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

NCT06744595 — Not applicable, Enrolling by invitation, 50 participants, Mayo Clinic

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Evaluation of Genetic Testing for Patients With Known Family History of Pancreatic Cancer: A Pilot Study

Registry	NCT06744595
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	50 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Pancreatic Carcinoma
Interventions	Biospecimen Collection, Educational Intervention, Electronic Health Record Review, Genetic Counseling, Genetic Testing for Cancer Risk, Survey Administration (Procedure, other, genetic)
Dates	start 2025-02-12, primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2024-12-20, last updated 2026-06-04
Locations	1 site in United States

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Health services research (EPIC message, genetic counseling)	Experimental	Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Genetic Counseling; Genetic: Genetic Testing for Cancer Risk; Other: Survey Administration	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 genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.

Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection: Undergo collection of blood or salvia samples
Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Receive personalized EPIC message
Electronic Health Record Review (Other): Ancillary studies
Genetic Counseling (Other): Receive pre- and post-genetic test counseling
Genetic Testing for Cancer Risk (Genetic), also known as Cancer Risk Assessment with Genetic Testing and Counseling: Undergo standard of care (SOC) genetic testing
Survey Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines [Up to 75 days]: Will 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.

Secondary outcomes

Number of patients meeting NCCN guidelines [Up to 75 days]: Will determine if portal message communication can improve the number of patients who meet NCCN guidelines at Mayo Clinic in Florida and understand their experiences.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Florida	Jacksonville, Florida	United States

+Investigators

Adrianna D. Clapp, MD, Principal investigator, Mayo Clinic