Genetic Testing for All Breast Cancer Patients (GET FACTS)

STATUS

Recruiting
participants needed

450
sponsor

Dana-Farber Cancer Institute

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Updated on 19 February 2024

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cancer

breast cancer

breast carcinoma

genetic counseling

cancer diagnosis

genetic testing

Summary

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer

This research study involves an expedited and surgery-specific form of genetic counseling.

The names of the study methods involved in this trial are/is:

Quantitative genetic counseling (discussion is guided by tables and graphs)
Standard genetic counseling

Description

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
- Quantitative genetic counseling: Discussion is guided by tables and graphs.
- Participants will be on the research study for up to six months, with an optional extension to two years.
- It is expected that about 450 people will participate.
- This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
- This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.

Details

Condition	Genetic Testing, Breast Cancer, Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer
Age	18years - 100years
Treatment	Standard Genetic Counseling, Quantitative Genetic Counseling
Clinical Study Identifier	NCT04245176
Sponsor	Dana-Farber Cancer Institute
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing
	Patients with good understanding of written and spoken English
	Patients with apparent cognitive capacity to make surgical decisions for themselves
	Patients who are medically cleared for surgery
	Patients must be at least age 18
Exclusion Criteria
	Previous breast cancer diagnosis (invasive or DCIS)
	Metastatic breast cancer
	Patients who have received prior broad-based panel testing (prior BRCA1/2 testing with negative results allowed)
	Bilateral breast cancer
	Known medical or surgical contraindication to contralateral mastectomy
	Hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers

How to participate?

Step 1 Connect with a study center

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Genetic Testing for All Breast Cancer Patients (GET FACTS)