Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

This 2-arm prospective, randomized, controlled clinical trial compared outcomes of telephone genetic counseling (intervention) versus in-person genetic counseling (control) in an underserved, multilingual patient population referred for cancer genetic counseling at two North Texas safety-net hospitals.

The main question[s] it aims to answer are:

• Is telephone genetic counseling equal to in-person genetic counseling in the patient reported outcomes? Cancer genetics knowledge, attitude towards GT, and informed choice as well as GC-specific empowerment.
• Is telephone genetic counseling-based clinical outcomes the same as in-person genetic counseling for visit completion and testing rates? Participants will be randomized to either in-person or telephone genetic counseling arm and complete standard of care genetic counseling visit process where testing is offered. Both arms will complete a series of surveys to assess the outcomes of interest.

Study Overview

• Status: Completed
• Conditions: Genetic Predisposition
• Intervention / Treatment: Other: Telephone genetic counseling

Detailed Description

The overarching goal of this pilot prospective randomized controlled study is to compare patient-reported and clinical operations outcomes between in-person genetic counseling (IPGC - control) and telephone-based genetic counseling (TGC - intervention) in an indigent English or Spanish-speaking population seeking genetic counseling for hereditary cancer syndromes to create a framework for effective and efficient genetic service delivery in these populations nationally. General genetic education and principles will be conveyed through a standard genetic counseling session including a pre-test education video in both the TGC and IPGC arms. The primary project objectives are to compare the following outcomes between the IPGC and TGC study arms. Aim 1: Patient reported outcomes - A. Patient satisfaction with genetic counseling visit; B. Knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives. Secondary objectives for this aim are: 1. Patient ability to make informed choice; and 2. Genetic counseling-specific empowerment outcomes. Aim 2: Clinical outcomes - visit completion rate; Secondary objectives are: 1. Genetic testing completion rate; and 2. Genetic testing cancelation/failure rate. Investigators hypothesize that patients in the TGC arm will not have significant differences in knowledge, satisfaction, informed choice or genetic counseling-specific empowerment compared to the IPGC arm. Investigators also expect significantly increased visit completion rate and lower test completion rate in the TGC arm compared to the IPGC arm, but no significant difference in sample failure rate.

• Study Type: Observational
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Parkland Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals referred to genetic counseling as part of standard of care

Description

Inclusion Criteria:

Exclusion Criteria:

• Patients who are English or Spanish-speaking
• Adults (18 years and older)
• Patients scheduled for cancer genetic counseling
• Patients must either be uninsured or have Medicaid
• Patients must have no prior germline genetic testing or cancer genetic counseling
• Patients must have a working telephone number and valid e-mail address
• Patients must have Internet access to complete electronic study surveys, and receive study-related documents electronically

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
In-person genetic counseling; Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.
Telephone genetic counseling; Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knowledge Score	Measure change in knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives pre- and post- genetic counseling using the Multi-dimensional Model of Informed Choice (MMIC) scale knowledge score, with minimum and maximum scores of 0 and 8 respectively, and higher scores correlated with better knowledge	MMIC Survey administered within 7 days prior to and post-genetic counseling visit
Patient Reported Outcome of Patient Satisfaction	Measure patient-reported patient satisfaction with genetic counseling visit using the Genetic Counseling Satisfaction Scale (GCSS) scores, with minimum and maximum values of 6 and 30 respectively and higher scores correlated with higher satisfaction	GCSS survey administered within 7 days post-genetic counseling visit
Clinical Outcome Measure of Genetic Counseling Visit Completion	Measure difference in genetic counseling visit completion rate between study arms	Genetic counseling visit completion was evaluated daily, up to 13.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome of Genetic Counseling-specific Empowerment	Measure change in patient reported genetic counseling-specific empowerment pre and post-genetic counseling using the Genomic Outcome Scale (GOS) scores with minimum and maximum scores of 6 and 30 respectively and higher scores correlated with improved outcomes	GOS survey administered within 7 days prior to and post-genetic counseling visit
Number of Participants That Made an Informed Choice	Participants' ability to make an informed choice is assessed by the number of participants that made an informed choice using the Multi-dimensional Model of Informed Choice composite tool that includes understanding of relevant knowledge (1-8 items-higher scores indicate greater knowledge), attitudes toward testing (1-5 items-higher scores represent more positive attitudes), and whether the test decision is congruent with personal values (positive or negative about testing in relation to whether testing was accepted or declined).	MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment
Clinical Outcome Measure of Genetic Testing Completion	Measure genetic test completion rate between study arms	Sample for testing provided within 45 days of visit without sample failure

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Society of Genetic Counselors
• Investigators: Principal Investigator: Sara Pirzadeh-Miller, M.S., UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: genetic counseling service delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 2021-1008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No