Overview
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.
Eligibility
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.