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Completed

NCT Number: NCT04354675

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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:

  • To determine up-take of testing for those who do not meet NCCN guidelines for genetic testing
  • To assess overall patient satisfaction and comprehension in both groups

The secondary objectives of this study are:

  • To assess mutation rate in the overall cohort
  • Identify reasons for not pursuing genetic testing
  • Identify any specific areas of improvement in satisfaction and comprehension
  • Assess the impact of genetic testing on Time to Treatment in this cohort
  • Develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated program (ChatBot)

Genetic

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

Genetics counselor

Genetic

Traditional in-person genetic counseling

BCGCKQ Survey

Other

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

Other names: Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

satisfaction survey

Other

Survey assessing satisfaction with Decision-Genetic Testing

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.

Primary outcomes

  1. Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing

    Time frame: 2 years

    Up-take of testing for those who do not meet NCCN guidelines for genetic testing

  2. Mean overall patient satisfaction with decision about genetic testing: survey

    Time frame: 2 years

    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

  3. Overall comprehension as assessed by BCGCKQ

    Time frame: 3 years

    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.

Secondary outcomes

  1. Percentage of overall cohort with mutation

    Time frame: 2 years

    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. Number of patients who decline genetic testing

    Time frame: 2 years

    Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test

  3. Frequencies of most common reasons for not pursuing genetic testing

    Time frame: 2 years

    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

  4. Time to treatment

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2020
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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