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Genetic Testing Education for Cancer Survivors (CATALYST Trial)
Phase < 1
Recruiting
Led By Anita Y Kinney, PhD, RN
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial, or prostate cancer
Have not previously undergone GT for hereditary cancer predisposition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-month, 6-months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to improve genetic education and testing for cancer survivors who may have a hereditary risk of cancer. The study will focus on developing and testing a digital intervention called CATALYST, which will
Who is the study for?
This trial is for cancer survivors with specific cancers such as breast, ovarian, prostate, colorectal and pancreatic. Participants should be interested in learning about their genetic risk of cancer through testing and education using smart technology.
What is being tested?
The study tests a digital tool called CATALYST (a relational assistant) against enhanced usual care to see if it improves genetic education and testing uptake among cancer survivors. Participants will be randomly placed into one of these two groups.
What are the potential side effects?
Since this is an observational study focusing on educational tools rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience emotional or psychological impacts from learning about their genetic risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of cancer.
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I have never had gene therapy for inherited cancer risk.
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I was diagnosed with specific cancers at a certain age or have a high-risk prostate cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-month, 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month, 6-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Genetic Testing Uptake
Secondary study objectives
Acceptance and Usability of the Relational Agent
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Relational Agent (RA)Experimental Treatment1 Intervention
RA participants will be provided with access to Alex, the RA. After completing the RA, RA participants can proceed directly to GT.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
EUC participants will be sent a clinical letter informing them of their increased risk of hereditary cancer, availability of GC and GT services, and contact information to schedule an appointment with a genetic counselor at the LIFE Center.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
450 Previous Clinical Trials
65,768 Total Patients Enrolled
Anita Y Kinney, PhD, RNPrincipal InvestigatorDirector, Center for Cancer Health Equity
5 Previous Clinical Trials
1,304 Total Patients Enrolled
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