NCT04447703

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Interview	Attend Interview
OTHER	Internet Based Intervention	Use web-based genetic education tool online
OTHER	Survey Administration	Ancillary Studies
OTHER	Genetic Counseling	Receive in-person, telehealth, or over-the-phone genetic counseling
GENETIC	Genetic Testing	Undergo genetic testing
OTHER	Survey Administration	Ancillary Studies
OTHER	Genetic Counseling	Receive in-person, telehealth, or over-the-phone genetic counseling
OTHER	Internet-Based Intervention	Use web-based genetic education tool online
GENETIC	Genetic Testing	Undergo genetic testing
OTHER	Survey Administration	Ancillary Studies

Timeline

• Start date: 2020-08-27
• Primary completion: 2022-08-09
• Completion: 2024-09-10
• First posted: 2020-06-25
• Last updated: 2025-12-02

Locations

5 sites across 1 country: United States