Genetic Testing for All Breast Cancer Patients (GET FACTS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed 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.
Investigators
Tari King, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
Time Frame: 1 month
Patient's will be surveyed about their personal propensity to choose a bilateral mastectomy as the surgical treatment of a unilateral cancer before and after quantitative vs. standard counseling. This survey question was self-developed in conjunction with the Dana Farber Cancer Institute professional survey core. The question reads: "How likely or unlikely are you to choose surgery to remove both breasts (bilateral mastectomy) for your cancer in one breast (unilateral or one-sided breast cancer)?"s answer options include the following: "Very unlikely, Somewhat unlikely, Unsure (neither likely nor unlikely), Somewhat likely, Very likely).
Change in patient's assessment of their personal contralateral breast cancer risk
Time Frame: 1 month
A short survey, self-developed in conjunction with the Dana Farber Cancer Institute professional survey core, will be used to compare changes in patients' personal contralateral breast cancer (CBC) risk assessment after quantitative versus standard genetic counseling. The question reads: "By the time you turn 80 years old, what do you believe is the chance you will develop cancer in the other (unaffected) breast?" and answer options are in 10% increments (ie. 0-10%, 11-20%, 21-30%). Their individual assessment of their risk will be collected before and after genetic counseling and will be compared to CBCRisk (for those without gene mutations) or ASK2ME (for those with gene mutations).
Secondary Outcomes
- Contralateral Prophylactic Mastectomy (CPM) Rate(6 Months)
- Genetic Testing Satisfaction(6 Months)
- Level of anxiety among participants, as measured by the PROMIS anxiety scale(6 months)
- Number of participants with decisional regret (testing and surgery choices)(6 months)