Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
NCT ID: NCT04447703
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
346 participants
INTERVENTIONAL
2020-08-27
2024-09-10
Brief Summary
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Detailed Description
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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 (n=10 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 lethal/predicted 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Aim I (Interview)
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.
Interview
Attend Interview
Internet Based Intervention
Use web-based genetic education tool online
Survey Administration
Ancillary Studies
Aim II: Arm I (Genetic Counseling, Genetic Testing)
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.
Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary Studies
Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)
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. Patient may then undergo genetic testing. Patient may cross-over to Arm I to see a genetic counselor.
Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Internet-Based Intervention
Use web-based genetic education tool online
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary Studies
Interventions
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Interview
Attend Interview
Internet Based Intervention
Use web-based genetic education tool online
Survey Administration
Ancillary Studies
Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary Studies
Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Internet-Based Intervention
Use web-based genetic education tool online
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AIM 2: Any English speaking man \>= 18 with PCA who has computer and web-access and meets any one of the following:
* Metastatic disease
* T3a or higher
* Prostate specific antigen (PSA) \> 20
* Grade group 4 or higher
* Intraductal or cribriform histology
* Biochemical recurrence
* Ashkenazi Jewish ancestry
* Family history criteria (see below) \*\* Family history: If any one of the following levels are met, the person is eligible:
* Level 1: \>= 1 close blood relative (first degree relative \[FDR\], second degree relative \[SDR\], third degree relative \[TDR\]) diagnosed with breast cancer =\< age 50 or the following cancers at any age: pancreatic, ovarian, or metastatic or intraductal/cribriform prostate cancer
* Level 2: \>= 2 close blood relatives (FDR, SDR, TDR) on same side of the family with breast or prostate cancer at any age
* Level 3: one brother, father, or \>= 2 family members (close blood relatives - FDR, SDR, TDR) on the same side of the family diagnosed with prostate cancer at \< 60
* Level 4: \>= 3 cancers on the same side of the family (especially if diagnosed =\< 50): bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (grade groups 2-5 if known), small bowel, or urothelial
Exclusion Criteria
* Mental or cognitive impairment that interferes with ability to provide informed consent
* Non-English speaking
* Having had prior germline genetic testing for inherited cancer risk (pertains to aim 2)
18 Years
ALL
Yes
Sponsors
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Prostate Cancer Foundation
OTHER
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Veda Giri, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Cancer Genetics Yale School of Medicine
Stacy Loeb, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
NYU- Langone Health, Manhattan VA Hospital
Locations
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VA New York Harbor Health System- Manhattan Campus
New York, New York, United States
New York University- Langone Health
New York, New York, United States
Associated Medical Professions of New York
Syracuse, New York, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Washington/ SCCA
Seattle, Washington, United States
Countries
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References
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Loeb S, Keith SW, Cheng HH, Leader AE, Gross L, Sanchez Nolasco T, Byrne N, Hartman R, Brown LH, Pieczonka CM, Gomella LG, Kelly WK, Lallas CD, Handley N, Mille PJ, Mark JR, Brown GA, Chopra S, McClellan A, Wise DR, Hollifield L, Giri VN. TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing. JCO Precis Oncol. 2024 Mar;8:e2300552. doi: 10.1200/PO.23.00552.
Loeb S, Cheng HH, Leader A, Gross L, Nolasco TS, Byrne N, Wise DR, Hollifield L, Brown LH, Slater E, Pieczonka C, Gomella LG, Kelly WK, Trabulsi EJ, Handley N, Lallas CD, Chandrasekar T, Mille P, Mann M, Mark JR, Brown G, Chopra S, Wasserman J, Phillips J, Somers P, Giri VN. Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing. Contemp Clin Trials. 2022 Aug;119:106821. doi: 10.1016/j.cct.2022.106821. Epub 2022 Jun 14.
Other Identifiers
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19CHAL05
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
JT 14902
Identifier Type: OTHER
Identifier Source: secondary_id
20G.013
Identifier Type: -
Identifier Source: org_study_id
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