Informed Implementation of Breast Density Reporting

Not Applicable

Completed

• Conditions: Breast Density, Breast Cancer Prevention
• Interventions: Behavioral: Vidscrip educational video

• Registration Number: NCT02986360
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Study Start: 2017-05-01
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vidscrip educational video	Vidscrip educational video	Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result

Primary Outcome Measures

Name	Time	Method
Knowledge of overall breast cancer risk	1 month	electronic questionnaire developed by research staff
Knowledge of breast density	1 month	electronic questionnaire developed by research staff

Secondary Outcome Measures

Name	Time	Method
Observed use of additional screening	9 months of index mammogram	Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States