Efficacy of Point Of Service Testing in MBC

NCT ID: NCT03983577

Last Updated: 2023-09-25

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2025-08-31

Brief Summary

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This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.

Detailed Description

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Conditions

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Metastatic Cancer Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Point of service delivery model

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.

Group Type EXPERIMENTAL

Point of service delivery model

Intervention Type OTHER

Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.

Interventions

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Point of service delivery model

Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
* Able to speak and read in the English language.
* Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
* Participants must be enrolled in the parent registry study.

Exclusion Criteria

* Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
* Psychiatric illness/social situations that would limit compliance with study requirements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Nye, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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CT Nurse Navigator

Role: CONTACT

913-945-7552

Facility Contacts

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Clinical Trials Nurse Navigator

Role: primary

913-945-7552

Other Identifiers

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ePOST

Identifier Type: -

Identifier Source: org_study_id

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