Study to Clarify Mammogram Screening Recommendations for Women

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"What is the best mammogram screening schedule for women? Clinical experts disagree. Help us find out!"
Age:
40-74
Gender:
Female
Keywords:
Mammogram, Breast Cancer, Women, Personalized Medicine, Screening, Cancer
Type:
Observational
Target:
100000 Participants
Investigators:
Description
A groundbreaking breast cancer screening study is underway in California and you may be eligible to be a part of it. It’s called the Wisdom Study. The aim is to determine if we can make screening better by personalizing each woman’s mammogram schedule, compared to the current one-size-fits-all, annual approach.

In the United States, most women start screening for breast cancer at age 40. This has been the standard for the past thirty years and is the guideline recommended by some professional organizations. But within the medical community, there is disagreement on whether this is the best approach. This has led to competing and conflicting guidelines. Women receive different screening recommendations depending on what clinician or specialist they visit. This has left many women confused about what age to start screening, how frequently to screen, and until what age.

The WISDOM Study (Women Informed to Screen Depending on Measures of risk) is being spearheaded by University of California physicians and scientists as part of the statewide Athena Breast Health Network. WISDOM is designed to test an approach that uses our understanding of personal breast cancer risk to try to optimize screening. This approach personalizes screening recommendations depending on a woman’s personal risk assessment: women at high risk are screened more frequently and beginning at a younger age, while women at low risk start later and are screened less frequently. The 5-year, 100,000 woman study will determine whether this approach works better than annual screening.
This study requires
This study does NOT involve any lab or clinic visits.
Participation is done completely online. However, a study coordinator is always available to answer questions or to help participants navigate the enrollment process.

Please register here: www.wisdomstudy.org

Participants will need to read and sign a consent form as well as a HIPAA form. The HIPAA form allows the study team to request the release of a participant's mammography record. The study team will need information on where a participant's last mammogram was performed (unless none to date) and if they are insured, providing us with their insurance information. NO health insurance is required to participate but some insurers are covering the genetics test as part of their covered services for members.

Participants in the personalized arm will be asked to submit saliva samples for genetic testing of 9 genes associated with increased breast cancer risk.
Who can participate?
Women aged 40-74 living or receiving healthcare in California.
Women without history of breast cancer or DCIS.
Women without history of prophylactic mastectomy.
Benefits and risks of participating
Genetic Testing Risks:
The Wisdom Study tests a personalized, risk-based approach to breast cancer screening. There is a small chance we will find that you have inherited a variation in a gene (like the BRCA1 and BRCA2 genes) that is known to be related to breast cancer risk. Learning that you carry this type of variation (often called a “mutation”) in a gene can be uncomfortable, surprising, or cause some anxiety. The genes that will be tested may also affect your risk of ovarian and other cancers. Although this is a risk, there is also potential benefit to identifying these genes because it gives you the opportunity to take action to reduce cancer risks.

These mutations are rare- we estimate that only about 1% of WISDOM participants will be found to have one. If we discover that you carry one of these mutations, a Breast Health Specialist will contact you to discuss your result and what it means. Genetic test results may also have implications for blood relatives. If you have concerns, please discuss this with the study team.

In order to make progress in the science of understanding breast cancer risk, and for genetic tests to improve, we will share your inherited (genetic) risk data in a de-identified way (meaning none of this can be traced back to you by anyone, including the study team) to research databases. There will be no link between the records, therefore the study team will not be able to go back to link the data that was sent to the database with your identity. None of your genetic risk data is stored in these databases with your name, address, birth date, or Social Security number. If you have a genetic mutation that increases your risk of cancer, there are state and federal laws that protect your privacy. These include the Genetic Information Nondiscrimination Act, which makes it illegal for employers and health insurers to use certain kinds of information about your genes to discriminate against you.

Through this mechanism, the research community can learn from a larger collection of data and help inform us of the best way to interpret all genetic testing results. We will inform you if improvements are made to the interpretation of genetic data relevant to you.

Survey Risks:
Some women may feel uncomfortable answering questions about well-being, anxiety and breast cancer worry.

Mammogram Risks:
Mammograms are part of the standard of care and therefore pose no additional risk than what you would encounter if you were not in the study. As part of this study, you will receive recommendations for when to get your next mammogram. Both groups in the study will be receiving recommendations that align with national recommendations, and no one will get screened less frequently than the United States Preventative Services Task Force guidelines.

Loss of confidentiality: Loss of confidentiality is also a potential risk. All precautions will be taken to make sure your name and medical record number will not be associated with your study data, but a risk to your confidentiality will always be present. Your genetic test results and health information may be placed into a scientific database. Even though this will not be labeled with your name or any other identifying information there is a small risk it could be traced back to you. The risk of these things happening is small.

ARE THERE BENEFITS TO TAKING PART IN THE STUDY?

By participating in this study, you will help our efforts to answer two important questions. One is what the best schedule is for mammograms for all women. The other is how to identify the most important risk factors that determine a woman’s risk for breast cancer. You may also have access to genetic testing that is not part of routine health care. Advances in the prevention, diagnosis and treatment of breast cancer are due to participation of women like you in studies like this. By participating you can gain more understanding of your health history as it relates to breast cancer, and help the study team find a solution in the breast screening debate.
Compensation
None
Resources
Schedule
Study duration and period
About one-hour, annually.
Recruitment period
From Aug. 14, 2017 to Nov. 30, 2018
Contact
Samrrah A. Raouf

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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