CompletedNot Applicable

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

United States346 participantsStarted 2020-08-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

User Testing of the Provider Tool - (Aim I)

Timeframe: Up to 6 months

Decisional Conflict (Aim II)

Timeframe: Up to 6 months

Trial details

NCT IDNCT04447703

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-09

View on ClinicalTrials.gov More Biochemically Recurrent Prostate Carcinoma trials