N/A
N=995
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Breast Density · Breast Cancer Female
Bottom Line
View on ClinicalTrials.gov: NCT03029286 ↗Enrolled (actual)
995
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants Taking Chemoprevention at 12 Months — 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care Arm (Behavioral); Personalized Web Intervention Arm (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Georgetown University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Taking Chemoprevention at 12 Months |
1; 1 | — |
| SECONDARY Distress Related to Cancer Risk |
0.72; 0.61; 0.36; 0.47 | — |
| SECONDARY Number of Participants Receiving Breast MRI |
16; 3 | — |
Summary
This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.
Eligibility Criteria
Inclusion Criteria
- Women, aged 40-69
- Enrolled at Group Health
- Have had a negative mammogram as part of their routine care
- Either (a) an intermediate 5-year risk (>1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense breasts utilizing the Breast Cancer Surveillance Consortium Risk Calculator (http://tools.bcsc-scc.org/BC5yearRisk/)
- Women must also have a valid email address.
Exclusion Criteria
- Not able to speak and read English
- History of LCIS
- Prior cancer diagnosis (including DCIS)
- Known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling
- Do not want to be contacted for research
- Have previously participated in intervention development activities
- Dis-enrolled from health plan between mammogram and start of recruitment.
Data sourced from ClinicalTrials.gov (NCT03029286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.