Informed Implementation of Breast Density Reporting

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.

Study Overview

• Status: Completed
• Conditions: Breast Density, Breast Cancer Prevention
• Intervention / Treatment: Behavioral: Vidscrip educational video

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vidscrip educational video; Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result	Behavioral: Vidscrip educational video; Vidscrip educational video provide to women
No Intervention: Standard of care; 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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Jennifer S Haas, MD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016P001411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No