Skip to main content
OpenTrials
Completed

NCT Number: NCT06212310

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Genetic Predisposition Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Knowledge Score

    Time frame: MMIC Survey administered within 7 days prior to and post-genetic counseling visit

    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

  2. Patient Reported Outcome of Patient Satisfaction

    Time frame: GCSS survey administered within 7 days post-genetic counseling visit

    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

  3. Clinical Outcome Measure of Genetic Counseling Visit Completion

    Time frame: Genetic counseling visit completion was evaluated daily, up to 13.5 months

    Measure difference in genetic counseling visit completion rate between study arms

Secondary outcomes

  1. Patient Reported Outcome of Genetic Counseling-specific Empowerment

    Time frame: GOS survey administered within 7 days prior to and post-genetic counseling visit

    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

  2. Number of Participants That Made an Informed Choice

    Time frame: MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment

    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).

  3. Clinical Outcome Measure of Genetic Testing Completion

    Time frame: Sample for testing provided within 45 days of visit without sample failure

    Measure genetic test completion rate between study arms

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Society of Genetic Counselors

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.