Breast Cancer Risk Assessment in Women Aged 40-49
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Breast cancer risk report
Intervention type(s): Other
Intervention description(s): An individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Breast cancer risk; Primary Care; Women