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

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 (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.

Inclusion criteria

• 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

Exclusion criteria

• 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)