Genetic Testing for Breast Cancer

AW
TK
Overseen ByTara King, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a new genetic counseling method might influence surgical decisions for individuals recently diagnosed with breast cancer. Participants will undergo genetic testing and receive guidance through either standard genetic counseling or a new approach using tables and graphs, known as quantitative genetic counseling. The study targets those who are newly diagnosed, proficient in English, and prepared to make surgical decisions. Eligible participants should not have had breast cancer previously and must be cleared for surgery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance decision-making tools for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these genetic counseling methods are safe?

Research has shown that genetic counseling, whether conducted traditionally or with charts and graphs, is generally safe and well-received by patients. In past studies, participants reported high satisfaction with genetic counseling. For instance, one study found that 94.9% of participants felt their questions about hereditary breast cancer were answered after counseling and testing. This suggests that the process is not only informative but also easy for patients to navigate.

These trials focus on counseling methods, which involve discussion and education, not medical procedures. Therefore, patients need not worry about physical side effects. The counseling helps patients understand their genetic test results, guiding important health decisions. Based on available data, these methods appear safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different approaches to genetic counseling for breast cancer, which could revolutionize patient understanding and decision-making. Unlike standard genetic counseling, which involves a typical discussion format, quantitative genetic counseling uses tables and graphs to guide the conversation. This visual approach could make complex genetic information more accessible and easier to understand for patients, potentially leading to more informed choices about their health. By comparing these two methods, researchers hope to identify a counseling technique that enhances patient comprehension and satisfaction.

What evidence suggests that these genetic counseling methods are effective for breast cancer?

This trial will compare two methods of genetic counseling for breast cancer patients: Standard Genetic Counseling and Quantitative Genetic Counseling. Research has shown that genetic counseling aids breast cancer patients in making treatment decisions. Studies have found that using charts and graphs during genetic counseling, as in the Quantitative Genetic Counseling arm of this trial, helps patients better understand their test results. This understanding can lead to more informed choices about surgery. Specifically, one study found that this method can speed up receiving test results by up to 85%, which is crucial for timely decision-making. Overall, patients report high satisfaction with genetic counseling, indicating it is a valuable part of managing their treatment.13678

Who Is on the Research Team?

TK

Tara King, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been newly diagnosed with breast cancer and am considering genetic testing.
I can make my own decisions about surgery.
My doctor says I am fit for surgery.
See 1 more

Exclusion Criteria

I have cancer in both of my breasts.
I have a health condition that prevents me from having surgery on the opposite breast.
I have had genetic testing done, but my BRCA1/2 results were negative.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Counseling

Participants receive genetic testing and are placed into either standard or quantitative genetic counseling groups

1 month
1 visit (in-person)

Follow-up

Participants are monitored for changes in risk assessment, anxiety levels, and satisfaction with genetic counseling

6 months
Multiple visits (in-person and virtual)

Optional Extension

Participants may opt into an extension of the study for further monitoring and counseling

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Quantitative Genetic Counseling
  • Standard Genetic Counseling
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Quantitative Genetic CounselingExperimental Treatment1 Intervention
Group II: STANDARD GENETIC COUNSELINGActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Myriad Genetics, Inc.

Industry Sponsor

Trials
18
Recruited
5,700+

Published Research Related to This Trial

The demand for cancer genetic counseling is increasing, necessitating the exploration of alternative service delivery models like telephone counseling, telegenetics, and group counseling to improve access to care.
While preliminary research suggests these alternative models may be acceptable to patients and improve access, further studies are needed to evaluate their long-term effectiveness and outcomes compared to traditional in-person counseling.
Alternate Service Delivery Models in Cancer Genetic Counseling: A Mini-Review.Buchanan, AH., Rahm, AK., Williams, JL.[2022]
The establishment of satellite clinics and educational programs significantly improved clinician knowledge about cancer genetic counseling, leading to better quality referrals for patients, with 88% of patients attending their appointments.
In a predominantly Latina clinic population, 71.4% of patients had cancer, and 17 families were identified with genetic mutations, indicating that targeted genetic counseling can effectively identify at-risk individuals and potentially reduce cancer morbidity in underserved communities.
If we build it ... will they come?--establishing a cancer genetics services clinic for an underserved predominantly Latina cohort.Ricker, C., Lagos, V., Feldman, N., et al.[2022]
A new model of genetic counseling (GC) that includes a 20-minute presentation before a telephone call significantly reduced the time needed for pre-test GC, averaging 19 minutes compared to 46 minutes for traditional in-person counseling.
This modified GC model was found to be non-inferior to traditional methods in terms of psychosocial outcomes like cancer-specific distress and satisfaction, making it an efficient alternative to meet the increasing demand for genetic testing.
Modified panel-based genetic counseling for ovarian cancer susceptibility: A randomized non-inferiority study.McCuaig, JM., Tone, AA., Maganti, M., et al.[2019]

Citations

Genetic counseling and testing for females at elevated risk for ...Genetic counseling and testing have an important role in the care of patients at elevated risk for breast cancer. However, conventional pre- and post-test ...
Systematic evidence review and meta-analysis of ...We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.
Patient Outcomes Associated with Group and Individual ...Participants in both the individual and group formats reported high satisfaction scores on the Genetic Counseling Satisfaction Scale. Study results suggest that ...
BRCA genetic testing and counseling in breast cancerAnother study in patients with breast cancer measured an 85% reduction in time to test result using the mainstream model compared with the ...
The breast cancer genetic testing experience: probing the ...Of the 22 women interviewed, 11 (50%) had positive GT results, 2 (9.1%) with a BRCA1/2 PV, and 9 (40.9%) with variants of uncertain significance ...
BRCA Gene Changes: Cancer Risk and Genetic TestingThe risks of developing breast and ovarian cancer are markedly increased in people who inherit a harmful change in BRCA1 or BRCA2.
A comparison of cancer risk assessment and testing ...Data analysis​​ First, we descriptively summarized cancer and genetic testing histories for all patients who received genetic counseling.
Uptake and patient-related outcomes of mainstreaming ...Breast, Unknown, 700, 94.9% (n=374) of participants were satisfied that their questions regarding hereditary breast cancer were answered after genetic testing.
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