← Back to Search

Genetic Testing for Breast Cancer

N/A

Waitlist Available

Led By Anna Weiss, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are medically cleared for surgery

Patients must be at least age 18 but under 79

Must not have

Bilateral breast cancer

Known medical or surgical contraindication to contralateral mastectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the two methods to see which is more effective in helping individuals make surgical decisions about their breast cancer.

Who is the study for?

This trial is for English-speaking adults aged 18-78 with a new breast cancer diagnosis who are cleared for surgery and considering genetic testing. It's not for those with metastatic or bilateral breast cancer, previous breast cancers, certain other malignancies, or prior broad-based panel genetic testing.

What is being tested?

The study compares two types of genetic counseling: 'Quantitative' which uses tables and graphs to guide discussion, and the 'Standard' method. The goal is to see how these affect surgical decisions in newly diagnosed breast cancer patients.

What are the potential side effects?

Since this trial involves counseling methods rather than medications, traditional side effects like you might expect from drugs aren't applicable here. However, participants may experience emotional or psychological responses to the information they receive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My doctor says I am fit for surgery.

Select...

I am between 18 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have cancer in both of my breasts.

Select...

I have a health condition that prevents me from having surgery on the opposite breast.

Select...

I have been diagnosed with breast cancer before.

Select...

My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Breast

Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question

Secondary study objectives

Contralateral Prophylactic Mastectomy (CPM) Rate

Genetic Testing Satisfaction

Level of anxiety among participants, as measured by the PROMIS anxiety scale

+1 more

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: Quantitative Genetic CounselingExperimental Treatment1 Intervention

The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups: -- Quantitative genetic counseling: Discussion is guided by tables and graphs.

Group II: STANDARD GENETIC COUNSELINGActive Control1 Intervention

The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups: -- Standard genetic counseling: Standard of care discussion

0 / 6Eligibility criteria met