Recruiting

Genetic Counseling

Sponsor:

University of Kansas Medical Center

Code:

NCT03983577

Conditions

Metastatic Cancer

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Point of service delivery model

Study Details

Brief summary:

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.

Conditions

Metastatic Cancer

Breast Cancer

Study ID

NCT03983577

Start date

Jun 11, 2019

Status verified date

Sep, 2023

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

CT Nurse Navigator

913-945-7552ctnursenav@kumc.edu

Locations

The University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Sep 25, 2023

Last verified

Sep, 2023

Keywords

  • genetic counseling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2023-09-25.