Back to resultsGenetic Testing for All Breast Cancer Patients (GET FACTS)
Primary Purpose
Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Genetic Counseling
Quantitative Genetic Counseling
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Genetic Testing, Quantitative genetic counseling, Standard genetic counseling
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.
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quantitative Genetic Counseling
STANDARD GENETIC COUNSELING
Arm 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: -- Quantitative genetic counseling: Discussion is guided by tables and graphs.
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
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
Contralateral Prophylactic Mastectomy (CPM) Rate
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
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)
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.
Full Information
NCT ID
NCT04245176
First Posted
January 17, 2020
Last Updated
February 14, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Myriad Genetics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04245176
Brief Title
Genetic Testing for All Breast Cancer Patients (GET FACTS)
Official Title
Genetic Testing for All Breast Cancer Patients (GET FACTS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Myriad Genetics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Genetic Testing
Keywords
Breast Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Genetic Testing, Quantitative genetic counseling, Standard genetic counseling
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantitative Genetic Counseling
Arm Type
Experimental
Arm 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:
-- Quantitative genetic counseling: Discussion is guided by tables and graphs.
Arm Title
STANDARD GENETIC COUNSELING
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Standard Genetic Counseling
Intervention Description
Standard genetic counseling: Standard of care discussion
Intervention Type
Behavioral
Intervention Name(s)
Quantitative Genetic Counseling
Intervention Description
Quantitative genetic counseling: Discussion is guided by tables and graphs.
Primary Outcome Measure Information:
Title
Change in patient's assessment of their personal contralateral breast cancer risk
Description
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).
Time Frame
1 month
Title
Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Genetic Testing Satisfaction
Description
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).
Time Frame
6 Months
Title
Contralateral Prophylactic Mastectomy (CPM) Rate
Description
CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.
Time Frame
6 Months
Title
Level of anxiety among participants, as measured by the PROMIS anxiety scale
Description
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.
Time Frame
6 months
Title
Number of participants with decisional regret (testing and surgery choices)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara King, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Genetic Testing for All Breast Cancer Patients (GET FACTS)
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