Clinical trial · Interventional
Informed Implementation of Breast Density Reporting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Density, Breast Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vidscrip educational video | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vidscrip educational video
- description
- Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result
- interventionNames
- Behavioral: Vidscrip educational video
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density
Primary outcomes (2)
- measure
- Knowledge of overall breast cancer risk
- timeFrame
- 1 month
- description
- electronic questionnaire developed by research staff
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHaas 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. PMID 30091121