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OpenTrials
Completed

NCT Number: NCT02986360

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vidscrip educational video

Behavioral

Vidscrip educational video provide to women

Primary outcomes

  1. Knowledge of overall breast cancer risk

    Time frame: 1 month

    electronic questionnaire developed by research staff

  2. Knowledge of breast density

    Time frame: 1 month

    electronic questionnaire developed by research staff

Secondary outcomes

  1. Observed use of additional screening

    Time frame: 9 months of index mammogram

    Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.