Clinical trial · Interventional
Breast Cancer Risk Assessment in Women Aged 40-49
NCT03180086CI-TRIAL-00071313completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast cancer risk report | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer risk report
- description
- 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.
- interventionNames
- Other: Breast cancer risk report
Primary outcomes (1)
- measure
- Screening intentions
- timeFrame
- 1 week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSchonberg 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