Frequently Asked Questions
Table of Contents
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.
- Opportunity to learn about your personal risks for breast cancer.
- Receive updated yearly screening plans based on changes to your risk factors and latest scientific research findings.
- Potential access to advanced genetic testing that is currently not routinely available.
- Potential access to a online educational tool to learn more about your personal risks.
- Opportunity to consult with Breast Health Specialists.
- Stay informed of the latest science and research on breast health.
- Be a part of a growing, passionate community of breast health advocates!
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 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.
Study Participation
You can join the WISDOM Study if this describes you:
-You identify as female
-You are between the ages of 30-74
-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
Data shows that as women get older, diagnosed breast cancers are more likely to be slow growing and not immediately life threatening. When detected, these diagnoses can lead to overly aggressive, unnecessary treatment and unneeded stress. Because of this, the benefits of early diagnosis through screening don’t make as much of an impact in the cancers that typically develop over age 74.
Of course, every woman is different, both when it comes to risk for breast cancer and comfort levels of screening. Talk to your provider about any symptoms of breast cancer you might detect and if you think screening over the age of 74 is right for you.
If you turn 74 during your time on the study, your participation does not end.
Your participation in the WISDOM study lasts five years regardless of the age you were when you first enrolled. If you do not have a high risk for breast cancer, we may recommend stopping screening after 74, though you will still be a participant of WISDOM and will continue getting yearly recommendations
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.
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 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 what screening modalities to pursue(i.e. mammogram or MRI), when you should begin screening and at what time interval you should get screened. 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.
- 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.
On the initial consent form that participants completed, participants agreed to receive screening plans for 5 years, and allow WISDOM to stay in touch and review each participant’s breast health records for 10 years.
The WISDOM consent form is available for you to review both in your WISDOM Study portal and here.
We kindly ask that participants commit to five years of participation, which means completing yearly breast health surveys and receiving yearly mammography screening plans. After five years, participants will have the following options:
Option 1:
Continue with full participation in the study, which involves: completing yearly breast health surveys, receiving yearly screening plans, and having potential access to breast health educational tools and Breast Health Specialists.
Option 2:
Continue with limited participation in the study, which involves: completing short breast health surveys, and receiving updates on the latest science and research on breast health. Participants who select this option will not receive yearly, updated screening plans.
Updates to each participant’s breast health is vital to our study outcomes. We have narrowed down the survey to a handful of key questions so that participation is quick and easy.
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.
Yes, participation in the WISDOM Study is entirely voluntary. Please contact your Study Coordinator or email info@wisdomstudy.org if you’d like to withdraw.
How It Works
Once you register for the WISDOM Study you will learn about the two study groups (Annual and Personalized). You will choose your study group (Please note between the ages of 30-39 will automatically will be enrolled in personalized group; Annual group is only available to 40 and up age 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.
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 info@wisdomstudy.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 are diagnosed with breast cancer, you will still be a participant in the study. You can let us know by emailing info@thewisdomstudy.org or when completing your yearly questionnaires. We will then reach out with resources and to learn more about your diagnosis so we can improve our risk models in the future. Though you will be a participant, the WISDOM study will no longer provide a screening recommendation as you should defer to your doctor’s recommendation post diagnosis.
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.
Genetic Testing
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.
As of mid-October 2024, the WISDOM Study is using Color Health’s Hereditary Cancer Panel, which assesses 29 cancer related genes. Any test kit that is ordered starting in mid-October will assess the 29 genes. WISDOM is focused on twelve genes associated with breast cancer risk. These twelve genes are:
BRCA1
BRCA2
ATM
TP53
PTEN
CHEK2
CDH1
PALB2
STK11
BARD1 (new starting October 2024)
RAD51C (new starting October 2024)
RAD51D (new starting October 2024)
Additional cancer genes tested in the Color panel are: BRIP1, BMPR1A, SMAD4, GREM1, POLD1, POLE, MLH1, MSH2, MSH6, PMS2, EPCAM, APC, MUTYH, MITF, BAP1, CDKN2A, CDK4.
More details about these hereditary cancer genes can be found on Color’s website. If you test positive for a cancer related gene, the Color Health team will provide you with a genetics consultation. If you are positive for a breast cancer related gene, you will also receive a personalized consultation with a WISDOM Breast Health Specialist.
In addition to the 29 genes, the WISDOM Study is looking at 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. We use these SNPs to create a Polygenic Risk Score (PRS), which may impact your risk category (either increase or decrease your risk). For more information on PRS please read our blog article.
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.
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. Please note, GINA does not include protection from genetic discrimination in life insurance.
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 not sell any participant data without the participant’s specific consent. Color has not partnered with any pharmaceutical company to offer this option. If Color did offer this option in the future, Color would require participants to sign an Informed Consent, Privacy Policy and Terms of Service to assure that participants know exactly how Color would be using their data.
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.
For more information about Color’s Privacy Policy, please visit: www.color.com/privacy-policy, or contact privacy@color.com.
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.
Mammograms
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.
If you have insurance:
The Affordable Care Act, passed in 2010, requires most health insurers to cover mammography screening at least biannually with no cost sharing under the Health Resource Services Administration guidelines.
If you are concerned with whether your insurance covers your mammogram, please call your health insurance company to verify their specific policies.
If you don’t have insurance:
There are several resources if you do not currently have health insurance.
If you are currently uninsured, and your income is ≤250% of the federal poverty level, and are between 40-64, you may qualify for free or low cost screenings in your state. Visit this link at the CDC’s National Breast and Cervical Cancer Early Detection Program (NBCCEDP) to find a low or no cost screening program in your state.
Other resources that offer financial assistance or access to free mammograms include but are not limited to:
Planned Parenthood: Can often refer you to low-cost imaging centers.
Other local organizations in your area
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:
WISDOM Study
UCSF Dept of Surgery, BCC, Box 0144
550 16th Street, Floor 6, San Francisco, CA 94143
Fax number: (415) 353-8230
Email: info@wisdomstudy.org
- 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. To watch a tutorial on how to upload your mammogram click here. For a tutorial on how to download your mammogram results from MyChart click here.
A screening mammogram is a test that is done on a regular basis, when no signs or symptoms of changes to the breast are present.
The goal of a screening mammogram is to make sure there is neither abnormal tissue, nor cancer present in a woman with NO signs or symptoms of breast cancer. Screening mammograms are used as a regular method for detecting potential cancers.
Diagnostic mammograms are used only when screening mammograms identify a questionable finding, or when you identify symptoms of breast cancer like changes to your breast such as a self-detected lump. The goal of a diagnostic mammogram is to determine the underlying cause of the breast symptoms.
The WISDOM Study uses screening mammograms to calculate your breast cancer risk.
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.
No, participants are welcome to get either a 2D or 3D mammogram.
Breast density is a measure of how much fibrous and glandular tissue there is in your breast, as compared to fat tissue. Breast density is evaluated by a mammogram and information about your breast density can be found on your mammogram report. There are 4 categories of breast density:
- A: fatty or entirely fatty
- B: scattered areas of fibroglandular densities
- C: heterogeneously dense
- D: extremely dense
Fibrous and glandular tissue are harder to see through on a mammogram, so your breast tissue may be called ‘dense’ if you have a lot of these tissues (and not as much fat).
Having dense breast tissue is common. Some women have more dense breast tissue than others. For most women, breasts become less dense with age. But in some women, there’s little change.
If you are in the risk-based arm and have had a mammogram in the past, the WISDOM Study uses your breast density to calculate your breast cancer risk and screening recommendation. If we are unable to access your mammogram report, or if you’ve never had a mammogram, we may estimate your breast density.
For more on dense breast tissue, click here.
Environmental Exposures Research
For a long time, we have understood that exposures to some toxic pollutants at home and at work are associated with breast cancer risk. We also know that the burden of many environmental pollutants is highest among persons of lower socioeconomic status and persons of color.
However, when we started WISDOM in 2016, the development of robust environmental monitoring data was in its infancy, therefore risk models could not incorporate exposure information at the population level.
Now that the data and science have advanced, we want to learn more about how exposures influence breast cancer risk.
As of October 2023, WISDOM is launching new efforts to study the relationship between environmental exposures and women’s risk for breast cancer.
In order to learn how exposures influence breast cancer risk most accurately, we will need to gather data on your occupational and residential history.
We will do two things to obtain your occupational and residential history:
1. Send an optional questionnaire asking you about the places you have worked and lived
2. Link your information with a third-party data company called LexisNexis Inc to obtain further residential history information.
If you would prefer not to have your personal identifiers linked with LexisNexis, please contact the WISDOM study at info@wisdomstudy.org or call 855.729.2844.
One of the main goals of WISDOM is to capture the most important breast cancer risk factors so that we can improve our risk prediction models. Presently, we do not factor in a woman’s exposure to environmental toxins across her lifespan in our risk assessment. However, we recognize the importance of doing so, because some environmental exposures have been linked to increased risk for breast cancer. Our goal is to include data on environmental exposures in future research, and potentially integrate it into current risk models.
To estimate exposure to environmental toxins across a life span, researchers must capture detailed information on where a person has lived and worked during their life. Several epidemiological studies have used data available in third-party databases such as LexisNexis Inc to obtain detailed residential histories.
LexisNexis uses a myriad of data sources such as driver’s license and credit history records to compile addresses. Your first and last name, date of birth, and current address will be used to match addresses and dates of residence in the LexisNexis database. (In the future we will ask if you’d like to provide the last 4 digits of your social security number to improve accuracy of this linkage. This will be optional and will not impact your participation). There is high agreement (72-93%) between LexisNexis addresses and participant-reported addresses. Further, LexisNexis addresses accounts for approximately 71% of lifetime residential histories. This data will complement the optional residential history questionnaire we will also send to all participants. In future research we will use residential histories to estimate cumulative environmental exposures over time and examine the association with breast cancer risk.
If you would prefer not to have your personal identifiers linked with LexisNexis, please contact the WISDOM Study at info@wisdomstudy.org or call 855.729.2844.
There are minimal risks associated with third-party data linkages for you.
Information about you (first and last name, current address, date of birth, – and last 4 digits of your social security number if you choose to provide them) will be shared with LexisNexis via an encrypted file. LexisNexis will then search their databases and compile residential addresses and corresponding dates at each location.
LexisNexis is routinely involved in similar research nationwide and has robust protocols for data access and sharing. For example, they ensure that there is a record of consent to data linkages for every participant and that there is IRB approval for the study.
Your data will be deleted from their system when the data linkage is complete. Therefore, there is minimal risk that your data will be leaked or used for purposes outside the scope of this study.
Presently, we will not share the environmental exposure information we obtain from your occupational and residential histories back with you. This is because these estimates are at the neighborhood-level and do not necessarily reflect your individual burden. Also, there are no established protocols for returning information on neighborhood-level environmental exposures. However, all the environmental data we will use is publicly available and we can share these datasets with you so that you can look up exposures at your address and where you work. These datasets are captured and created by the United States Environmental Protection Agency (EPA) and quantify environmental exposures at the census tract level. In our process, we assign the address in which you live to a given census tract, and then utilize the EPA data to estimate the environmental exposure burden in that given location. The datasets we use examine several different types of environmental exposures including but not limited to: air pollution, superfund site proximity and water pollution. In the future, if we find that this data influences breast cancer risk, we may share this information back with you.
Our estimates of your environmental exposures based on your occupational and residential history will not influence your risk estimation at this time. The study team must first investigate whether the information we collect is predictive of breast cancer risk and whether adding this information to risk models improves the accuracy. If we find that adding this information improves accuracy, we will integrate this new model into a subsequent version of WISDOM and participants will be notified about this change.
If you are interested in learning more about how environmental exposures may have been linked to cancer risk in the past, please see the following resources from the California Breast Cancer Prevention Partners:
https://www.bcpp.org/resource/california-breast-cancer-primary-prevention-plan/
https://www.bcpp.org/resource/right-to-know-exposing-toxic-fragrance-chemicals-report/
WISDOM 1.0 and WISDOM 2.0 Comparison
We are implementing three major changes in WISDOM 2.0 (starting spring 2023):
All participants will be asked to choose a study group.
Women ages 30-39 are now eligible to join the “Personalized” arm of the study (starting fall 2023)
We are using updated tools to improve how we evaluate your breast cancer risk
If you enrolled in WISDOM before March 1, 2023, you are part of WISDOM 1.0.
If you enrolled on or after March 1, 2023, you are part of WISDOM 2.0
If you are unsure when you registered, please email info@wisdomstudy.org.
If you have been in WISDOM 1.0 for five or fewer years, then this does not change your participation. It is still important for you to keep in touch with us and to complete your yearly Breast Health Questionnaires. You will continue to receive updated screening plans.
In late 2024, we will begin inviting participants from WISDOM 1.0 who have completed five years in the study to enroll in W2.0. When you join WISDOM 2.0, you have the choice to remain in your original study group (Annual or Personalized), or you can switch study groups.
Yes! Your surveys allow us to keep track of any changes to your breast health or the health of your family members. This allows us to provide you with the most up-to-date screening plan. Additionally, the longer we can keep in touch, the more your data contributes to our goal of improving screening for all women.
WISDOM 2.0 uses updated risk models, including an updated polygenic risk assessment that can help predict your risk of developing more aggressive, fast-growing cancer.
Screening assignments will differ slightly from WISDOM 1.0. This includes starting screening for women in their 30’s at highest risk (less than 1% of all enrollees), and less frequent screening for those ages 50 and over in the lowest risk category (screening every 2-3 years).