Informed Implementation of Breast Density Reporting

Mass General Brigham

Status: Completed

Conditions: Breast Density, Breast Cancer Prevention

Treatments: Behavioral: Vidscrip educational video

Study type: Interventional

Funder types: Other

Identifiers

NCT02986360

2016P001411

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Vidscrip educational video

Active Comparator group

Description:

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

Treatment:

Behavioral: Vidscrip educational video

Standard of care

No Intervention group

Description:

Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density