Breast Cancer Clinical Trial
Genetic Testing for All Breast Cancer Patients (GET FACTS)
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
Full 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.
Eligibility Criteria
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 but under 79
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.
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There is 1 Location for this study
Boston Massachusetts, 02115, United States
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