80 Participants NeededMy employer runs this trial

Genetic Education for Pancreatic Cancer

(REGENERATE Trial)

TK
JB
Overseen ByJenna Beckwith, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test a remote approach to help people who may be at higher risk for pancreatic cancer learn about and decide whether to get genetic testing and a blood test that looks for signs of several cancers (MCED testing). The study is focused on Black, Latino/a, and Medicaid-enrolled individuals who may have had less access to cancer genetics and early detection services. About 80 participants, who reside in Massachusetts, will be assigned by chance to receive either online education alone or online education plus a phone call with a trained educator from the Pancreatic Cancer Action Network (PanCAN). After the education, participants can choose whether or not to have genetic testing and/or MCED testing. The main goal is to learn whether this approach is practical to carry out, acceptable to participants, and delivered as planned. Participants will complete 3 surveys during study participation.

Who Is on the Research Team?

NJ

Nicolette J Rodriguez, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for Black, Latino/a, and Medicaid-enrolled adults living in Massachusetts who may be at higher risk for pancreatic cancer and have had less access to genetic testing or early cancer detection services.

Inclusion Criteria

I am at least 50, or 10 years younger than my family's earliest pancreatic cancer diagnosis.
Current Medicaid enrollment and/or Black and/or Latino/a
I am willing to travel to Boston for further testing if needed.
See 6 more

Exclusion Criteria

Currently pregnant
Three members of the same family already enrolled in the study
Language other than English
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive either online education alone or online education plus a phone call with a trained educator about genetic testing and MCED testing.

1-2 weeks
1 visit (virtual or phone)

Decision-making and Testing

Participants decide whether to undergo genetic testing and/or MCED testing. Testing is facilitated by the study team.

Up to 3 months

Follow-up

Participants are monitored for safety and effectiveness after testing, including follow-up surveys and potential diagnostic workup for positive results.

3-4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Online educational materials
  • Telephone education session

Trial Overview

The study compares two ways of providing education about genetic and blood tests for cancer: one group gets online materials only, while the other also receives a phone session with an educator. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Telephone education session plus online educational materialsExperimental Treatment2 Interventions
Group II: Online educational materials onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Pancreatic Cancer Action Network

Collaborator

Trials
6
Recruited
10,000+

Exact Science Corporation

Collaborator

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Winn Career Development Award

Collaborator