Informed Implementation of Breast Density Reporting

Study Overview
=================
Brief Summary
-----------------
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. 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.

Official Title
-----------------
Informed Implementation of Breast Density Reporting

Conditions
-----------------
Breast Density, Breast Cancer Prevention

Intervention / Treatment
-----------------
* Behavioral: Vidscrip educational video


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vidscrip educational video<br>Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result | Behavioral: Vidscrip educational video<br>* Vidscrip educational video provide to women<br>|
| No Intervention: Standard of care<br>Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of overall breast cancer risk | electronic questionnaire developed by research staff | 1 month | 
| Knowledge of breast density | electronic questionnaire developed by research staff | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed use of additional screening | Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record | 9 months of index mammogram |