Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Prostate Cancer
- Stage IIB Prostate Cancer
- Stage IIC Prostate Cancer
- Stage III Prostate Cancer
- Stage IIIA Prostate Cancer
- Stage IIIB Prostate Cancer
- Stage IIIC Prostate Cancer
- Stage IV Prostate Cancer
- Stage IVA Prostate Cancer
- Stage IVB Prostate Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Perform user-testing of an education and patient history collection mobile tool among medical oncologist, radiation oncologist, and urologists across study practice settings, including Veterans Affairs to address genetic referrals needs (n=10 providers). (Provider-focused) II....
PRIMARY OBJECTIVES: I. Perform user-testing of an education and patient history collection mobile tool among medical oncologist, radiation oncologist, and urologists across study practice settings, including Veterans Affairs to address genetic referrals 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: 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.
Tracking Information
- NCT #
- NCT04447703
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Veda Giri, MD Thomas Jefferson University