GENetic Education Risk Assessment and TEsting Study

NCT03762590 | Active Not Recruiting

• 1 other identifier: 18-222
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families. This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Up to 1,000 participants will be enrolled in this study.

Conditions

Candidates for Hereditary Pancreatic Cancer Testing

Keywords

Candidates for Hereditary Pancreatic Cancer Testing

Outcome Measures

Primary Outcomes (1)

• Change of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients

  Measure the effect that alternative methods of genetic education and delivery models have on the increase of genetic testing among family members of mutation positive PDAC patients, among family members of mutation positive individuals with a family history of PDAC and among first-degree relatives of PDAC patients in each arm of the intervention study. We will document how many relatives per family elect to undergo genetic testing and compare the results of this measure between both arms of the study.

  2 years

Secondary Outcomes (5)

• Level of cancer-risk distress

  Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention

• Increase of knowledge of genetic testing

  Immediately post intervention

• Factors in decision making

  Immediately post intervention

• Degree of family communication about genetic test results

  3-4 months post intervention, 15 months post intervention

• Uptake of surveillance for pancreatic, other associated cancers and health behaviors

  Baseline and 15 months post intervention

Study Arms (2)

Doxy.me plus Color Genomics Arm (Arm 1)

EXPERIMENTAL

* Participants in this arm will receive genetic education through an online platform called Doxy.me * The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor * After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing * Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website

Other: Doxy.me genetic education +/- Color Genomics genetic education

Color Genomics Only Arm (Arm 2)

EXPERIMENTAL

* Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video * After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing * Intervention is genetic education via Color Genomics website

Other: Color Genomics genetic education

Interventions

Doxy.me genetic education +/- Color Genomics genetic education OTHER

Doxy.me is a HIPAA compliant telemedicine platform that allows clinicians to provide education to remote patients. Genetic education via Doxy.me will consist of a pre-recorded genetic education video and a live interactive video conferencing session with a GENERATE genetic counselor. Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

Doxy.me plus Color Genomics Arm (Arm 1)

Color Genomics genetic education OTHER

Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.

Color Genomics Only Arm (Arm 2)

Eligibility Criteria

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

You may qualify if:

• Individual who is 18 years or older
• Individual who has signed the informed consent
• Individual with:
• A first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR a second-degree relative who has (or had) PDAC and has a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53
• The germline mutation and history of PDAC must be on the maternal side or paternal side of the individual's family
• Individual with a valid United States mailing address
• Individual with access to a healthcare provider and is willing to share genetic test results with that provider/the study team

You may not qualify if:

• Individual with a known cancer susceptibility gene
• Individual who has received genetic counseling for cancer risk within the last 3 years
• Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e. leukemia or lymphoma)
• Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
• Individual who is unwilling to complete baseline and follow-up questionnaires
• Individual who has a life expectancy of less than 1 year
• Individual with only APC I1307K mutation within their family
• Individual with only PMS2 exons 12-15 deletion mutation within their family

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Mayo Clinic: collaborator
• M.D. Anderson Cancer Center: collaborator
• Johns Hopkins University: collaborator
• University of California, San Diego: collaborator
• Weill Medical College of Cornell University: collaborator
• Stand Up To Cancer: collaborator
• Lustgarten Foundation: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Rodriguez NJ, Furniss CS, Yurgelun MB, Ukaegbu C, Constantinou PE, Fortes I, Caruso A, Schwartz AN, Stopfer JE, Underhill-Blazey M, Kenner B, Nelson SH, Okumura S, Zhou AY, Coffin TB, Uno H, Horiguchi M, Ocean AJ, McAllister F, Lowy AM, Klein AP, Madlensky L, Petersen GM, Garber JE, Lippman SM, Goggins MG, Maitra A, Syngal S. A Randomized Trial of Two Remote Health Care Delivery Models on the Uptake of Genetic Testing and Impact on Patient-Reported Psychological Outcomes in Families With Pancreatic Cancer: The Genetic Education, Risk Assessment, and Testing (GENERATE) Study. Gastroenterology. 2024 May;166(5):872-885.e2. doi: 10.1053/j.gastro.2024.01.042. Epub 2024 Feb 5.

  PMID: 38320723 DERIVED

Study Officials

• Sapna Syngal, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: May 8, 2019
• Primary Completion: December 12, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)