Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

July 1, 2026 updated by: Kevin Sweet, Ohio State University Comprehensive Cancer Center

A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the efficacy of genetic counseling patient preference (GCPP) compared to conventional genetic counseling for adherence to National Comprehensive Cancer Network (NCCN) guidelines for having: 1) a clinical encounter every 6-12 months; and 2) an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended).

II. Determine the efficacy of the GCPP compared to conventional genetic counseling for adherence to other NCCN recommended cancer screening (e.g. colorectal cancer screening).

III. Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling.

EXPLORATORY OBJECTIVE:

I. Explore the genetic counseling preferences among the GCPP group.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive GCPP intervention which uses REDCap and the MyChart patient portal to: 1) deliver a series of educational videos on pre-genetic test information; 2) provide multigene and polygenic risk score (PRS) test results; 3) obtain information about patients' questions/concerns about test results to use in post-genetic test counseling; and 4) determine patient preference (e.g. telehealth) for receipt of post-genetic test counseling.

ARM II: Patients receive conventional genetic counseling with utilization of multigene and polygenic risk score (PRS) test results.

Study Type

Interventional

Enrollment (Actual)

874

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being female.
  • Ages 30-64.
  • Being an Ohio State University (OSU) patient who uses MyChart.
  • Undergoing routine screening mammography.
  • Normal BI-RADS1.
  • At elevated breast cancer risk by the Cancer Risk Assessment (CRA) tool.
  • Able to read and speak English.
  • Provide consent.

Exclusion Criteria:

  • Previous genetic counseling.
  • Previous genetic testing for cancer risk or known mutation in a breast cancer gene: ATM, BARD1, BRCA1, BRCA2, CDH1, CHEK2, NBN, PALB2, PTEN, TP53.
  • Previous diagnosis of breast or ovarian cancer or personal history of lobular carcinoma in situ (LCIS) or breast hyperplasia (with or without atypia).
  • Being a member of a focus group that assisted with the development of the intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (GCPP intervention)
Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.
Other: Survey Administration
Ancillary studies
Other: Educational Intervention
Receive GCPP intervention videos
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Active Comparator: Arm II (conventional genetic counseling)
Patients receive conventional genetic counseling.
Other: Survey Administration
Ancillary studies
Other: Genetic Counseling
Receive genetic counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months
Time Frame: Up to 14 months
Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of genetic counseling patient preference (GCCP) versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.
Up to 14 months
Adherence to NCCN guidelines of having an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended)
Time Frame: Up to 14 months
Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.
Up to 14 months
Risk perception
Time Frame: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Up to 14 months
Breast cancer-specific worry
Time Frame: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Up to 14 months
Post-test/counseling distress
Time Frame: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Up to 14 months
Satisfaction with counseling
Time Frame: Up to 14 months
Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Up to 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)
Time Frame: Up to 14 months
Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.
Up to 14 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic counseling preferences
Time Frame: Up to 14 months
Will estimate the proportion of subjects who choose the remote (versus in-person) mode of the GCCP stratified by detection of high-risk variants, and construct 95% two-sided confidence intervals.
Up to 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kevin Sweet, MS, LGC, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Actual)

March 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-22013
  • R01CA248739 (U.S. NIH Grant/Contract)
  • NCI-2022-01136 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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