Clinical trial NCT06212310: Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Official title: Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition
Keywords: genetic counseling service delivery
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Society of Genetic Counselors
First posted: 2024-01-18
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals referred to genetic counseling as part of standard of care

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knowledge Score
timeFrame: MMIC Survey administered within 7 days prior to and post-genetic counseling visit
measure: Patient Reported Outcome of Patient Satisfaction
timeFrame: GCSS survey administered within 7 days post-genetic counseling visit
measure: Clinical Outcome Measure of Genetic Counseling Visit Completion
timeFrame: Genetic counseling visit completion was evaluated daily, up to 13.5 months
Secondary outcomes:
measure: Patient Reported Outcome of Genetic Counseling-specific Empowerment
timeFrame: GOS survey administered within 7 days prior to and post-genetic counseling visit
measure: Number of Participants That Made an Informed Choice
timeFrame: MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment
measure: Clinical Outcome Measure of Genetic Testing Completion
timeFrame: Sample for testing provided within 45 days of visit without sample failure
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Sara Pirzadeh-Miller, M.S.
role: PRINCIPAL_INVESTIGATOR
References: