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

NCT04354675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Zahraa Al-Hilli, MD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04354675 on ClinicalTrials.gov