Clinical trial NCT05325151: Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-04-13
Enrollment: 874
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months
timeFrame: Up to 14 months
measure: Adherence to NCCN guidelines of having an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended)
timeFrame: Up to 14 months
measure: Risk perception
timeFrame: Up to 14 months
measure: Breast cancer-specific worry
timeFrame: Up to 14 months
measure: Post-test/counseling distress
timeFrame: Up to 14 months
measure: Satisfaction with counseling
timeFrame: Up to 14 months
Secondary outcomes:
measure: Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)
timeFrame: Up to 14 months
Other outcomes:
measure: Genetic counseling preferences
timeFrame: Up to 14 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Kevin Sweet, MS, LGC
role: PRINCIPAL_INVESTIGATOR
References: