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Genetic Counseling Delivery Model for Metastatic Breast Cancer (EPOST MBC Trial)

N/A

Recruiting

Led By Lauren Nye, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

EPOST MBC Trial Summary

This trial will test a new way of delivering cancer genetic counseling to people with metastatic breast cancer who have been referred for such counseling and testing.

Who is the study for?

This trial is for individuals or their legal representatives who understand the study and consent to participate, speak English, have HER2-negative metastatic breast cancer, and are enrolled in the parent registry study. It excludes those with psychiatric conditions affecting compliance or who've had certain genetic tests after 2013.Check my eligibility

What is being tested?

The trial is evaluating a new point of service delivery model for cancer genetics counseling in patients with metastatic breast cancer. The focus is on its effectiveness when patients receive referrals for hereditary cancer genetic counseling and testing.See study design

What are the potential side effects?

Since this trial involves a service delivery model rather than a drug intervention, traditional side effects are not applicable. However, there may be psychological impacts from receiving genetic counseling which will be monitored.

EPOST MBC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My breast cancer is metastatic and HER2 negative.

EPOST MBC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.

Secondary outcome measures

Clinical decisional conflict score

Overall participant anxiety

Overall participant satisfaction

EPOST MBC Trial Design

1Treatment groups

Experimental Treatment

Group I: Point of service delivery modelExperimental Treatment1 Intervention

After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,170 Total Patients Enrolled

22 Trials studying Breast Cancer

4,410 Patients Enrolled for Breast Cancer

Lauren Nye, MDPrincipal InvestigatorUniversity of Kansas

2 Previous Clinical Trials

14 Total Patients Enrolled

1 Trials studying Breast Cancer

11 Patients Enrolled for Breast Cancer

Media Library

Point of Service Delivery Model (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03983577 — N/A

Breast Cancer Research Study Groups: Point of service delivery model

Breast Cancer Clinical Trial 2023: Point of Service Delivery Model Highlights & Side Effects. Trial Name: NCT03983577 — N/A

Point of Service Delivery Model (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983577 — N/A

Frequently Asked Questions

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

How many participants have been recruited for this experiment?

"Affirmative. According to information listed on clinicaltrials.gov, the study has been recruiting since June 11th 2019 and remains open for enrollment as of September 19th 2022. One site is looking for 100 participants in total."

Answered by AI

Is there still an opportunity for individuals to join this experiment?

"Affirmative. Clinicaltrials.gov states that this trial, which first opened enrollment on June 11th 2019, is currently recruiting patients to the study. A total of 100 individuals are needed from 1 site in order to complete this medical experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Point Of Service Testing in MBC

2019. "Efficacy of Point Of Service Testing in MBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03983577.

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