Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial

Pancreatic ductal adenocarcinoma (PDAC) is frequently diagnosed at advanced stages andhas poor survival. Approximately 10% of patients with PDAC have a pathogenic germlinevariant in a cancer gene, and national guidelines recommend genetic testing in patientswith PDAC and their at‐risk relatives. Surveillance in individuals at risk for PDAC hasbeen associated with earlier‐stage detection and improved survival. However, uptake ofgenetic testing among individuals at risk for hereditary cancer syndromes is often low,and this gap is especially pronounced in Black, Latino/a, and Medicaid‐enrolledpopulations. 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 earlydetection (MCED) education/testing.The REGENERATE Feasibility Trial is a randomized feasibility study evaluating a novelintervention consisting of phone‐based navigation delivered through a trusted nationalpancreatic cancer organization, PanCAN, compared with routine online educationalmaterials alone. The study will assess whether this approach can improve uptake ofgermline genetic testing and MCED testing among individuals at risk for PDAC who haveobstacles to healthcare access. The trial specifically focuses on Black, Latino/a, andMedicaid‐enrolled individuals at risk for PDAC who reside in Massachusetts, reflectingthe 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 HCCstudy with collaborating partners assisting with study outreach. Participants must livein Massachusetts, speak English, have internet access, and be willing to travel toDana‐Farber Cancer Institute in Boston for diagnostic testing if an MCED result indicatespossible malignancy. Eligible participants must be aged 50 years or older or within 10years of the earliest PDAC diagnosis in the family, and must be currently enrolled inMedicaid and/or identify as Black and/or Latino/a, with no prior PDAC‐related genetictesting.After consent and completion of the baseline survey, participants will be randomizedthrough REDCap to 1 of 2 study arms. In the online education arm, participants willreceive links to the testing company's educational websites and review materials at theirown pace. In the PanCAN telephone education arm, a trained PanCAN educator will conduct ascheduled telephone session. The telephone session includes approximately 10 minutes ofeducation about pancreatic cancer, genetic risk, and genetic testing, followed during thesame call by approximately 10 minutes of education about the risks, benefits, andlimitations of MCED testing. After either the phone session or online review,participants complete a post‐education survey assessing satisfaction, knowledge, andpreparation for decision‐making. Receipt of genetic testing and/or MCED testing isoptional, and participants may take up to 3 months to opt in to testing if accrualremains open.For participants who choose genetic testing, the study team will facilitate orderingthrough the testing company, which will mail a saliva kit to the participant's home. Forparticipants who choose MCED testing, the testing company will arrange either homephlebotomy or blood collection at a local facility based on participant preference.Genetic and MCED results are returned directly to the study team. Negative results aregenerally communicated by email and mail. Positive genetic results trigger telephonefollow‐up from a Dana‐Farber clinical genetic counselor for clinical navigation.Participants with a positive MCED result will be contacted for phone, virtual, orin‐person follow‐up with a Dana‐Farber provider familiar with MCED testing and invited toDana‐Farber for diagnostic workup until resolution. Recommended workup may includecontrast‐enhanced CT imaging and, if needed, PET‐CT or other targeted follow‐upprocedures or labs based on clinical context.The primary objectives for both the genetic education and MCED education components arefeasibility, acceptability, and fidelity. Feasibility outcomes include completion ofgermline genetic testing, completion of MCED testing, provision of a testing decision,study enrollment, and retention. Acceptability will be measured with the 3‐item ClientSatisfaction Questionnaire (CSQ‐3). Fidelity will be assessed only in the telephoneeducation arm using session checklists evaluating adherence to planned content andduration; selected sessions will be audio‐recorded to validate checklist completion andmonitor adherence. Exploratory aims will summarize patient‐reported outcomes related togenetic risk, genetic testing, and MCED testing, with no formal hypothesis testingplanned for these exploratory analyses.The study defines the intervention as feasible if at least 30% of enrolled participantscomplete germline genetic testing and at least 30% complete MCED testing. Enrollmentfeasibility will be considered promising if at least 60% of eligible participants enroll,and decision‐making feasibility if at least 60% of enrolled participants provide atesting decision. Retention will be considered promising if at least 60% of enrolledparticipants complete follow‐up. Acceptability will be considered adequate if the meanCSQ‐3 score is at least 3, and fidelity will be considered adequate if at least 90% ofparticipants in the telephone arm complete a session in which at least 90% of requirededucational content is reviewed.Study activities are conducted primarily remotely. Recruitment will use social mediaadvertisements and outreach through PanCAN, Dana‐Farber Cancer Institute, Boston‐areacommunity health clinics, and community organizations serving target populations.Participant‐related data, including screening information, surveys, and test results,will be stored in a secure password‐protected REDCap database with access restricted tostudy personnel. Participants will be assigned unique study IDs, and no data or specimenswill be banked as part of this study. The protocol anticipates no greater than minimalrisk, although risks include distress related to genetic findings, blood draw‐relateddiscomfort, questionnaire‐related emotional distress, false‐positive MCED results, andrisks related to follow‐up procedures and labs after a positive MCED result.The expected duration of participation is approximately 6 to 9 months and includesconsent, baseline assessment, education, specimen return and testing, result disclosure,and follow‐up. All participants, including those who decline testing, will be asked tocomplete a follow‐up survey 3 to 4 months after their last study step. Enrollment isexpected to take about 18 months.