NCT03029286

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
995

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
6 years until next milestone

Results Posted

Study results publicly available

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

January 18, 2017

Results QC Date

March 20, 2025

Last Update Submit

April 26, 2025

Conditions

Breast DensityBreast Cancer Female

Keywords

Breast CancerBreast Density

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Taking Chemoprevention at 12 Months

    Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months.

    12 months

Secondary Outcomes (2)

  • Distress Related to Cancer Risk

    6 weeks and 12 months

  • Number of Participants Receiving Breast MRI

    12 months

Study Arms (2)

Personalized Web Intervention Arm

EXPERIMENTAL

Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Behavioral: Personalized Web Intervention Arm

Usual Care Arm

ACTIVE COMPARATOR

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.

Behavioral: Usual Care Arm

Interventions

Usual Care ArmBEHAVIORAL

Health information provided by the American Cancer Society Website

Usual Care Arm
Personalized Web Intervention ArmBEHAVIORAL

Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Personalized Web Intervention Arm

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 28124, United States

Location

Related Publications (7)

  • Knerr 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: 28257920BACKGROUND

  • Mahorter 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: 31977078RESULT

  • Wernli 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: 33482952RESULT

  • 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. 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: 33554037RESULT

  • Bowles 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: 34582721RESULT

  • Conley 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.

    PMID: 34813048RESULT

  • Wernli KJ, Smith RE, Henderson LM, Zhao W, Durham DD, Schifferdecker K, Kaplan C, Buist DSM, Kerlikowske K, Miglioretti DL, Onega T, Alsheik NH, Sprague BL, Jackson-Nefertiti G, Budesky J, Johnson D, Tosteson ANA. Decision quality and regret with treatment decisions in women with breast cancer: Pre-operative breast MRI and breast density. Breast Cancer Res Treat. 2022 Aug;194(3):607-616. doi: 10.1007/s10549-022-06648-7. Epub 2022 Jun 20.

    PMID: 35723793DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Suzanne O'Neill, PhD
Organization
Georgetown University
sco4@georgetown.edu
202-687-0869

Study Officials

  • Suzanne C O'Neill, PhD

    Georgetown University/Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Karen Wernli, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 24, 2017

Study Start

February 15, 2017

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

April 30, 2025

Results First Posted

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)