Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial (REGENERATE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 arm, a trained PanCAN educator will conduct a scheduled telephone session. The telephone session includes approximately 10 minutes of education about pancreatic cancer, genetic risk, and genetic testing, followed during the same call by approximately 10 minutes of education about the risks, benefits, and limitations of MCED testing. After either the phone session or online review, participants complete a post-education survey assessing satisfaction, knowledge, and preparation for decision-making. Receipt of genetic testing and/or MCED testing is optional, and participants may take up to 3 months to opt in to testing if accrual remains open.
For participants who choose genetic testing, the study team will facilitate ordering through the testing company, which will mail a saliva kit to the participant's home. For participants who choose MCED testing, the testing company will arrange either home phlebotomy or blood collection at a local facility based on participant preference. Genetic and MCED results are returned directly to the study team. Negative results are generally communicated by email and mail. Positive genetic results trigger telephone follow-up from a Dana-Farber clinical genetic counselor for clinical navigation. Participants with a positive MCED result will be contacted for phone, virtual, or in-person follow-up with a Dana-Farber provider familiar with MCED testing and invited to Dana-Farber for diagnostic workup until resolution. Recommended workup may include contrast-enhanced CT imaging and, if needed, PET-CT or other targeted follow-up procedures or labs based on clinical context.
The primary objectives for both the genetic education and MCED education components are feasibility, acceptability, and fidelity. Feasibility outcomes include completion of germline genetic testing, completion of MCED testing, provision of a testing decision, study enrollment, and retention. Acceptability will be measured with the 3-item Client Satisfaction Questionnaire (CSQ-3). Fidelity will be assessed only in the telephone education arm using session checklists evaluating adherence to planned content and duration; selected sessions will be audio-recorded to validate checklist completion and monitor adherence. Exploratory aims will summarize patient-reported outcomes related to genetic risk, genetic testing, and MCED testing, with no formal hypothesis testing planned for these exploratory analyses.
The study defines the intervention as feasible if at least 30% of enrolled participants complete germline genetic testing and at least 30% complete MCED testing. Enrollment feasibility will be considered promising if at least 60% of eligible participants enroll, and decision-making feasibility if at least 60% of enrolled participants provide a testing decision. Retention will be considered promising if at least 60% of enrolled participants complete follow-up. Acceptability will be considered adequate if the mean CSQ-3 score is at least 3, and fidelity will be considered adequate if at least 90% of participants in the telephone arm complete a session in which at least 90% of required educational content is reviewed.
Study activities are conducted primarily remotely. Recruitment will use social media advertisements and outreach through PanCAN, Dana-Farber Cancer Institute, Boston-area community 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 to study personnel. Participants will be assigned unique study IDs, and no data or specimens will be banked as part of this study. The protocol anticipates no greater than minimal risk, although risks include distress related to genetic findings, blood draw-related discomfort, questionnaire-related emotional distress, false-positive MCED results, and risks related to follow-up procedures and labs after a positive MCED result.
The expected duration of participation is approximately 6 to 9 months and includes consent, baseline assessment, education, specimen return and testing, result disclosure, and follow-up. All participants, including those who decline testing, will be asked to complete a follow-up survey 3 to 4 months after their last study step. Enrollment is expected to take about 18 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tia Kauffman, MPH
- Phone Number: 857-215-1892
- Email: tial_kauffman@dfci.harvard.edu
Study Contact Backup
- Name: Jenna Beckwith, MPH
- Phone Number: 857-215-1892
- Email: JennaB_Beckwith@dfci.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Contact:
- Jenna Beckwith, MPH
- Phone Number: 857-215-1892
- Email: JennaB_Beckwith@dfci.harvard.edu
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Contact:
- Ishmarie Colon-Rivera, MPH
- Phone Number: 857-215-1892
- Email: regeneratestudy@dfci.harvard.edu
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Principal Investigator:
- Nicolette J Rodriguez, MD, MPH
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Sub-Investigator:
- Sapna Syngal, MD, MPH
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Sub-Investigator:
- Elizabeth O'Donnell, MD
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Sub-Investigator:
- Catherine Marinac, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Telephone education session plus online educational materials
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.
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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.
|
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Active Comparator: Online educational materials only
Participants will be emailed links to online educational materials from the testing company
|
Participants will receive links to test information provided by the testing company.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of completion of genetic testing and MCED testing
Time Frame: Within 6 months of randomization
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The intervention will be feasible if at least 30% of enrolled participants complete germline genetic testing and at least 30% complete MCED testing.
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Within 6 months of randomization
|
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Acceptability of the education delivery
Time Frame: Within 6 months of the educational information
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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.
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Within 6 months of the educational information
|
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Fidelity of the intervention
Time Frame: Assessed within 6 months of the education session
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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
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Assessed within 6 months of the education session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolette J Rodriguez, MD, MPH, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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