Genetic Testing for All Breast Cancer Patients (GET FACTS)

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Breast Cancer; In Situ Breast Cancer; Genetic Testing; Invasive Breast Cancer

Treatments: Behavioral: Standard Genetic Counseling; Behavioral: Quantitative Genetic Counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04245176

19-509

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Quantitative Genetic Counseling

Experimental group

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.

Treatment:

Behavioral: Quantitative Genetic Counseling

STANDARD GENETIC COUNSELING

Active Comparator group

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

Treatment:

Behavioral: Standard Genetic Counseling