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. Our 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. We 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. We 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: Interventional
• Enrollment (Actual): 201
• 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

Description

Inclusion Criteria:

• Patients who are English or Spanish-speaking adults (18 years and older) already scheduled for cancer genetic counseling. Participants must either be uninsured or have Medicaid, and they must not have previously had germline genetic testing or cancer genetic counseling. Participants must have a working telephone number and valid e-mail address. Internet access is a requirement to complete electronic study surveys, receive study-related documents electronically.

Exclusion Criteria:

• Patients referred for surgical planning pending genetic test results. Minors (under age 18 years). Pregnant women. Decisionally impaired. Students/ residents. Patients who do not speak English or Spanish. Prisoners. Individuals without working telephone number and valid e-mail address or internet access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: In-person genetic counseling; Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.
Active Comparator: Telephone genetic counseling; Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service.	Other: Telephone genetic counseling; genetic counseling service delivered audio-only; Other Names: service delivery type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome	Service satisfaction	Survey administered within 7 days of visit
Patient reported outcome	Genetic knowledge	Survey administered within 7 days of visit
Clinical outcome	Genetic counseling visit completion rate	Completion of visit on scheduled date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome	Informed choice for genetic testing	Survey administered within 7 days of visit
Clinical outcome	Genetic testing completion rate	Testing must be complete within 90 days of visit
Clinical outcome	Genetic test sample failure/cancelation rate	Within 90 days of visit

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 (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 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