Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study

NCT04447703 | Completed DMC

• 3 other identifiers: 20G.01319CHAL05JT 14902
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 5

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.

Conditions

Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• User Testing of the Provider Tool - (Aim I)

  Provider perspectives will include: (1) whether the target population can use the tool in the way it was intended (i.e., to perform patient history collection to determine consideration for germline testing), and (2) interaction with this tool affects the user's cognitive representation of genetic testing for prostate cancer (PCA). To evaluate the first point, will collect initial information from participants regarding their experience with the guidelines for genetic testing and how they collect data on family history. Will evaluate participants' mental model for germline testing and how they identify suitable candidates before interaction with the tool. Will use a cognitive concept mapping technique, which can be used to formalize a person's cognitive representation for complex topics. Feedback from this testing will be used to iteratively refine the tool while it is being used by providers to identify patients randomized trial in Aim II.

  Up to 6 months

• Decisional Conflict (Aim II)

  Will be assessed for non-inferiority between study arms. Evaluated using the O'Connor decisional conflict scale, which captures sub-scores over 16-questions for uncertainty, feeling of being informed, values clarity, support, and effective decision making on a 5-point Likert scale

  Up to 6 months

Secondary Outcomes (3)

• Cancer Genetics Knowledge (Aim II)

  Up to 6 Months

• Genetic Testing Uptake (Aim II)

  Up to 5 years

• Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)

  After viewing the web tool

Other Outcomes (6)

• Understanding of personal genetic test results (Aim II)

  Up to 5 years

• Sharing of genetic information with families (Aim II)

  Up to 5 years

• Literacy (Aim II)

  Up to 5 years

Study Arms (3)

Aim I (Interview)

EXPERIMENTAL

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.

Other: Interview; Other: Internet Based Intervention; Other: Survey Administration

Aim II: Arm I (Genetic Counseling, Genetic Testing)

ACTIVE COMPARATOR

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.

Other: Genetic Counseling; Genetic: Genetic Testing; Other: Survey Administration

Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)

EXPERIMENTAL

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.

Other: Genetic Counseling; Other: Internet-Based Intervention; Genetic: Genetic Testing; Other: Survey Administration

Interventions

Interview OTHER

Attend Interview

Aim I (Interview)

Internet Based Intervention OTHER

Use web-based genetic education tool online

Aim I (Interview)

Survey Administration OTHER

Ancillary Studies

Aim I (Interview)

Genetic Counseling OTHER

Receive in-person, telehealth, or over-the-phone genetic counseling

Aim II: Arm I (Genetic Counseling, Genetic Testing)

Genetic Testing GENETIC

Undergo genetic testing

Also known as: Genetic Analysis, Genetic Examination, Genetic Test, Genetic Testing, Genetic Testing

Aim II: Arm I (Genetic Counseling, Genetic Testing)

Internet-Based Intervention OTHER

Use web-based genetic education tool online

Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AIM 1: Medical oncologists, radiation oncologists and urologists spanning Veterans Affairs (VA), academic, and community settings
• 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

You may not qualify if:

• Age \< 18 years
• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Prostate Cancer Foundation: collaborator

Study Sites (5)

VA New York Harbor Health System- Manhattan Campus

New York, New York, 10010, United States

Location

New York University- Langone Health

New York, New York, 10016, United States

Location

Associated Medical Professions of New York

Syracuse, New York, 13210, United States

Location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Washington/ SCCA

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• 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.

  PMID: 38452310 DERIVED

• 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.

  PMID: 35710085 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as Topic; Genetic Counseling; Genetic Testing

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Techniques; Diagnostic Services; Preventive Health Services

Study Officials

• Veda Giri, MD

  Clinical Cancer Genetics Yale School of Medicine

  PRINCIPAL INVESTIGATOR

• Stacy Loeb, MD, MSc

  NYU- Langone Health, Manhattan VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: June 25, 2020
• Study Start: August 27, 2020
• Primary Completion: August 9, 2022
• Study Completion: September 10, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (5)