An interventional study of Interview and Internet Based Intervention in Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma and Stage IIIB Prostate Cancer AJCC v8, sponsored by Thomas Jefferson University. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Health services research
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 346 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
AIM 2: Any English speaking man >= 18 with PCA who has computer and web-access and meets any one of the following:
Family history criteria (see below) ** Family history: If any one of the following levels are met, the person is eligible:
Exclusion Criteria
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.
Other: Interview · Other: Internet Based Intervention · Other: Survey Administration
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.
Other: Genetic Counseling · Genetic: Genetic Testing · Other: Survey Administration
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. Patient may then undergo genetic testing. Patient may cross-over to Arm I to see a genetic counselor.
Other: Genetic Counseling · Other: Internet-Based Intervention · Genetic: Genetic Testing · Other: Survey Administration
Attend Interview
Use web-based genetic education tool online
Ancillary Studies
Receive in-person, telehealth, or over-the-phone genetic counseling
Undergo genetic testing
Also known as: Genetic Analysis, Genetic Examination, Genetic Test, Genetic Testing, Genetic Testing
Ancillary Studies
Receive in-person, telehealth, or over-the-phone genetic counseling
Use web-based genetic education tool online
Undergo genetic testing
Also known as: Genetic Analysis, Genetic Examination, Genetic Test, Genetic Testing, Genetic Testing
Ancillary Studies
User Testing of the Provider Tool - (Aim I)
Provider perspectives will include: (1) whether the target population can use the tool in the way it was intended (i.e., to perform patient history collection to determine consideration for germline testing), and (2) interaction with this tool affects the user's cognitive representation of genetic testing for prostate cancer (PCA). To evaluate the first point, will collect initial information from participants regarding their experience with the guidelines for genetic testing and how they collect data on family history. Will evaluate participants' mental model for germline testing and how they identify suitable candidates before interaction with the tool. Will use a cognitive concept mapping technique, which can be used to formalize a person's cognitive representation for complex topics. Feedback from this testing will be used to iteratively refine the tool while it is being used by providers to identify patients randomized trial in Aim II.
Time frame: Up to 6 months
Decisional Conflict (Aim II)
Will be assessed for non-inferiority between study arms. Evaluated using the O'Connor decisional conflict scale, which captures sub-scores over 16-questions for uncertainty, feeling of being informed, values clarity, support, and effective decision making on a 5-point Likert scale
Time frame: Up to 6 months
Cancer Genetics Knowledge (Aim II)
Assessed using pre- and post-intervention surveys. Cancer genetics knowledge will be adapted from Erblich. et al (2005) for relevance to PCA genetics (23 True/False questions) (Cronbach's alpha = 0.92).
Time frame: Up to 6 Months
Genetic Testing Uptake (Aim II)
Assessed using pre-and post-intervention surveys
Time frame: Up to 5 years
Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)
Will capture men's satisfaction with each arm using the Satisfaction with Genetic Counseling Scale at the end of pre-test genetic counseling or after viewing the web tool. This 6-item scale includes questions such as: "My genetic counselor seemed to understand the stresses I was facing," and "The genetic counseling session was valuable to me" rated on a 5-point Likert scale (Cronbach's alpha 0.7-0.88). The questions will be adapted for web-based pretest genetic education such as "This webtool addressed all of the concerns I had" or "The webtool was valuable to me".
Time frame: After viewing the web tool
Understanding of personal genetic test results (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
Sharing of genetic information with families (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
Literacy (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
Numeracy (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
Diet (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
Physical activity (Aim II)
Assessed using pre- and post-intervention surveys.
Time frame: Up to 5 years
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Jefferson University