Clinical trialNAEnrolling by invitation
Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer
Evaluation of Genetic Testing for Patients With Known Family History of Pancreatic Cancer: A Pilot Study
- Outcome
- Ongoing
- Phase
- NA
- Status
- Enrolling by invitation
- Study type
- Interventional
- Start
- 12 February 2025
- Expected end
- 30 June 2026
- Enrollment
- 50 participants
- Sites
- 1
- Primary outcomes
- Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines
- Sponsor
- Other
- Results posted
- No
- Last update
- 4 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Procedure: Biospecimen Collection. Undergo collection of blood or salvia samples
Intervention public domain (ClinicalTrials.gov)
Other: Educational Intervention. Receive personalized EPIC message
Intervention public domain (ClinicalTrials.gov)
Other: Electronic Health Record Review. Ancillary studies
Intervention public domain (ClinicalTrials.gov)
Other: Genetic Counseling. Receive pre- and post-genetic test counseling
Intervention public domain (ClinicalTrials.gov)
Genetic: Genetic Testing for Cancer Risk. Undergo standard of care (SOC) genetic testing
Intervention public domain (ClinicalTrials.gov)
Other: Survey Administration. Ancillary studies
Arm public domain (ClinicalTrials.gov)
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.
Primary outcome public domain (ClinicalTrials.gov)
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. Time frame: Up to 75 days.
Secondary outcome public domain (ClinicalTrials.gov)
Number of patients meeting NCCN guidelines. Time frame: Up to 75 days.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 50 participants (estimated).