Breast Cancer Clinical Trial

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

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.

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Full 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:

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

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

35

Study ID:

NCT04354675

Recruitment Status:

Active, not recruiting

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

35

Study ID:

NCT04354675

Recruitment Status:

Active, not recruiting

Sponsor:


Case Comprehensive Cancer Center

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