NCT06212310

Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

Completed Results posted Last updated 6 December 2024

What this trial tests

trial in Genetic Predisposition in 419 participants. Completed in 31 December 2023.

Timeline

1 February 2022

Primary endpoint
20 March 2023

31 December 2023

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	419
Start date	1 February 2022
Primary completion	20 March 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Conditions studied

• Genetic Predisposition — all drugs for Genetic Predisposition →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 100, any sex, with Genetic Predisposition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Knowledge Score Primary · 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

Group	Value	95% CI
In-person Genetic Counseling	0.05	± 1.37
Telephone Genetic Counseling	-0.08	± 1.51

Patient Reported Outcome of Patient Satisfaction Primary · 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

Group	Value	95% CI
In-person Genetic Counseling	24.64	± 5.38
Telephone Genetic Counseling	25.27	± 3.75

Clinical Outcome Measure of Genetic Counseling Visit Completion Primary · Genetic counseling visit completion was evaluated daily, up to 13.5 months

Measure difference in genetic counseling visit completion rate between study arms

Group	Value	95% CI
In-person Genetic Counseling	141
Telephone Genetic Counseling	131

Patient Reported Outcome of Genetic Counseling-specific Empowerment Secondary · 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

Group	Value	95% CI
In-person Genetic Counseling	-0.21	± 5.34
Telephone Genetic Counseling	0.86	± 4.62

Number of Participants That Made an Informed Choice Secondary · 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).

Group	Value	95% CI
In-person Genetic Counseling	39
Telephone Genetic Counseling	53

Clinical Outcome Measure of Genetic Testing Completion Secondary · Sample for testing provided within 45 days of visit without sample failure

Measure genetic test completion rate between study arms

Group	Value	95% CI
In-person Genetic Counseling	83
Telephone Genetic Counseling	20
In-person Genetic Counseling	0
Telephone Genetic Counseling	3
In-person Genetic Counseling	3
Telephone Genetic Counseling	40
In-person Genetic Counseling	0
Telephone Genetic Counseling	18

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized control trial comparing genetic counseling service delivery models in an underserved population.
   Lahiri S, Mersch J, Zimmerman J, Mauer Hall C, et al · · 2025 · cited 3× · PMID 39370944 · DOI 10.1002/jgc4.1975