Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2020-04-23
Brief Title:
Technology-Enhanced Acceleration of Germline Evaluation for Therapy TARGET Study
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Technology-Enhanced Acceleration of Germline Evaluation for Therapy - The TARGET Study
Status:
ACTIVE_NOT_RECRUITING
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 trial performs user testing of a mobile-friendly patient history collection and genetic education tool to improve healthcare providers understanding of prostate cancer genetic testing This trial also compares traditional genetic counseling versus a web-based genetic education WBGE tool to provide information about genetic testing to men with prostate cancer The WBGE tool has educational modules on genetic counseling and testing as well as a patient history collection tool to help providers learn which patients may carry genetic mutations and may be considered for genetic counseling and genetic testing The purpose of this research is to use technology to deliver information on genetic testing for prostate cancer to patients to help them decide whether or not to receive genetic testing
Detailed Description:
PRIMARY OBJECTIVES
I Perform user-testing of an education and patient history collection mobile tool among medical oncologists radiation oncologists and urologists across study practice settings including Veterans Affairs to address genetic referral needs n10 providers Provider-focused II Develop multimedia web-based pretest genetic education WBGE tool and conduct a randomized trial of traditional genetic counseling GC Arm 1 versus vs WBGE Arm 2 for informed and timely uptake of genetic testing for men with lethalpredicted lethal prostate cancer PCA Patient-focused
OUTLINE
AIM I Providers attend an interview over 1 hour to discuss how they would use the tool then receive the tool to test in their clinic for 2 weeks After 2 weeks providers discuss their experience using the tool over 10-15 minutes Providers have the option to use the tool for up to 6 months and complete a brief survey about the benefits and limitations of the tool for patient identification in Arm II
AIM II Patients are randomized to 1 of 2 arms
ARM I TRADITIONAL GENETIC COUNSELING Patients receive genetic counseling with a certified genetic counselor in-person by telehealth or over the phone according to patient preference Patients may then undergo genetic testing
ARM II WEB-BASED GENETIC EDUCATION Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos Patients may then undergo genetic testing Patients may cross-over to Arm I to see a genetic counselor
After the completion of study patients are followed up yearly for up to 5 years
I Perform user-testing of an education and patient history collection mobile tool among medical oncologists radiation oncologists and urologists across study practice settings including Veterans Affairs to address genetic referral needs n10 providers Provider-focused II Develop multimedia web-based pretest genetic education WBGE tool and conduct a randomized trial of traditional genetic counseling GC Arm 1 versus vs WBGE Arm 2 for informed and timely uptake of genetic testing for men with lethalpredicted lethal prostate cancer PCA Patient-focused
OUTLINE
AIM I Providers attend an interview over 1 hour to discuss how they would use the tool then receive the tool to test in their clinic for 2 weeks After 2 weeks providers discuss their experience using the tool over 10-15 minutes Providers have the option to use the tool for up to 6 months and complete a brief survey about the benefits and limitations of the tool for patient identification in Arm II
AIM II Patients are randomized to 1 of 2 arms
ARM I TRADITIONAL GENETIC COUNSELING Patients receive genetic counseling with a certified genetic counselor in-person by telehealth or over the phone according to patient preference Patients may then undergo genetic testing
ARM II WEB-BASED GENETIC EDUCATION Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos Patients may then undergo genetic testing Patients may cross-over to Arm I to see a genetic counselor
After the completion of study patients are followed up yearly for up to 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19CHAL05 | OTHER_GRANT | Prostate Cancer Foundation | None |