Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

NCT06212310 | Completed Results DMC

• 1 other identifier: 2021-1008
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic Predisposition

Keywords

genetic counseling service delivery

Outcome Measures

Primary Outcomes (3)

• Change in Knowledge Score

  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

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

• Patient Reported Outcome of Patient Satisfaction

  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

  GCSS survey administered within 7 days post-genetic counseling visit

• Clinical Outcome Measure of Genetic Counseling Visit Completion

  Measure difference in genetic counseling visit completion rate between study arms

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

Secondary Outcomes (3)

• Patient Reported Outcome of Genetic Counseling-specific Empowerment

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

• 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

• Clinical Outcome Measure of Genetic Testing Completion

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

Study Arms (2)

In-person genetic counseling

Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.

Telephone genetic counseling

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals referred to genetic counseling as part of standard of care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Society of Genetic Counselors: collaborator

Study Sites (1)

Parkland Health

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Use of non-validated instruments (Multi-dimensional Model of Informed Choice and Genomics Outcome Scale), higher drop-off rate of enrolled study participants (50% observed; 30% anticipated

Results Point of Contact

• Title: Sayoni Lahiri
• Organization: UT Southwestern Medical Center

sayoni.lahiri@utsouthwestern.edu

214-645-2563

Study Officials

• Sara Pirzadeh-Miller, M.S.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Cancer Genetics Program

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 1, 2022
• Primary Completion: March 20, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)