Genetic Testing for All Breast Cancer Patients (GET FACTS)

• ClinicalTrials.gov Identifier: NCT04245176
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2020
• Last Update Posted: January 5, 2024
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Myriad Genetics, Inc.
• Information provided by (Responsible Party): Tari King, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: January 17, 2020
• First Posted Date: January 28, 2020
• Last Update Posted Date: January 5, 2024
• Actual Study Start Date: January 31, 2020
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 25, 2020)

• 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).
• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2020)

• Genetic Testing Satisfaction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genetic Testing for All Breast Cancer Patients (GET FACTS)
• Official Title: Genetic Testing for All Breast Cancer Patients (GET FACTS)

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Breast Cancer
• Invasive Breast Cancer
• in Situ Breast Cancer
• Genetic Testing

Intervention

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

Study Arms

• 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.

  Intervention: Behavioral: Quantitative Genetic Counseling
• 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

  Intervention: Behavioral: Standard Genetic Counseling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 14, 2023): 400
• Original Estimated Enrollment (submitted: January 25, 2020): 450
• Estimated Study Completion Date: December 1, 2024
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04245176
• Other Study ID Numbers: 19-509
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

• Current Responsible Party: Tari King, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Anna Weiss, MD, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Myriad Genetics, Inc.

Investigators

• Principal Investigator: Tara King, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: January 2024