Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-06 @ 7:16 AM
Study NCT ID:
NCT05325151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-01136 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| R01CA248739 | NIH | None | https://reporter.nih.gov/quic… | View |