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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Genetic: Automated program (ChatBot); Other: BCGCKQ Survey; Other: Satisfaction Survey; Device: Genetic testing; Genetic: Genetics counselor

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahraa Al-Hilli, MD; Phone Number: 1-866-223-8100; Email: TaussigResearch@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
      • Contact: Zahraa Al-Hilli, MD; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artificial intelligence program; Will complete consult with the use of an artificial intelligence program Chatbot.	Genetic: Automated program (ChatBot); Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot); Other: BCGCKQ Survey; Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ); Other Names: 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.
Active Comparator: in-person genetic counseling; Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor	Other: BCGCKQ Survey; Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ); Other Names: 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.; Genetic: Genetics counselor; Traditional in-person genetic counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing	Up-take of testing for those who do not meet NCCN guidelines for genetic testing	2 years
Mean overall patient satisfaction with decision about genetic testing: survey	Mean overall patient satisfaction with decision about genetic testing as assessed by survey. The survey is a previously validated six-question Likert scale based survey. The scale ranges from 6 to 30, with higher scores indicating more satisfaction. Satisfaction will be compared between groups with t-test or Wilcoxon rank sum test. Published data suggest that standard deviation on the satisfaction survey is 3. A 2 point difference in average satisfaction score between groups is considered to be relevant	2 years
Overall comprehension as assessed by BCGCKQ	Comprehension as assessed by previously validated survey consisting of 27 questions, which are a blend of True or False and multiple choice questions. The scale ranges from to , with higher scores indicating more comprehension. Comprehension will be compared between groups with t-test or Wilcoxon rank sum test.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of overall cohort with mutation	Mutation rate as described by percentage of overall cohort with mutation. Groups will be compared with Chi-square test or Fisher's exact test	2 years
Number of patients who decline genetic testing	Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test	2 years
Frequencies of most common reasons for not pursuing genetic testing	Reasons for not pursuing genetic testing in those who declined will be collected as a descriptive measure and then analyzed as frequencies of the different responses, summarizing the most common answers	2 years
Time to treatment	Time to treatment will be compared between patients who had genetic testing to those who did not using t-test or Wilcoxon rank sum test among all study patients.	3 years

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Zahraa Al-Hilli, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE12119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Commercially available software being used to conduct the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes