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

NCT04354675 | Completed

• 1 other identifier: CASE12119
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Percentage of overall cohort with mutation

  2 years

• Number of patients who decline genetic testing

  2 years

• Frequencies of most common reasons for not pursuing genetic testing

  2 years

• Time to treatment

  3 years

Study Arms (2)

Artificial intelligence program

EXPERIMENTAL

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

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

in-person genetic counseling

ACTIVE COMPARATOR

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

Genetic: Genetics counselor; Other: BCGCKQ Survey; Other: Satisfaction Survey; Device: Genetic testing

Interventions

Automated program (ChatBot) GENETIC

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

Artificial intelligence program

Genetics counselor GENETIC

Traditional in-person genetic counseling

in-person genetic counseling

BCGCKQ Survey OTHER

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Also known as: Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Artificial intelligence program; in-person genetic counseling

Satisfaction Survey OTHER

Survey assessing satisfaction with Decision-Genetic Testing

Artificial intelligence program; in-person genetic counseling

Genetic testing 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.

Artificial intelligence program; in-person genetic counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Zahraa Al-Hilli, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 21, 2020
• Study Start: June 29, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)