Genetic Testing for All Breast Cancer Patients (GET FACTS)

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04245176

Collaborator

Myriad Genetics, Inc. (Industry)

450

Enrollment

Location

Arms

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Invasive Breast Cancer in Situ Breast Cancer Genetic Testing	Behavioral: Standard Genetic Counseling Behavioral: Quantitative Genetic Counseling	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Genetic Testing for All Breast Cancer Patients (GET FACTS)

Actual Study Start Date :

Jan 31, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quantitative Genetic Counseling 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: -- Quantitative genetic counseling: Discussion is guided by tables and graphs.	Behavioral: Quantitative Genetic Counseling Quantitative genetic counseling: Discussion is guided by tables and graphs.
Active Comparator: STANDARD GENETIC COUNSELING 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	Behavioral: Standard Genetic Counseling Standard genetic counseling: Standard of care discussion

Arm

Intervention/Treatment

Experimental: Quantitative Genetic Counseling

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: -- Quantitative genetic counseling: Discussion is guided by tables and graphs.

Behavioral: Quantitative Genetic Counseling

Quantitative genetic counseling: Discussion is guided by tables and graphs.

Active Comparator: STANDARD GENETIC COUNSELING

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

Behavioral: Standard Genetic Counseling

Standard genetic counseling: Standard of care discussion

Outcome Measures

Primary Outcome Measures

Change in patient's assessment of their personal contralateral breast cancer risk [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).
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question [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).

Secondary Outcome Measures

Genetic Testing Satisfaction [6 Months]
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).
Contralateral Prophylactic Mastectomy (CPM) Rate [6 Months]
CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.
Level of anxiety among participants, as measured by the PROMIS anxiety scale [6 months]
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.
Number of participants with decisional regret (testing and surgery choices) [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.