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Trial record 1 of 1 for:    NCT03762590
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GENetic Education Risk Assessment and TEsting Study (GENERATE)

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ClinicalTrials.gov Identifier: NCT03762590
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Johns Hopkins University
University of California, San Diego
Mayo Clinic
Weill Cornell Medicine
Stand Up To Cancer
Lustgarten Foundation
Information provided by (Responsible Party):
Sapna Syngal, Dana-Farber Cancer Institute

Brief Summary:

The goal of the GENERATE study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients with identified 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 saliva samples in 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.


Condition or disease Intervention/treatment Phase
Candidates for Hereditary Pancreatic Cancer Testing Other: Doxy.me genetic education +/- Color Genomics genetic education Other: Color Genomics genetic education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: GENetic Education Risk Assessment and TEsting Study (GENERATE)
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
Experimental: 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, 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

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.


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




Primary Outcome Measures :
  1. Change of genetic testing among relatives of pancreatic cancer patients with mutations [ Time Frame: 2 years ]
    Measure the effect that alternative methods of offering genetic education have on the increase of genetic testing among first and second-degree relatives of mutation positive pancreatic cancer 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.


Secondary Outcome Measures :
  1. Level of cancer-risk distress [ Time Frame: Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention ]
    Measure the degree that individuals worry about getting cancer using the adapted Lerman Breast Cancer Worry Scale. This is an 8 item scale with a total score ranging from 8-32, with high scores indicating more frequent worries. A cut-off of equal to or greater than 14 will indicate moderate to high cancer worry.

  2. Increase of knowledge of genetic testing [ Time Frame: Immediately post intervention ]
    Assess the participants' understanding of general concepts learned within a genetic counseling session targeted towards multigene panel testing, including inheritance, inherited cancer risks, possible test results of multi-gene panel testing and limitations, and changes in medical management related to an inherited cancer risk

  3. Factors in decision making [ Time Frame: Immediately post intervention ]
    Assess the participants perception of how helpful the genetic education was in deciding to pursue genetic testing using a validated 10 item Preparation for Decision Making Scale. This is a brief validated 10 item measure that assesses the participants perception of how useful a decision support intervention is in preparing the participant to make a health decision. Items are summed and scored, and higher scores indicate higher perceived level of preparation.

  4. Degree of family communication about genetic test results [ Time Frame: 3-4 months post intervention, 15 months post intervention ]
    Measure items pertaining to disclosure of genetic test results to relatives which includes asking if participants communicated at all with specific family members and if they disclosed results of genetic testing to anyone in their family

  5. Uptake of surveillance for pancreatic, other associated cancers and health behaviors [ Time Frame: Baseline and 15 months post intervention ]
    Examine appropriate screening (such as mammography, colonoscopy) uptake and health behaviors (i.e. smoking, alcohol use) for those who test positive or negative in both arms of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individual who is 18 years or older
  • Individual who has signed the informed consent
  • Individual who has been informed about:

    • A first or second-degree relative with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and a germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53, OR
    • An unaffected first or second-degree relative with a germline mutation in one of these genes who is a first or second-degree relative to a PDAC case
  • The germline mutation and history of PDAC must both 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 with a known cancer susceptibility gene
  • Individual who has received prior genetic counseling for cancer risk
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762590


Contacts
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Contact: Sapna Syngal, MD, MPH 617-632-6164 SSYNGAL@PARTNERS.ORG

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sapna Syngal, MD, MPH    617-632-6164    SSYNGAL@PARTNERS.ORG   
Principal Investigator: Sapna Syngal, MD, MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
M.D. Anderson Cancer Center
Johns Hopkins University
University of California, San Diego
Mayo Clinic
Weill Cornell Medicine
Stand Up To Cancer
Lustgarten Foundation
Investigators
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Principal Investigator: Sapna Syngal, MD, MPH Dana-Farber Cancer Institute

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Responsible Party: Sapna Syngal, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03762590     History of Changes
Other Study ID Numbers: 18-222
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sapna Syngal, Dana-Farber Cancer Institute:
Candidates for Hereditary Pancreatic Cancer Testing
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents