Skip to content

Informed Implementation of Breast Density Reporting

Informed Implementation of Breast Density Reporting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02986360
Enrollment
500
Registered
2016-12-08
Start date
2017-05-01
Completion date
2017-11-30
Last updated
2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Density, Breast Cancer Prevention

Brief summary

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.

Interventions

BEHAVIORALVidscrip educational video

Vidscrip educational video provide to women

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of overall breast cancer risk1 monthelectronic questionnaire developed by research staff
Knowledge of breast density1 monthelectronic questionnaire developed by research staff

Secondary

MeasureTime frameDescription
Observed use of additional screening9 months of index mammogramAdditional screening tests (ultrasound or MRI) extracted from patient's electronic medical record

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026