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

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Mayo Clinic

Status

Invitation-only

Conditions

Pancreatic Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06744595
24-006906 (Other Identifier)
NCI-2024-10177 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Health services research (EPIC message, genetic counseling)
Experimental group
Description:
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.
Treatment:
Other: Survey Administration
Procedure: Biospecimen Collection
Other: Genetic Counseling
Other: Electronic Health Record Review
Genetic: Genetic Testing for Cancer Risk
Other: Educational Intervention
Other: Genetic Counseling

Trial contacts and locations

1

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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