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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

874 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer

NCT05158452

Breast Carcinoma

COMPLETED

Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

NCT00165152

Breast Cancer Ovarian Cancer

COMPLETED NA

Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling

NCT03225170

Breast Cancer

COMPLETED NA

Genetic Education in BRCA Families

NCT03544983

BRCA1 Mutation BRCA2 Mutation

ENROLLING_BY_INVITATION NA

Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions

NCT00262899

Breast Cancer Psychosocial Effects of Cancer and Its Treatment

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (GCPP intervention)

Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive GCPP intervention videos

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (conventional genetic counseling)

Patients receive conventional genetic counseling.

Group Type ACTIVE_COMPARATOR

Genetic Counseling

Intervention Type OTHER

Receive genetic counseling

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational Intervention

Receive GCPP intervention videos

Intervention Type OTHER

Genetic Counseling

Receive genetic counseling

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes