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Breast Cancer Risk Assessment in Women Aged 40-49

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180086
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Mara Schonberg, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Breast cancer risk report Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Breast Cancer Risk Assessment in Women Aged 40-49
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 25, 2019
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast cancer risk report
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.
Other: Breast cancer risk report
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.




Primary Outcome Measures :
  1. Screening intentions [ Time Frame: 1 week ]
    Change in women's intentions to be screened with mammography after the intervention by 5-year breast cancer risk using a multivariable linear regression to examine the association between 5-year breast cancer risk and intentions to be screened after the intervention (as a continuous variable from 1 [not intending to be screened] to 15 [strongly intending to be screened]) adjusting for intentions to be screened at baseline as well as age, educational attainment, and race/ethnicity.


Secondary Outcome Measures :
  1. Screening intentions within risk groups [ Time Frame: 1 week ]
    The investigators will us the paired t-test (or Wilcoxon Signed Rank Test if data are not normal) to examine the differences in intentions to be screened with mammography after the intervention within each risk group.

  2. Knowledge of the pros and cons of mammography screening [ Time Frame: 1 week ]
    The investigators will use the paired t-test (or Wilcoxon Signed Rank Test when data are not normal) to examine the effect of the intervention on participants' knowledge of the benefits and risks of mammography screening (mean score on knowledge test)

  3. Decisional conflict scale [ Time Frame: 1 week ]
    The DCS is a validated 16 item scale to measure uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making (Cronbach's alpha=0.78 to 0.92); scores range 0-100 and lower scores indicate less conflict.

  4. Difference in PCP discussion of breast cancer risk [ Time Frame: 1 week ]
    The investigators will use McNemar's test to examine patient reports of PCP discussions of breast cancer risk [yes/no] before and after the intervention.

  5. Difference in PCP discussion of pros/cons of mammography screening [ Time Frame: 1 week ]
    The investigators will use McNemar's test to examine patient report of PCP discussion of the pros and cons of mammography screening [yes/no] before and after the intervention.

  6. PCP discussion of breast cancer prevention medications [ Time Frame: 1 week ]
    The investigators will use descriptive statistics to examine the proportion of women with >1.7% 5-year breast cancer risk that report discussing breast cancer prevention medications with their PCP.

  7. PCP documentation of discussions of breast cancer medications [ Time Frame: 1 week ]
    The investigators will use descriptive statistics to examine the proportion of women with >1.7% 5-year breast cancer whose PCPs document discussions about breast cancer prevention medications on the day of the visit.

  8. Prescription of breast cancer prevention medications [ Time Frame: 6 months ]
    The investigators will use descriptive statistics to report proportion of women with >1.7% 5-year breast cancer risk who were prescribed breast cancer prevention medications through review of medication lists

  9. Time until breast screening MRI [ Time Frame: 6 months ]
    The investigators will use the log-rank test to examine time until breast screening MRI among women with >20% lifetime breast cancer risk by lifetime breast cancer risk score as a continuous variable.

  10. Referral to genetic counseling [ Time Frame: 6 months ]
    The investigators will examine the proportion of women who meet NCCN criteria for genetic counseling for a BRCA mutation that are referred for genetic counseling

  11. Attended genetic counseling [ Time Frame: 6 months ]
    The investigators will examine the proportion of women who meet NCCN criteria for genetic counseling for a BRCA mutation that meet with a genetic counselor

  12. Time until next mammogram after intervention [ Time Frame: 21 months ]
    The investigators will examine the time until next mammogram after our intervention stratified by women's 5-year risk of breast cancer (based on the Breast Cancer Risk Assessment Tool [BCRAT]/Tice model [whichever is higher]) using the log-rank test.

  13. Date of mammogram(s) after intervention [ Time Frame: 21 months ]
    The investigators will document the date of mammogram performed on any women in the study during the study's follow-up time period.

  14. Type of mammogram(s) after intervention [ Time Frame: 21 months ]
    The investigators will document the type of mammogram performed on any women in the study during the study's follow-up time period.

  15. No mammogram after intervention [ Time Frame: 21 months ]
    The investigators will perform a chart review of women not identified as having had a mammogram during the study's follow-up time period to confirm that there is no mammogram noted in their screening sheet.

  16. Risk report acceptability [ Time Frame: 1 week ]
    The investigators will ask whether patients and PCPs found our risk report acceptable and/or helpful.

  17. PCP facilitators and barriers [ Time Frame: up to 24 months ]
    The investigators will examine facilitators and/or barriers noted by PCPs when assessing women's breast cancer risk and managing women based on their risk.

  18. PCP risk of malpractice/litigation [ Time Frame: up to 24 months ]
    The investigators will ask whether PCPs feel that our intervention would help lower their risk of malpractice litigation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180086


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Mara Schonberg, MD, MPH Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mara Schonberg, Principle Investigator - Staff Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03180086    
Other Study ID Numbers: 2017P000129
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mara Schonberg, Beth Israel Deaconess Medical Center:
Breast cancer risk
Primary Care
Women
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases