Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2019-05-08
2027-12-31
Brief Summary
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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.
Detailed Description
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This research is being done to study the impact of different methods of teaching about and offering genetic testing to family members of pancreatic cancer patients who may carry a mutation.
Study arms:
Individuals will be randomized (like flipping a coin) by family to one of the two study arms to receive genetic education and elect to undergo genetic testing.
Individuals in Arm 1 (video conference platform plus Color Genomics) will receive genetic education via a pre-recorded educational video and interactive session with the study team through an internet-based platform.
Individuals in Arm 2 (Color Genomics Only) will receive genetic education from Color Genomics, Inc., an online, commercial genetic testing service.
Informed consent:
Participants will be asked to provide informed consent in order to join the study.
Study questionnaires:
Questionnaires will be given at baseline and throughout the duration of the study. Participants will be asked to complete questionnaires through the online study database, called REDCap (paper questionnaires are also an option). The baseline questionnaires will ask participants about their medical history, their experience with pancreatic cancer and other relevant health behaviors.
The follow-up questionnaires will ask about how much participants worried about cancer, how participants made choices, their knowledge gained and how much families shared genetic test results (if participants chose to get testing). The study will also ask about participants' choices to have pancreas exams and other surveillance (long-term screening) procedures, and their lifestyle choices after receiving the intervention.
Genetic testing:
GENERATE offers genetic testing at no cost to participants in the study. Color Genomics will provide the genetic testing services for the study. Participants will be directed to create a personal Color Genomics account that will allow them to enter their personal and family history information, keep track of their genetic testing kit and receive their genetic test results. Participants will be mailed an FDA-approved saliva collection kit from Color Genomics. When participants receive the kit in the mail, they will be able to use the kit's unique barcode number to activate it and link it to their online account. A video on the website will show participants how to provide a large enough saliva sample. It will also contain instructions for how to properly package and mail back the kit to Color Genomics using a pre-paid shipping package.
Getting test results:
It usually takes about 4-6 weeks to get the results back from this genetic test. Participants will receive an email letting them know that their results are available for review through their Color Genomics account or via a phone call with a Color Genomics genetic counselor.
Length of study:
The total participation on this study will last about 18 months, including follow-up. Participants may be contacted regarding participation in future studies.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Doxy.me plus Color Genomics Arm (Arm 1)
* 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
Doxy.me genetic education +/- Color Genomics genetic education
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.
Color Genomics Only Arm (Arm 2)
* 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
Color Genomics genetic education
Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.
Interventions
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Doxy.me genetic education +/- Color Genomics genetic education
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.
Color Genomics genetic education
Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
M.D. Anderson Cancer Center
OTHER
Johns Hopkins University
OTHER
University of California, San Diego
OTHER
Weill Medical College of Cornell University
OTHER
Stand Up To Cancer
OTHER
Lustgarten Foundation
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Sapna Syngal, MD, MPH
Principal Investigator
Principal Investigators
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Sapna Syngal, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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18-222
Identifier Type: -
Identifier Source: org_study_id