Clinical trial NCT04447703: Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Official title: Technology-Enhanced Acceleration of Germline Evaluation for Therapy - The TARGET Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2020-06-25
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (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.

Eligibility 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)

Primary outcomes:
measure: User Testing of the Provider Tool - (Aim I)
timeFrame: Up to 6 months
measure: Decisional Conflict (Aim II)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Cancer Genetics Knowledge (Aim II)
timeFrame: Up to 6 Months
measure: Genetic Testing Uptake (Aim II)
timeFrame: Up to 5 years
measure: Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)
timeFrame: After viewing the web tool
Other outcomes:
measure: Understanding of personal genetic test results (Aim II)
timeFrame: Up to 5 years
measure: Sharing of genetic information with families (Aim II)
timeFrame: Up to 5 years
measure: Literacy (Aim II)
timeFrame: Up to 5 years
measure: Numeracy (Aim II)
timeFrame: Up to 5 years
measure: Diet (Aim II)
timeFrame: Up to 5 years
measure: Physical activity (Aim II)
timeFrame: Up to 5 years
Locations:
city: New York
country: United States
facility: VA New York Harbor Health System- Manhattan Campus
state: New York
city: New York
country: United States
facility: New York University- Langone Health
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professions of New York
state: New York
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington/ SCCA
state: Washington
Study officials:
affiliation: Clinical Cancer Genetics Yale School of Medicine
name: Veda Giri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU- Langone Health, Manhattan VA Hospital
name: Stacy Loeb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.