Genetic Testing for All Breast Cancer Patients (GET FACTS)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Invasive Breast Cancer; Genetic Testing; in Situ Breast Cancer
• Intervention / Treatment: Behavioral: Quantitative Genetic Counseling; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Contralateral Prophylactic Mastectomy (CPM) Rate	CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.	6 Months
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Myriad Genetics, Inc.
• Investigators: Principal Investigator: Tara King, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 25, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Genetic Testing; Invasive Breast Cancer; in Situ Breast Cancer; Quantitative genetic counseling; Standard genetic counseling
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ
• Other Study ID Numbers: 19-509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No