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Web-Based Genetic Education for Prostate Cancer
N/A
Waitlist Available
Led By Stacy Loeb, MD, MSc
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Metastatic disease
- Biochemical recurrence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a mobile-friendly patient history collection and genetic education tool to improve healthcare providers' understanding of prostate cancer genetic testing. It is also comparing traditional genetic counseling versus a web-based genetic education (WBGE) tool to provide information about genetic testing to men with prostate cancer.
Who is the study for?
This trial is for English-speaking men aged 18 or older with prostate cancer who have access to a computer and the web. They must meet certain clinical criteria like advanced disease stage, high PSA levels, or specific family history of cancer. It's not for those with mental impairments affecting consent, non-English speakers, minors, or those who've had prior genetic testing.Check my eligibility
What is being tested?
The TARGET Study tests a mobile tool that collects patient history and educates about genetic testing versus traditional counseling. It aims to help healthcare providers identify patients for potential genetic mutations related to prostate cancer and decide on testing.See study design
What are the potential side effects?
Since this study involves interviews, an internet-based intervention tool, surveys and potentially genetic counseling/testing rather than medication or invasive procedures, typical medical side effects are not expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to other parts of my body.
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My cancer has returned, indicated by blood tests.
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I have at least 2 close relatives with breast or prostate cancer.
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My cancer is at a high grade (4 or higher).
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I have a close relative diagnosed with specific cancers before age 50.
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My breast cancer is of a specific type (intraductal or cribriform).
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My cancer is at least stage T3a.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decisional Conflict (Aim II)
User Testing of the Provider Tool - (Aim I)
Secondary outcome measures
Cancer Genetics Knowledge (Aim II)
Genetic Testing Uptake (Aim II)
Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)
Other outcome measures
Diet (Aim II)
Literacy (Aim II)
Numeracy (Aim II)
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)Experimental Treatment4 Interventions
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.
Group II: Aim I (Interview)Experimental Treatment3 Interventions
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.
Group III: Aim II: Arm I (Genetic Counseling, Genetic Testing)Active Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Genetic Testing
2021
Completed Phase 1
~1510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,321 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,368 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,526 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,434 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone genetic testing for inherited cancer risk.I am a man over 18 with prostate cancer, have computer and web access.My cancer has spread to other parts of my body.My cancer has returned, indicated by blood tests.I have at least 2 close relatives with breast or prostate cancer.My cancer is at a high grade (4 or higher).I have a close relative diagnosed with specific cancers before age 50.My breast cancer is of a specific type (intraductal or cribriform).My family has had 3 or more cases of certain cancers on the same side, diagnosed before age 50.A close male relative was diagnosed with prostate cancer before 60.I am able to understand and make decisions about my health care.I do not speak English.My cancer is at least stage T3a.I am under 18 years old.You have Ashkenazi Jewish heritage.
Research Study Groups:
This trial has the following groups:- Group 1: Aim I (Interview)
- Group 2: Aim II: Arm I (Genetic Counseling, Genetic Testing)
- Group 3: Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals still join this trial at the present time?
"Clinicaltrials.gov indicates that this trial, first posted on August 27th 2020 and last modified on October 25th 2022 is no longer enrolling candidates. Nevertheless, there are 3660 other trails currently recruiting participants."
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