Clinical trial NCT04245176: Genetic Testing for All Breast Cancer Patients (GET FACTS)
Official title: Genetic Testing for All Breast Cancer Patients (GET FACTS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Myriad Genetics, Inc.
First posted: 2020-01-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in patient's assessment of their personal contralateral breast cancer risk
timeFrame: 1 month
measure: Change in patient's propensity to choose bilateral mastectomy as determined by a short self-developed survey question
timeFrame: 1 month
Secondary outcomes:
measure: Genetic Testing Satisfaction
timeFrame: 6 Months
measure: Contralateral Prophylactic Mastectomy (CPM) Rate
timeFrame: 6 Months
measure: Level of anxiety among participants, as measured by the PROMIS anxiety scale
timeFrame: 6 months
measure: Number of participants with decisional regret (testing and surgery choices)
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Tara King, MD
role: PRINCIPAL_INVESTIGATOR
References: