Clinical trial NCT04354675: Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed 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

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

Primary outcomes:
measure: Percent of participants who took up genetic testing after not meeting NCCN guidelines for genetic testing
timeFrame: 2 years
measure: Mean overall patient satisfaction with decision about genetic testing: survey
timeFrame: 2 years
measure: Overall comprehension as assessed by BCGCKQ
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of overall cohort with mutation
timeFrame: 2 years
measure: Number of patients who decline genetic testing
timeFrame: 2 years
measure: Frequencies of most common reasons for not pursuing genetic testing
timeFrame: 2 years
measure: Time to treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Zahraa Al-Hilli, MD
role: PRINCIPAL_INVESTIGATOR
References: