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NCT03470402 · ClinicalTrials.gov registry record · NA
Decision Support for BRCA Testing in Ethnically Diverse Women
A NA study of Breast Cancer and Ovarian Cancer, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 1
- Study location
NCT03470402: Completed NA study of Breast Cancer and Ovarian Cancer, sponsored by Columbia University.
NCT03470402 is a NA study of Breast Cancer and Ovarian Cancer that has completed, run by Columbia University. The registered enrollment target is 276 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03470402, a NA study of Breast Cancer and Ovarian Cancer, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider electronic health record (EHR) notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.
Primary Outcome
The primary endpoint is to determine the uptake of genetic counseling for HBOC syndrome by 6 months in the intervention arm (RealRisks Decision Aid and BNAV toolbox) compared to the control arm (Standard educational materials)
Conditions Studied
Interventions
- OTHER RealRisks
- OTHER BNAV
- OTHER iNYP
- OTHER Standard Educational Material
- OTHER High-Risk Message
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2017-12-13 |
| Est. Completion | 2020-08-17 |
| Phase | NA |
What the finished NCT03470402 record still lists
NCT03470402 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which RealRisks is the first listed.
NCT03470402 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03470402 about?
NCT03470402 is a clinical study titled "Decision Support for BRCA Testing in Ethnically Diverse Women". The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (B...
What is the current status of trial NCT03470402?
This trial is currently completed. It is a NA study. The enrollment target is 276 participants. The study started on 2017-12-13. Estimated completion is 2020-08-17.
What conditions does trial NCT03470402 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, BRCA1 Mutation, BRCA2 Mutation.
What interventions are being tested in trial NCT03470402?
The interventions under investigation include: RealRisks (OTHER), BNAV (OTHER), iNYP (OTHER), Standard Educational Material (OTHER), High-Risk Message (OTHER).
Who is sponsoring clinical trial NCT03470402?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03470402 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03470402's enrollment target sits among peer trials
276 300th of 1224 higher than 923 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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