Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
500 participants
INTERVENTIONAL
2017-05-01
2017-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening \[i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer\], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Automated Breast Ultrasound Screening
NCT02650778
Communicating Objective Risk for Personalized Decision Making About Mammography
NCT01686360
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
NCT01928992
Trial of a Mammography Decision Aid for Women Aged 75 and Older
NCT02198690
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
NCT03029286
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vidscrip educational video
Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result
Vidscrip educational video
Vidscrip educational video provide to women
Standard of care
Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vidscrip educational video
Vidscrip educational video provide to women
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* normal mammogram result
* no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer
* must have email account
Exclusion Criteria
* prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer
* no email
40 Years
75 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer S. Haas, MD
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer S Haas, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Haas JS, Giess CS, Harris KA, Ansolabehere J, Kaplan CP. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification. J Gen Intern Med. 2019 Apr;34(4):591-597. doi: 10.1007/s11606-018-4622-4. Epub 2018 Aug 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016P001411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.