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| Name | Class |
|---|---|
| Myriad Genetics, Inc. | INDUSTRY |
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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantitative Genetic Counseling | Experimental | 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. |
|
| STANDARD GENETIC COUNSELING | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Genetic Counseling | Behavioral | Standard genetic counseling: Standard of care discussion |
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| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tara King, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41525075 | Derived | Weiss A, Braun D, Stopfer J, Zhao J, McGrath M, Bradshaw KR, Rosito MS, Davis D, Garber JE, King TA. Genetic Testing for All Breast Cancer Patients: The GET FACTS Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551553. doi: 10.1001/jamanetworkopen.2025.51553. |
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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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Quantitative Genetic Counseling | Behavioral | Quantitative genetic counseling: Discussion is guided by tables and graphs. |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |