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

Thomas Jefferson University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04447703

20G.013

JT 14902 (Other Identifier)

19CHAL05 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 (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.

Enrollment: 346 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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346 participants in 3 patient groups

Aim I (Interview)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Internet Based Intervention

Other: Survey Administration

Other: Interview

Other: Survey Administration

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

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Genetic Counseling

Other: Genetic Counseling

Other: Survey Administration

Genetic: Genetic Testing

Genetic: Genetic Testing

Other: Survey Administration

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

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Genetic Counseling

Other: Genetic Counseling

Other: Survey Administration

Other: Internet-Based Intervention

Genetic: Genetic Testing

Genetic: Genetic Testing

Other: Survey Administration