Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- NA
- Status
- Recruiting
- Start
- 2026-10-15
- End
- 2029-03
- Enrollment
- 80
- Sites
- 1
- Sponsor class
- OTHER
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Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
Pancreatic ductal adenocarcinoma (PDAC) is frequently diagnosed at advanced stages and has poor survival. Approximately 10% of patients with PDAC have a pathogenic germline variant in a cancer gene, and national guidelines recommend genetic testing in patients with PDAC and their at-risk relatives. Surveillance in individuals at risk for PDAC has been associated with earlier-stage detection and improved survival. However, uptake of genetic testing among individuals at risk for hereditary cancer syndromes is often low, and this gap is especially pronounced in Black, Latino/a, and Medicaid-enrolled populations. This study is designed to address this gap by evaluating a lower-cost, patient-driven remote model for PDAC genetic education/testing and multi-cancer early detection (MCED) education/testing. The REGENERATE Feasibility Trial is a randomized feasibility study evaluating a novel intervention consisting of phone-based navigation delivered through a trusted national pancreatic cancer organization, PanCAN, compared with routine online educational materials alone. The study will assess whether this approach can improve uptake of germline genetic testing and MCED testing among individuals at risk for PDAC who have obstacles to healthcare access. The trial specifically focuses on Black, Latino/a, and Medicaid-enrolled individuals at risk for PDAC who reside in Massachusetts, reflecting the study goal of improving access to cancer genetics and early detection services. The study plans to randomize 80 individuals at risk for PDAC, approximately 40 per arm, and will enroll until 80 participants have been randomized. This is a single-site HCC study with collaborating partners assisting with study outreach. Participants must live in Massachusetts, speak English, have internet access, and be willing to travel to Dana-Farber Cancer Institute in Boston for diagnostic testing if an MCED result indicates possible malignancy. Eligible participants must be aged 50 years or older or within 10 years of the earliest PDAC diagnosis in the family, and must be currently enrolled in Medicaid and/or identify as Black and/or Latino/a, with no prior PDAC-related genetic testing. After consent and completion of the baseline survey, participants will be randomized through REDCap to 1 of 2 study arms. In the online education arm, participants will receive links to the testing company's educational websites and review materials at their own pace. In the PanCAN telephone education …
Intervention · public domain (ClinicalTrials.gov) · T1
Behavioral: Telephone education session. Participants will receive a telephone call from a trained navigator at PanCAN to provide \~20mins of information about genetic testing and MCED testing.
Intervention · public domain (ClinicalTrials.gov) · T1
Behavioral: Online educational materials. Participants will receive links to test information provided by the testing company.
Arm · public domain (ClinicalTrials.gov) · T1
Telephone education session plus online educational materials (experimental): Participants 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.
Arm · public domain (ClinicalTrials.gov) · T1
Online educational materials only (active comparator): Participants will be emailed links to online educational materials from the testing company
Primary outcome · public domain (ClinicalTrials.gov) · T1
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. Time frame: Within 6 months of randomization.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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. Time frame: Within 6 months of the educational information.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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 Time frame: Assessed within 6 months of the education session.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 80 participants (estimated).