Efficacy of Point Of Service Testing in MBC

Breast Cancer Clinical Trial

— EPOST MBC  

Official title:

Efficacy of Point Of Service Testing in Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983577
• Other study ID #: ePOST
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: University of Kansas Medical Center
• Contact: CT Nurse Navigator
• Phone: 913-945-7552
• Email: ctnursenav[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.	Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.	24 months
Secondary	Overall participant satisfaction	Patient satisfaction will be assessed with an adapted Genetic Counseling Satisfaction Scale (aGCSS). Each item is scored from 1- 5, with 1 being strongly disagree and 5 being agree strongly. The scores are added then divided by 5 to give a mean score.	24 months
Secondary	Clinical decisional conflict score	Decisional conflict will be assessed using the Decisional Conflict Scale (Sure Test Version). The 4 items are summed. Scores range from 0 (extremely high decisional conflict) to 4 (no decisional conflict). A score of less than or equal to 3 indicates decisional conflict.	24 months
Secondary	Overall participant anxiety	Participant anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS-Anxiety scale). Each item is scored between 0- 3 with a total score between 0- 21 possible. Scores of 0-7 indicates normal; scores of 8-10 indicates borderline abnormal; scores of 11-21 indicates abnormal.	24 months