NCT02986360

Informed Implementation of Breast Density Reporting

Completed NA Last updated 21 September 2018

What this trial tests

NA trial testing Vidscrip educational video in Breast Density, Breast Cancer Prevention in 500 participants. Completed in 30 November 2017.

Timeline

1 May 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	500
Start date	1 May 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across United States

Drugs / interventions tested

• Vidscrip educational video

Conditions studied

• Breast Density, Breast Cancer Prevention — all drugs for Breast Density, Breast Cancer Prevention →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 40 to 75, female only, with Breast Density, Breast Cancer Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.
   Haas JS, Giess CS, Harris KA, Ansolabehere J, et al · · 2019 · cited 16× · PMID 30091121 · DOI 10.1007/s11606-018-4622-4