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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met