Breast Cancer Risk Assessment in Women Aged 40-49



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 49
Updated:8/22/2018
Start Date:July 1, 2017
End Date:July 1, 2021
Contact:Mara Schonberg, MD, MPH
Email:mschonbe@bidmc.harvard.edu
Phone:617-754-1414

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In a randomized controlled trial, the investigators will test the effect of a novel strategy
for breast cancer risk assessment and risk-based management of women in their 40s seen in
primary care. The investigators anticipate that this approach will lead to more optimal use
of mammography screening and breast cancer prevention interventions in women in their 40s and
as a result will improve care of these women.

There is currently no standardized practice for addressing breast cancer risk in primary
care. While there are guidelines encouraging PCPs to assess patients' breast cancer risk, few
PCPs assess patients' risk due to time constraints in primary care, lack of familiarity with
risk calculators, and knowledge on how to incorporate risk into the care of women. Around 20%
of PCPs have reported using a risk calculator but few routinely asses patients' risk. In
HealthCare Associates (HCA), Beth Israel Deaconess Medical Center's primary-care based
practice, the online medical record (OMR) has recently been edited to allow for PCPs to enter
patients' breast cancer risk. However, it is not known whether PCPs are using this tab. To
calculate patient's breast cancer risk, PCPs must go to web-based calculators, ask patients
their risk factors, enter the information and then add the estimated risk to OMR. Previous
studies suggest that leaving risk assessment to PCPs results in few women having their risk
assessed. Instead, PCPs tend to simply use family history when deciding whether or not
patients are at high risk. However, family history is only one risk factor for breast cancer.
Therefore, the investigators will send women ages 40-49 participating in this study a
questionnaire to complete before a visit to assess their risk factors for breast cancer.
Using this information, the investigators will calculate patients' breast cancer risk using
the available breast cancer risk assessment models and will present women with a personalized
breast cancer risk report immediately before a visit with their PCP. After the visit,
patients will be asked to complete a follow-up questionnaire about their experience and
through their medical records will be followed to learn whether or not they are screened with
mammography. The investigators will follow high-risk women to learn whether or not they
receive a screening breast MRI, BRCA gene testing, and/or the option to take breast cancer
prevention medications. The investigators aim to recruit 445 women 40-49 years seen at HCA
into a single arm trial to learn the effect of our personalized risk based approach to breast
cancer screening and prevention on women in their 40's intentions to be screened and
knowledge of the pros and cons of screening.

Specific Aims: To determine the effect of a personalized risk based approach for breast
cancer screening and prevention for women in their 40s seen in primary care on:

1. women's intentions to be screened with mammography (primary outcome),

2. knowledge of the pros and cons of mammography screening, and

3. decisional conflict around screening; and on

4. patient report of PCP discussion of their breast cancer risk and of the pros and cons of
mammography screening.

Inclusion Criteria:

- women

- aged 40-49 years

- read and speak English

- scheduled for a routine visit or physical examination with a non-resident PCP in the
next 4-12 weeks at HealthCare Associates (HCA, BIDMC's outpatient primary care
practice).

Exclusion Criteria:

- women scheduled for acute care

- women who had or will have a mammogram within 6 months of their PCP visit

- women with a history of breast cancer or a BRCA mutation

- women already receiving screening breast MRIs

- women who have been referred to genetic counseling

- women who have taken or are taking tamoxifen or aromatase inhibitors for breast cancer
prevention

- women with a history of an abnormal mammogram in the past two years

- women with a history of breast enlargement or reduction.
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Mara A Schonberg, MD, MPH
Phone: 617-754-1414
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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