N/A
N=419
Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Genetic Predisposition
Bottom Line
View on ClinicalTrials.gov: NCT06212310 ↗Enrolled (actual)
419
Serious AEs
—
Results posted
Dec 2024
Primary outcome: Primary: Change in Knowledge Score — 0.05; -0.08 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Knowledge Score |
0.05; -0.08 | — |
| PRIMARY Patient Reported Outcome of Patient Satisfaction |
24.64; 25.27 | — |
| PRIMARY Clinical Outcome Measure of Genetic Counseling Visit Completion |
141; 131 | — |
| SECONDARY Patient Reported Outcome of Genetic Counseling-specific Empowerment |
-0.21; 0.86 | — |
| SECONDARY Number of Participants That Made an Informed Choice |
39; 53 | — |
| SECONDARY Clinical Outcome Measure of Genetic Testing Completion |
83; 20; 0; 3; 3; 40 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06212310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.