Genetic Testing for All Breast Cancer Patients (GET FACTS)

Breast Cancer Clinical Trial

Official title:

Genetic Testing for All Breast Cancer Patients (GET FACTS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04245176
• Other study ID #: 19-509
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

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 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma In Situ
• Breast Neoplasms
• Genetic Testing
• in Situ Breast Cancer
• Invasive Breast Cancer

Intervention

Behavioral:
• Standard Genetic Counseling
Standard genetic counseling: Standard of care discussion
• Quantitative Genetic Counseling
Quantitative genetic counseling: Discussion is guided by tables and graphs.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Myriad Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient's assessment of their personal contralateral breast cancer risk	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).	1 month
Primary	Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question	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).	1 month
Secondary	Genetic Testing Satisfaction	Breast cancer patient satisfaction with genetic counseling practices,comparing the delivery of results by quantitative counseling versus standard counseling, as measured by the Genetic Testing Satisfaction Survey (GTS).	6 Months
Secondary	Contralateral Prophylactic Mastectomy (CPM) Rate	CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.	6 Months
Secondary	Level of anxiety among participants, as measured by the PROMIS anxiety scale	Patients' level of anxiety will be compared between quantitative versus standard genetic counseling to monitor that we are avoiding undue stress on the patients. We will use the Patient-Reported Outcomes Information System (PROMIS) anxiety scale. Scores can range from 8-40, with 40 indicating worse anxiety.	6 months
Secondary	Number of participants with decisional regret (testing and surgery choices)	Decisional regret will be measured and compared between quantitative versus standard genetic counseling, for both the decision to undergo genetic testing and the surgical choice that was made.	6 months