Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial
REGENERATE
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
Study Completion
Last participant's last visit for all outcomes
March 1, 2029
August 26, 2026
August 1, 2026
2 years
August 24, 2026
August 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of completion of genetic testing and MCED testing
The intervention will be feasible if at least 30% of enrolled participants complete germline genetic testing and at least 30% complete MCED testing.
Within 6 months of randomization
Acceptability of the education delivery
Acceptability will be assessed using the 3-item Client Satisfaction Questionnaire-3 (CSQ-3), with a mean score of at least 3 indicating acceptable intervention acceptability.
Within 6 months of the educational information
Fidelity of the intervention
Fidelity will be considered adequate if at least 90% of participants in the telephone arm complete a session in which at least 90% of the required educational contents is reviewed
Assessed within 6 months of the education session
Study Arms (2)
Telephone education session plus online educational materials
EXPERIMENTALParticipants will receive information about genetic testing and MCED testing through a telephone education session, in addition to receiving emailed links to online educational materials from the testing company.
Online educational materials only
ACTIVE COMPARATORParticipants will be emailed links to online educational materials from the testing company
Interventions
Participants will receive a telephone call from a trained navigator at PanCAN to provide \~20mins of information about genetic testing and MCED testing.
Participants will receive links to test information provided by the testing company.
Eligibility Criteria
You may qualify if:
- Aged 50 years or older OR 10 years younger than the earliest PDAC diagnosis in a family member
- Current Medicaid enrollment and/or Black and/or Latino/a
- Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if MCED screening test indicates possible malignancy
- Living in the state of Massachusetts
- No prior multi-gene panel genetic testing related to PDAC genetic risk
- Internet access to complete study surveys
- English speaking
- Willing to complete study surveys
- At least one first-degree relative with a PDAC diagnosis by participant report OR Any blood relative with a known pathogenic or likely pathogenic variant in a cancer susceptibility gene related to PDAC by participant report (e.g. ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, STK11, or TP53)
You may not qualify if:
- Less than age 50 years or age not within 10 years of the earliest PDAC diagnosis in their family
- Cancer diagnosis in the last 3 years (excluding non-melanoma skin cancers)
- Currently pregnant
- Insurance other than Medicaid or race/ethnicity other than Black or Latino/a
- Prior genetic testing related to PDAC genetic risk
- Genetic counseling in the last 3 years
- Living in a state other than Massachusetts
- Language other than English
- Three members of the same family already enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Pancreatic Cancer Action Networkcollaborator
- Exact Science Corporationcollaborator
- Dana-Farber Cancer Institutecollaborator
- Winn Career Development Awardcollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolette J Rodriguez, MD, MPH
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
August 24, 2026
First Posted
August 26, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
August 26, 2026
Record last verified: 2026-08