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

NCT06744595 | Enrolling By Invitation

• 2 other identifiers: 24-006906NCI-2024-10177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines

  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.

  Up to 75 days

Secondary Outcomes (1)

• Number of patients meeting NCCN guidelines

  Up to 75 days

Study Arms (1)

Health services research (EPIC message, genetic counseling)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Genetic Counseling; Genetic: Genetic Testing for Cancer Risk; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood or salvia samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Health services research (EPIC message, genetic counseling)

Educational Intervention OTHER

Receive personalized EPIC message

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health services research (EPIC message, genetic counseling)

Electronic Health Record Review OTHER

Ancillary studies

Health services research (EPIC message, genetic counseling)

Genetic Counseling OTHER

Receive pre-genetic test counseling

Health services research (EPIC message, genetic counseling)

Genetic Testing for Cancer Risk GENETIC

Undergo SOC genetic testing

Also known as: Cancer Risk Assessment with Genetic Testing and Counseling

Health services research (EPIC message, genetic counseling)

Survey Administration OTHER

Ancillary studies

Health services research (EPIC message, genetic counseling)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with an active or past history of pancreatic cancer
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Specimen Handling; Early Intervention, Educational; Educational Status; Methods; Genetic Counseling; Genetic Testing; Counseling

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Genetic Services; Genetic Techniques; Diagnostic Services; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Adrianna D. Clapp, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)