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NCT04248257 · ClinicalTrials.gov registry record · NA

Peer Support For Young Adult Women With High Breast Cancer Risk

A NA study of Breast Cancer Risk, sponsored by Georgetown University.

Active
Registry status
NA
Development phase
560
Enrollment target
6
Study locations

NCT04248257: Active NA study of Breast Cancer Risk, sponsored by Georgetown University.

NCT04248257 is a NA study of Breast Cancer Risk that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 560 participants, below the 6,595-participant average among 4 other Breast Cancer Risk trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04248257, a NA study of Breast Cancer Risk, is active but no longer recruiting, sponsored by Georgetown University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
560 participants
Enrollment target
6
Study locations

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.

Primary Outcome

Cancer-related distress about hereditary breast and ovarian cancer risk at 12 months, gathered via self-report using the Impact of Events Scale, a 15 item measure scored on a 0-3 scale (0-45) with higher scores meaning higher distress

Conditions Studied

Breast Cancer Risk

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

FieldValue
Enrollment Target 560 participants
Start Date 2020-07-15
Est. Completion 2026-12
Phase NA
Georgetown University

227 total trials

What the registry record for NCT04248257 still lists

NCT04248257 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, below the 6,595-participant average among 4 other Breast Cancer Risk trials with a reported enrollment target (92% lower).

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.

NCT04248257 lists 6 locations in 6 states (District of Columbia, Massachusetts, New Jersey).

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.

What interventions are being tested in trial NCT04248257?

The interventions under investigation include: PeACE (BEHAVIORAL), Community peer coaching (BEHAVIORAL).

Who is sponsoring clinical trial NCT04248257?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

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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Related registry views

Source: ClinicalTrials.gov NCT04248257, the US trial registry maintained by the National Library of Medicine. NCT04248257 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.