Clinical trial · Interventional
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
NCT03029286CI-TRIAL-00089081completedN/AResults postedClinicalTrials.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)
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.
Conditions
Conditions (2)
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 Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Density | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized Web Intervention Arm | Behavioral | — | UNRESOLVED |
| Usual Care Arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Personalized Web Intervention Arm
- description
- Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
- interventionNames
- Behavioral: Personalized Web Intervention Arm
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Arm
- description
- Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density.
- interventionNames
- Behavioral: Usual Care Arm
Primary outcomes (1)
- measure
- Number of Participants Taking Chemoprevention at 12 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDKnerr S, Wernli KJ, Leppig K, Ehrlich K, Graham AL, Farrell D, Evans C, Luta G, Schwartz MD, O'Neill SC. A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system. Contemp Clin Trials. 2017 May;56:25-33. doi: 10.1016/j.cct.2017.02.009. Epub 2017 Feb 28. PMID 28257920
- RESULTMahorter SS, Knerr S, Bowles EJA, Wernli KJ, Gao H, Schwartz MD, O'Neill SC. Prior breast density awareness, knowledge, and communication in a health system-embedded behavioral intervention trial. Cancer. 2020 Apr 15;126(8):1614-1621. doi: 10.1002/cncr.32711. Epub 2020 Jan 24. PMID 31977078
- RESULTWernli KJ, Bowles EA, Knerr S, Leppig KA, Ehrlich K, Gao H, Schwartz MD, O'Neill SC. Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial. Perm J. 2020 Dec;24:1-4. doi: 10.7812/TPP/19.205. PMID 33482952
- RESULTWernli KJ, Knerr S, Li T, Leppig K, Ehrlich K, Farrell D, Gao H, Bowles EJA, Graham AL, Luta G, Jayasekera J, Mandelblatt JS, Schwartz MD, O'Neill SC. Effect of Personalized Breast Cancer Risk Tool on Chemoprevention and Breast Imaging: ENGAGED-2 Trial. JNCI Cancer Spectr. 2021 Jan 14;5(1):pkaa114. doi: 10.1093/jncics/pkaa114. eCollection 2021 Feb. PMID 33554037
- RESULTBowles EJA, O'Neill SC, Li T, Knerr S, Mandelblatt JS, Schwartz MD, Jayasekera J, Leppig K, Ehrlich K, Farrell D, Gao H, Graham AL, Luta G, Wernli KJ. Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density. J Womens Health (Larchmt). 2021 Nov;30(11):1529-1537. doi: 10.1089/jwh.2021.0053. Epub 2021 Sep 28. PMID 34582721
- RESULTConley CC, Wernli KJ, Knerr S, Li T, Leppig K, Ehrlich K, Farrell D, Gao H, Bowles EJA, Graham AL, Luta G, Jayasekera J, Mandelblatt JS, Schwartz MD, O'Neill SC. Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial. J Cancer Educ. 2023 Feb;38(1):292-300. doi: 10.1007/s13187-021-02114-y. Epub 2021 Nov 23.