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Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer


2025-02-12


2026-06-30


2026-06-30


40

Study Overview

Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer

This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of pancreatic cancer. Approximately 10% of pancreatic cancer cases are genetically linked and therefore, if a gene is found that could put a patient at risk, it could guide the patient to obtain more frequent screening for pancreatic cancer and possibly detect it earlier when it is more treatable. The current National Comprehensive Cancer Network (NCCN) guidelines suggest patients with a first-degree relative (parent, sibling, child) with pancreatic cancer be referred for a genetics consultation to discuss genetic testing if the affected family member cannot be tested. Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be an effective method to increase patients' understanding of their pancreatic cancer risk and the NCCN guidelines. Genetic counseling is provided by an expert in hereditary disorders. The patient's family and personal medical history may be discussed, and counseling may lead to genetic testing. Personalized education and genetic counseling may increase genetic testing in patients with a known family history of pancreatic cancer.

PRIMARY OBJECTIVES: I. Perform Housing-Based Socioeconomic Status (HOUSES) index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. II. Offer 40 patients who did not have appropriate NCCN intervention the opportunity to have a genetic consultation (to consider genetic testing). III. Survey patients on their knowledge and experiences of genetic testing based on family history and their decision-making when offered genetic counseling and testing. OUTLINE: Patients receive a personalized message through the Mayo portal (EPIC) with education on the NCCN guidelines for genetic counseling and an offer for standard of care (SOC) genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.

  • Pancreatic Carcinoma
  • PROCEDURE: Biospecimen Collection
  • OTHER: Educational Intervention
  • OTHER: Electronic Health Record Review
  • OTHER: Genetic Counseling
  • OTHER: Genetic Counseling
  • GENETIC: Genetic Testing for Cancer Risk
  • OTHER: Survey Administration
  • 24-006906
  • NCI-2024-10177 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • 24-006906 (OTHER Identifier) (OTHER: Mayo Clinic Institutional Review Board)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-12-17  

N/A  

2025-07-02  

2024-12-17  

N/A  

2025-07-03  

2024-12-20  

N/A  

2025-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Health Services Research


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Health services research (EPIC message, genetic counseling)

Patients receive a personalized message through EPIC with education on the NCCN guidelines for genetic counseling and an offer for SOC genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC

PROCEDURE: Biospecimen Collection

  • Undergo collection of blood or salvia samples

OTHER: Educational Intervention

  • Receive personalized EPIC message

OTHER: Electronic Health Record Review

  • Ancillary studies

OTHER: Genetic Counseling

  • Receive pre-genetic test counseling

OTHER: Genetic Counseling

  • Receive post-genetic test counseling

GENETIC: Genetic Testing for Cancer Risk

  • Undergo SOC genetic testing

OTHER: Survey Administration

  • Ancillary studies
Primary Outcome MeasuresMeasure DescriptionTime Frame
Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelinesWill determine whether demographic factors, including socioeconomic status, affect the likelihood of a patient meeting NCCN guidelines regarding genetic counseling for those with a family history of pancreatic cancer.Up to 75 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Number of patients meeting NCCN guidelinesWill determine if portal message communication can improve the number of patients who meet NCCN guidelines at Mayo Clinic in Florida and understand their experiences.Up to 75 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    Inclusion Criteria:

  • Age: 18-75 years of age
  • First-degree relative with pancreatic cancer listed in the EPIC family history tool
  • Active patient at Mayo Clinic Florida (MCF) (visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology)

  • Exclusion Criteria:

  • Patients not meeting the inclusion criteria as defined above
  • Patients with an active or past history of pancreatic cancer
  • Patients who are pregnant or breastfeeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Adrianna D. Clapp, MD, Mayo Clinic

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available