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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354675
• Other study ID #: CASE12119
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Automated program (ChatBot)
Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)
• Genetics counselor
Traditional in-person genetic counseling

Other:
• BCGCKQ Survey
Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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