Recruitment

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