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Quantitative Genetic Counseling 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My doctor says I am fit for surgery.

Select...

I am between 18 and 79 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breast

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

Secondary outcome measures

Contralateral Prophylactic Mastectomy (CPM) Rate

Genetic Testing Satisfaction

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

+1 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,586 Total Patients Enrolled

141 Trials studying Breast Cancer

22,217 Patients Enrolled for Breast Cancer

Myriad Genetics, Inc.Industry Sponsor

16 Previous Clinical Trials

4,989 Total Patients Enrolled

1 Trials studying Breast Cancer

203 Patients Enrolled for Breast Cancer

Anna Weiss, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Quantitative Genetic Counseling Clinical Trial Eligibility Overview. Trial Name: NCT04245176 — N/A

Breast Cancer Research Study Groups: STANDARD GENETIC COUNSELING, Quantitative Genetic Counseling

Breast Cancer Clinical Trial 2023: Quantitative Genetic Counseling Highlights & Side Effects. Trial Name: NCT04245176 — N/A

Quantitative Genetic Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245176 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study recruiting participants who are younger than fifty years of age?

"In order to be considered for enrollment, the applicant must have reached 18 years of age and not exceed 79."

Answered by AI

How many participants is this trial involving?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting patients - the trial was initially made available on January 31st 2020 and last modified September 26th 2022. 450 participants need to be enrolled from one single site."

Answered by AI

Can I join the experiment and take part in the trial?

"This research seeks to enroll 450 individuals with breast cancer of varying ages, between 18 and 79. However, participants must be able to make decisions regarding their own surgery independently, have medical clearance for the procedure and fall within the specified age range."

Answered by AI

Is this experiment actively seeking participants?

"Affirmative. Clinicaltrials.gov reports that this trial, whose initial posting was on January 31st 2020, is currently seeking 450 participants from a single location."

Answered by AI

To what end is this clinical research effort aiming?

"This month-long trial has two primary goals: assessing alterations in patients' predisposition to opt for a bilateral mastectomy via an internally devised survey and comparing CPM rates between those who receive quantitative versus standard genetic counseling. Secondary objectives include measuring patient satisfaction with the delivery of results through either type of counselling on the GTS, as well as monitoring decisional regret regarding testing and surgery selections made by participants under both types of counsel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetic Testing for All Breast Cancer Patients (GET FACTS)

Tari King, MD 2020. "Genetic Testing for All Breast Cancer Patients (GET FACTS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04245176.

All > Breast Cancer Boston