Breast Density, Breast Cancer Prevention Clinical Trial
Official title:
Informed Implementation of Breast Density Reporting
| Verified date | September 2018 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
1. To develop brief informational videos, Vidscrips, that can be sent to women following
their mammogram to provide personalized information that integrates breast density with
overall breast cancer risk, and provides information about additional care
recommendations and talking tips for conversations with the health care providers.
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | November 30, 2017 |
| Est. primary completion date | November 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - undergoing screening mammography at participating hospital facility - normal mammogram result - no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer - must have email account Exclusion Criteria: - non-English speaking - prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer - no email |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Knowledge of overall breast cancer risk | electronic questionnaire developed by research staff | 1 month | |
| Primary | Knowledge of breast density | electronic questionnaire developed by research staff | 1 month | |
| Secondary | Observed use of additional screening | Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record | 9 months of index mammogram |