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ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03029286
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Suzanne C. O'Neill, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Breast Density Breast Cancer Female Behavioral: Usual Care Arm Behavioral: Personalized Web Intervention Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 995 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized Web Intervention Arm
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
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Active Comparator: Usual Care Arm
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
Health information provided by the American Cancer Society Website




Primary Outcome Measures :
  1. Uptake of chemoprevention gathered via health plan pharmacy records at 12 months [ Time Frame: 12 months ]
    Chemoprevention (raloxifine or tamoxifen) gathered via health plan pharmacy records at 12 months


Secondary Outcome Measures :
  1. Distress gathered via self-report distress thermometer at 6-weeks and 12 months after recruitment [ Time Frame: 6 weeks and 12 months ]
    Distress via self-report distress thermometer

  2. Breast MRI gathered via health plan records at 12 months [ Time Frame: 12 months ]
    Use of Breast MRI gathered via health plan records



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029286


Locations
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United States, Washington
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 28124
Sponsors and Collaborators
Georgetown University
Kaiser Permanente
Investigators
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Principal Investigator: Suzanne C O'Neill, PhD Georgetown University/Lombardi Comprehensive Cancer Center
Principal Investigator: Karen Wernli, PhD Kaiser Permanente
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Suzanne C. O'Neill, Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03029286    
Other Study ID Numbers: 2015-0687
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suzanne C. O'Neill, Georgetown University:
Breast Cancer
Breast Density
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases