Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06212310
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2024-01-08
Brief Title:
Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
The main questions 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 Our 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 cancelationfailure rate We 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 We 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None