Breast DensityNCT03029286
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
A study testing Personalized Web Intervention Arm in people with Breast Density and Breast Cancer Female, run by Georgetown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 years, women only
- Conditions the study is for
- Breast Density, Breast Cancer Female
- What is being tested?
- Personalized Web Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 995 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 28124
About this study
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.
Read the detailed description
Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.
- Conditions
- Breast Density, Breast Cancer Female
- Being tested
- Usual Care Arm, Personalized Web Intervention Arm
- Keywords
- Breast Cancer, Breast Density
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care ArmBehavioural
Health information provided by the American Cancer Society Website
Personalized Web Intervention ArmBehavioural
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Distress Related to Cancer Risk
Distress was measured with the item, "Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress)."
Measured: 6 weeks and 12 months
Number of Participants Receiving Breast MRI
Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 995 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Principal investigator, Suzanne C. O'Neill, Georgetown University
- Investigators
- Suzanne C O'Neill, PhD, Principal investigator, Georgetown University/Lombardi Comprehensive Cancer CenterKaren Wernli, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029286
- Sponsor's protocol ID
- 2015-0687
- Status last verified
- Apr 2025
- First submitted
- 18 Jan 2017
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28257920Mahorter 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.
PubMed 31977078Wernli 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.
PubMed 33482952Wernli 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.
PubMed 33554037Bowles 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.
PubMed 34582721Conley 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.
PubMed 34813048Wernli 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.
PubMed 35723793
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
- ClinicalTrials.gov ID
- NCT03029286
- Acronym / sponsor ID
- 2015-0687
- Conditions
- Breast Density, Breast Cancer Female
- Keywords
- Breast Cancer, Breast Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 995 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Web Intervention Arm | Experimental | Behavioral: Personalized Web Intervention ArmWomen will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
| Usual Care Arm | Active comparator | Behavioral: Usual Care ArmWomen 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care ArmHealth information provided by the American Cancer Society Website | Behavioural | Usual Care Arm |
| Personalized Web Intervention ArmWomen will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. | Behavioural | Personalized Web Intervention Arm |
Primary outcome
Number of Participants Taking Chemoprevention at 12 Months
Time frame: 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.
2 secondary outcomes
Distress Related to Cancer Risk
Time frame: 6 weeks and 12 months
Number of Participants Receiving Breast MRI
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28257920Knerr 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.
- Results publication: PubMed 31977078Mahorter 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.
- Results publication: PubMed 33482952Wernli 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.
- Results publication: PubMed 33554037Wernli 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.
- Results publication: PubMed 34582721Bowles 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.
- Results publication: PubMed 34813048Conley 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.
- Derived from this study: PubMed 35723793Wernli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne C O'Neill, PhD principal investigator
Georgetown University/Lombardi Comprehensive Cancer Center
Karen Wernli, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Web Intervention Arm in people with Breast Density and Breast Cancer Female, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Taking Chemoprevention at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029286, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.