. When you are due for your mammogram, please contact your Primary Care Provider to request a mammogram referral or follow the procedure that you have prior to joining the WISDOM Study.
An important aspect of the WISDOM Study is an ongoing review of your breast health history and breast density, which is found in your mammogram report. If you seek care at a University of California Medical Center, Sanford Health, or University of Chicago, the WISDOM Study team will obtain your breast health records for you. If you do not seek care at any of these institutions, we will request your records directly from your mammogram facility.
There are a few ways you can help the WISDOM Study get your mammogram report:
- If we are requesting your breast health records directly from your mammogram facility, it is important that we have the correct information. Each time you get a mammogram, please make sure to update the facility name and date of your last mammogram in the ‘Personal Information’ page in your WISDOM Study portal. This will help us make sure we are requesting the correct record.
- You can request your mammogram report to be sent to the WISDOM Study. If your healthcare provider does not charge a fee to request mammogram reports, please request that your mammogram report is delivered to:
UCSF Dept of Surgery, BCC, Box 0144
550 16th Street, Floor 6, San Francisco, CA 94143
Fax number: (415) 476-0272
- If you have access to your mammogram report, you can upload it directly in your WISDOM Study Portal. Your uploaded mammogram reports will be saved securely and available to you in your WISDOM Study Portal.
You can continue to get your mammograms from your current provider or select any provider you prefer. During the consent process, we ask that you sign a medical release form which allows us to request your mammogram and other follow-up records from your current mammogram provider.
No, participants are welcome to get either a 2D or 3D mammogram.
No, please get a screening mammogram. Diagnostic mammograms should only be obtained by women who either have a specific finding or have symptoms, and cannot be performed on women with no abnormalities or symptoms. This is why it’s important that women do not ignore symptoms. Screening mammograms are not 100% accurate and do not catch every cancer.