Genetic Education for Cancer Testing (GENERATE Trial)

Palo Alto (17 mi)

Overseen bySapna Syngal, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families. This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Up to 1,000 participants will be enrolled in this study.

Eligibility Criteria

The GENERATE Study is for adults with a close relative who had pancreatic cancer and may carry certain genetic mutations. Participants must be willing to provide saliva samples, complete questionnaires, share results with their healthcare provider, and have not received recent genetic counseling or blood transfusions.

Inclusion Criteria

I am 18 years old or older.

I have a family history of pancreatic cancer and a known genetic mutation.

Exclusion Criteria

I am unable to sign the consent form due to a mental health condition.

I have a gene that increases my risk for cancer.

My family's genetic mutation is limited to PMS2 exons 12-15 deletion.

I am willing to complete all required questionnaires.

I've had a bone marrow transplant, recent blood transfusion, or have leukemia/lymphoma.

Treatment Details

This study tests two methods of genetic education to see if they increase the rate of genetic testing in families at risk for inherited pancreatic cancer. It involves FDA-approved testing processed in a certified lab and aims to enroll up to 1,000 participants.

2Treatment groups

Experimental Treatment

Group I: Doxy.me plus Color Genomics Arm (Arm 1)Experimental Treatment1 Intervention

* Participants in this arm will receive genetic education through an online platform called Doxy.me * The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor * After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing * Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website

Group II: Color Genomics Only Arm (Arm 2)Experimental Treatment1 Intervention

* Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video * After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing * Intervention is genetic education via Color Genomics website