NCT04354675

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	Automated program (ChatBot)	Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)
GENETIC	Genetics counselor	Traditional in-person genetic counseling
OTHER	BCGCKQ Survey	Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
OTHER	Satisfaction Survey	Survey assessing satisfaction with Decision-Genetic Testing
DEVICE	Genetic testing	Genetic testing for all participants will assess for a mutation in 47 genes commonly associated with hereditary cancer syndromes (Invitae's Common Hereditary Cancer Panel) for those who choose to complete testing.

Timeline

• Start date: 2021-06-29
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2020-04-21
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States