Efficacy of Point Of Service Testing in MBC

Not Applicable

Recruiting

• Conditions: Metastatic Cancer; Breast Cancer
• Interventions: Other: Point of service delivery model

• Registration Number: NCT03983577
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study Start: 2019-06-11
• Study First Posted: 2019-06-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Point of service delivery model	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.	24 months	Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.

Secondary Outcome Measures

Name	Time	Method
Clinical decisional conflict score	24 months	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.
Overall participant satisfaction	24 months	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.
Overall participant anxiety	24 months	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.

Trial Locations

Locations (1)

The University of Kansas Cancer Center, Westwood Campus; 🇺🇸 Kansas City, Kansas, United States