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

NCT ID: NCT04354675

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Artificial intelligence program

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

Group Type: EXPERIMENTAL

Automated program (ChatBot)

Intervention Type: GENETIC

Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)

BCGCKQ Survey

Intervention Type: OTHER

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Satisfaction Survey

Intervention Type: OTHER

Survey assessing satisfaction with Decision-Genetic Testing

Genetic testing

Intervention Type: DEVICE

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.

in-person genetic counseling

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

Group Type: ACTIVE_COMPARATOR

Genetics counselor

Intervention Type: GENETIC

Traditional in-person genetic counseling

BCGCKQ Survey

Intervention Type: OTHER

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Satisfaction Survey

Intervention Type: OTHER

Survey assessing satisfaction with Decision-Genetic Testing

Genetic testing

Intervention Type: DEVICE

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.

Interventions

Automated program (ChatBot)

Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)

Intervention Type: GENETIC

Genetics counselor

Traditional in-person genetic counseling

Intervention Type: GENETIC

BCGCKQ Survey

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Intervention Type: OTHER

Satisfaction Survey

Survey assessing satisfaction with Decision-Genetic Testing

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zahraa Al-Hilli, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE12119

Identifier Type: -

Identifier Source: org_study_id