Genetic Counseling for Family History of Pancreatic Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pancreatic cancer, Pregnant, Breastfeeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Personalized Education and Genetic Counseling for family history of pancreatic cancer?

Research shows that genetic counseling and testing can significantly increase the identification of genetic mutations linked to pancreatic cancer, which can help in early detection and treatment planning. Additionally, integrating genetic counseling in clinical settings has been shown to improve patient engagement and compliance with recommended testing. ^{1 2 3 4 5}

Is genetic counseling for family history of pancreatic cancer safe?

The research does not provide specific safety data for genetic counseling, but it is generally considered a safe process as it involves discussing family history and potential genetic risks with a counselor. ^{1 2 3 4 6}

How does the treatment 'Personalized Education and Genetic Counseling' differ from other treatments for pancreatic cancer?

This treatment is unique because it focuses on providing personalized education and genetic counseling to individuals with a family history of pancreatic cancer, helping them understand their risk and make informed decisions about their health. Unlike traditional treatments that target the cancer itself, this approach aims to identify high-risk individuals through family history and genetic testing, potentially leading to early detection and prevention strategies. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Adrianna D. Clapp, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with a family history of pancreatic cancer, specifically those who have a first-degree relative (parent, sibling, child) affected by the disease. It aims to see if personalized education and genetic counseling can increase their participation in genetic testing.

Inclusion Criteria

Active patient at Mayo Clinic Florida (MCF) with visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology

A close family member has had pancreatic cancer.

Exclusion Criteria

Patients not meeting the inclusion criteria as defined above

Patients who are pregnant or breastfeeding

I have or had pancreatic cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Counseling

Participants receive personalized education on NCCN guidelines and pre-genetic test counseling

Up to 75 days

1 visit (virtual)

Genetic Testing

Participants may optionally undergo SOC genetic testing and provide blood or saliva samples

1-2 weeks

Follow-up

Participants receive post-genetic test counseling and are monitored for understanding and adherence to NCCN guidelines

4 weeks

Treatment Details

Interventions

• Personalized Education and Genetic Counseling

Trial Overview The study tests whether providing tailored educational materials about pancreatic cancer risks and guidelines, along with professional genetic counseling, encourages patients to undergo genetic testing that could help in early detection.

Participant Groups

Group I: Health services research (EPIC message, genetic counseling) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Poland pubmed.ncbi.nlm.nih.gov

Patient perspective on the value of genetic counselling for familial pancreas cancer. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Mainstreaming germline genetic testing for patients with pancreatic cancer increases uptake. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Referral frequency, attrition rate, and outcomes of germline testing in patients with pancreatic adenocarcinoma. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The prevention and genetics of pancreatic cancer: a programmatic approach. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of comprehensive family history and genetic analysis in the multidisciplinary pancreatic tumor clinic setting. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Self-Reported Questionnaire Detects Family History of Cancer in a Pancreatic Cancer Screening Program. [2018]

7. Poland pubmed.ncbi.nlm.nih.gov

Familial pancreatic cancer: a case study and review of the psychosocial effects of diagnoses on families. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Identification of individuals at high-risk for pancreatic cancer using a digital patient-input tool combining family cancer history screening and new-onset diabetes. [2023]