Clinical trial NCT03180086: Breast Cancer Risk Assessment in Women Aged 40-49
Official title: Breast Cancer Risk Assessment in Women Aged 40-49
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer risk
Primary Care
Women
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 338
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Screening intentions
timeFrame: 1 week
Secondary outcomes:
measure: Screening intentions within risk groups
timeFrame: 1 week
measure: Knowledge of the pros and cons of mammography screening
timeFrame: 1 week
measure: Decisional conflict scale
timeFrame: 1 week
measure: Difference in PCP discussion of breast cancer risk
timeFrame: 1 week
measure: Difference in PCP discussion of pros/cons of mammography screening
timeFrame: 1 week
measure: PCP discussion of breast cancer prevention medications
timeFrame: 1 week
measure: PCP documentation of discussions of breast cancer medications
timeFrame: 1 week
measure: Prescription of breast cancer prevention medications
timeFrame: 6 months
measure: Time until breast screening MRI
timeFrame: 6 months
measure: Referral to genetic counseling
timeFrame: 6 months
measure: Attended genetic counseling
timeFrame: 6 months
measure: Time until next mammogram after intervention
timeFrame: 21 months
measure: Date of mammogram(s) after intervention
timeFrame: 21 months
measure: Type of mammogram(s) after intervention
timeFrame: 21 months
measure: No mammogram after intervention
timeFrame: 21 months
measure: Risk report acceptability
timeFrame: 1 week
measure: PCP facilitators and barriers
timeFrame: up to 24 months
measure: PCP risk of malpractice/litigation
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mara Schonberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schonberg MA, Davis RB, Karamourtopoulos MC, Pinheiro A, Sternberg SB, Jacobson AR, Aliberti GM, Mehta TS, Cluett JL, Cohen ML, Atlas T, Tung NM. A Pre-Test-Post-Test Trial of a Breast Cancer Risk Report for Women in Their 40s. Am J Prev Med. 2020 Sep;59(3):343-354. doi: 10.1016/j.amepre.2020.04.014.