Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Satisfaction Survey; Other: BCGCKQ Survey; Device: Genetic testing; Genetic: Genetics counselor; Genetic: Automated program (ChatBot)

Study type: Interventional

Funder types: Other

Identifiers

NCT04354675

CASE12119

Details and patient eligibility

About

The purpose of this study is to help better understand the uptake and impact of genetic testing for women diagnosed with breast cancer who do not meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing. By doing so, the research team will gain a better understanding of the clinical implications for offering genetic testing for all patients recently diagnosed with breast cancer versus only offering genetic testing to those meeting NCCN criteria.

By offering genetic counseling and genetic testing to all women recently diagnosed with breast cancer, there will be a shortage of genetic counselors. This study will also assess the feasibility of using artificial intelligence to assist in the genetic counseling process.

Full description

This is a randomized trial comparing the effectiveness of pre-test genetic counseling using an artificial intelligence program and traditional in-person genetic counseling in women newly diagnosed with breast cancer who do not currently meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing.

The primary objectives of this study are:

1. To determine up-take of testing for those who do not meet NCCN guidelines for genetic testing
2. To assess overall patient satisfaction and comprehension in both groups

The secondary objectives of this study are:

1. To assess mutation rate in the overall cohort
2. Identify reasons for not pursuing genetic testing
3. Identify any specific areas of improvement in satisfaction and comprehension
4. Assess the impact of genetic testing on Time to Treatment in this cohort
5. Develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects diagnosed with Stage 0-3 breast cancer.
• Patients who do not satisfy current NCCN criteria for referral to a genetics counselor and genetics testing.
• Must have the ability to understand and the willingness to sign a written informed consent document as well as complete the study questionnaires.

Exclusion criteria

• N/A

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Artificial intelligence program

Experimental group

Description:

Will complete consult with the use of an artificial intelligence program Chatbot.

Treatment:

Genetic: Automated program (ChatBot)

Device: Genetic testing

Other: BCGCKQ Survey

Other: Satisfaction Survey

in-person genetic counseling

Active Comparator group

Description:

Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor

Treatment:

Genetic: Genetics counselor

Device: Genetic testing

Other: BCGCKQ Survey

Other: Satisfaction Survey