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Genetic Testing for All Breast Cancer Patients (GET FACTS)

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ClinicalTrials.gov Identifier: NCT04245176
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Anna Weiss, MD, Dana-Farber Cancer Institute

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 31, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245176


Contacts
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Contact: Anna Weiss, MD (617) 632-3209 aweiss5@bwh.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anna Weiss, MD    617-632-3209      
Principal Investigator: Anna Weiss, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Myriad Genetics, Inc.
Investigators
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Principal Investigator: Anna Weiss, MD Dana-Farber Cancer Institute
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Responsible Party: Anna Weiss, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04245176    
Other Study ID Numbers: 19-509
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Weiss, MD, Dana-Farber Cancer Institute:
Breast Cancer
Invasive Breast Cancer
in Situ Breast Cancer
Genetic Testing
Quantitative genetic counseling
Standard genetic counseling
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type