Breast Cancer Risk Assessment in Women Aged 40-49

NCT03180086 | Completed

• 1 other identifier: 2017P000129
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer risk; Primary Care; Women

Outcome Measures

Primary Outcomes (1)

• Screening intentions

  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.

  1 week

Secondary Outcomes (18)

• Screening intentions within risk groups

  1 week

• Knowledge of the pros and cons of mammography screening

  1 week

• Decisional conflict scale

  1 week

• Difference in PCP discussion of breast cancer risk

  1 week

• Difference in PCP discussion of pros/cons of mammography screening

  1 week

Study Arms (1)

Breast cancer risk report

EXPERIMENTAL

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

Interventions

Breast cancer risk report OTHER

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.

Breast cancer risk report

Eligibility Criteria

• Age: 40 Years - 49 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 32828322 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mara Schonberg, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator - Staff Physician

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: July 1, 2017
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)