Efficacy of Point Of Service Testing in MBC

University of Kansas Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Metastatic Cancer Breast Cancer

Interventions

Point of service delivery modelOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

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.

Time frame: 24 months

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.

Time frame: 24 months

Central Contacts

CT Nurse Navigator

CONTACT

913-945-7552 ctnursenav@kumc.edu

Data from ClinicalTrials.gov

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