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Genetic Counseling for Breast Cancer

N/A

Recruiting

Led By Kevin Sweet, MS, LGC

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 30-64

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

Study Summary

This trial is testing whether a genetic counseling patient preference (GCPP) intervention delivered via the EHR MyChart patient portal is non-inferior to conventional genetic counseling in terms of several outcomes, including adherence to screening recommendations, breast cancer knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling.

Who is the study for?

This trial is for women aged 30-64 who are patients at Ohio State University, use the MyChart portal, and are undergoing routine mammography. They must be at elevated risk for breast cancer as determined by a specific tool but cannot have had previous genetic counseling or testing for cancer risk genes, nor a personal history of certain breast conditions or cancers.Check my eligibility

What is being tested?

The study compares a new Genetic Counseling Patient Preference (GCPP) intervention delivered through an electronic health record portal to traditional in-person genetic counseling. It aims to see if GCPP can match conventional methods in terms of adherence to screening recommendations and patient satisfaction without increasing worry.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medications, typical drug side effects aren't expected. However, participants may experience psychological impacts such as increased anxiety or stress related to learning about their genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 30 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breast

Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months

Breast cancer-specific worry

+3 more

Secondary outcome measures

Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)

Other outcome measures

Genetic counseling preferences

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (GCPP intervention)Experimental Treatment2 Interventions

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

Group II: Arm II (conventional genetic counseling)Active Control2 Interventions

Patients receive conventional genetic counseling.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,923,368 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

289,167 Total Patients Enrolled

22 Trials studying Breast Cancer

2,884 Patients Enrolled for Breast Cancer

Kevin Sweet, MS, LGCPrincipal InvestigatorOhio State University Comprehensive Cancer Center

1 Previous Clinical Trials

8 Total Patients Enrolled

Media Library

Conventional Genetic Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05325151 — N/A

Breast Cancer Research Study Groups: Arm I (GCPP intervention), Arm II (conventional genetic counseling)

Breast Cancer Clinical Trial 2023: Conventional Genetic Counseling Highlights & Side Effects. Trial Name: NCT05325151 — N/A

Conventional Genetic Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05325151 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to join this investigation?

"For this clinical trial, 1000 female patients between the ages of 30 and 64 with breast carcinoma are sought. The primary requirements for enrolment include being an Ohio State University patient registered on MyChart, having undertaken routine mammography screening , possessing a normal BI-RADS1 rating, exhibiting elevated cancer risk through CRA assessment tooling, understanding English language fluency and granting consent."

Answered by AI

Is the recruitment process for this trial still ongoing?

"Indeed, clinicaltrials.gov lists the trial as currently enrolling participants. It was initially posted on June 13th 2022 and last amended on November 3rd of that same year."

Answered by AI

Does this trial cater to those who are of advanced age?

"The upper limit for patient eligibility is 64 years old, while the lower bound stands at 30."

Answered by AI

What is the enrollment capacity for this clinical experiment?

"Affirmative. Clinicaltrials.gov data shows this clinical trial was introduced on June 13th 2022 and is currently looking for 1000 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kevin Sweet 2022. "Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05325151.