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Peer Support for Young Women at High Risk for Breast Cancer

N/A
Recruiting
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Must be able to speak English or Spanish and provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial will help assess how well a 3-session peer coach-led telephone counseling intervention helps young adult female relatives of carriers of BRCA1/2 manage their distress and make decisions about their health.

Who is the study for?
This trial is for young adult women aged 21-30 who are biological relatives of someone with a BRCA1/2 mutation, indicating high breast cancer risk. Participants must be able to speak English or Spanish and provide informed consent. Men or women carriers of the mutation can also join if they're over 18.
What is being tested?
The study compares a telephone counseling intervention led by peer coaches against usual care navigation to community support for hereditary cancer. It aims to see how this affects distress, decision-making, and uptake of genetic counseling in participants over time.
What are the potential side effects?
Since this trial involves counseling sessions rather than medical treatments, traditional side effects like those seen with medications are not expected. However, discussing sensitive topics may cause emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can speak English or Spanish and can give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cancer-related distress
Decisional conflict
Genetic counseling

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PeACE peer coaching armExperimental Treatment1 Intervention
Behavioral, PeACE, PeACE consists of 3 streamlined 30-minute psychosocial telephone counseling sessions delivered by a well-trained peer coach. Coaches are lay YARs from HBOC families demonstrating good knowledge, communication skills, and protocol mastery.
Group II: Community peer coaching armActive Control1 Intervention
Behavioral, usual care, Participants in the usual care arm will receive navigation to peer support with a range of community groups who provide these services.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
136,650 Total Patients Enrolled

Media Library

Community peer coaching Clinical Trial Eligibility Overview. Trial Name: NCT04248257 — N/A
Breast Cancer Risk Research Study Groups: Community peer coaching arm, PeACE peer coaching arm
Breast Cancer Risk Clinical Trial 2023: Community peer coaching Highlights & Side Effects. Trial Name: NCT04248257 — N/A
Community peer coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248257 — N/A
~122 spots leftby Dec 2025
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