Informed Implementation of Breast Density Reporting

NCT ID: NCT02986360

Last Updated: 2018-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-11-30

Brief Summary

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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

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Conditions

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Breast Density, Breast Cancer Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Vidscrip educational video

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

Group Type ACTIVE_COMPARATOR

Vidscrip educational video

Intervention Type BEHAVIORAL

Vidscrip educational video provide to women

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vidscrip educational video

Vidscrip educational video provide to women

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jennifer S. Haas, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer S Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30091121 (View on PubMed)

Other Identifiers

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2016P001411

Identifier Type: -

Identifier Source: org_study_id

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