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Peer Support For Young Adult Women With High Breast Cancer Risk
NCT04248257 · View on ClinicalTrials.gov ↗
Study Summary
This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. Study aims are to 1) Assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested YARs, 2) Identify YARs most likely to engage with and benefit from the intervention, 3) Understand intervention mechanisms. Participants will complete interviews at baseline, 1, 6, and 12 months.
Conditions Studied
Interventions
- BEHAVIORAL PeACE
- BEHAVIORAL Community peer coaching
Study Locations (6)
District of Columbia
- Georgetown University — Washington D.C.
Massachusetts
- Dana Farber Cancer Center — Boston
New Jersey
- Hackensack University Medical Center — Hackensack
New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- University of Texas Southwestern Medical Center — Dallas
Washington
- University of Washington — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04248257
The ClinicalTrials.gov registry entry for NCT04248257 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer Risk appearing as the primary indexed condition, and to 2 interventions — of which PeACE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04248257 reports 6 study locations spanning 6 distinct geographic areas — top geographies include District of Columbia, Massachusetts, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04248257 about?
NCT04248257 is a clinical study titled "Peer Support For Young Adult Women With High Breast Cancer Risk". This trial will recruit young adult female relatives (YARs) of male or female carriers of BRCA1/2. YARs who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community or...
What is the current status of trial NCT04248257?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 560 participants. The study started on 2020-07-15. Estimated completion is 2026-12.
What conditions does trial NCT04248257 study?
This clinical trial studies the following conditions: Breast Cancer Risk. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04248257?
The interventions under investigation include: PeACE (BEHAVIORAL), Community peer coaching (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04248257?
This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04248257 being conducted?
This trial has 6 study locations across District of Columbia, Massachusetts, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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