Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

Not Applicable

Completed

Conditions: Genetic Predisposition

Interventions: Other: Telephone genetic counseling

Registration Number: NCT06212310

Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 419

Inclusion Criteria

Not provided

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telephone genetic counseling	Telephone genetic counseling	Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service.

Primary Outcome Measures

Name	Time	Method
Change in Knowledge Score	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
Patient Reported Outcome of Patient Satisfaction	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
Clinical Outcome Measure of Genetic Counseling Visit Completion	Genetic counseling visit completion was evaluated daily, up to 13.5 months	Measure difference in genetic counseling visit completion rate between study arms

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome of Genetic Counseling-specific Empowerment	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
Number of Participants That Made an Informed Choice	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).
Clinical Outcome Measure of Genetic Testing Completion	Sample for testing provided within 45 days of visit without sample failure	Measure genetic test completion rate between study arms