<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762590</url>
  </required_header>
  <id_info>
    <org_study_id>18-222</org_study_id>
    <nct_id>NCT03762590</nct_id>
  </id_info>
  <brief_title>GENetic Education Risk Assessment and TEsting Study</brief_title>
  <acronym>GENERATE</acronym>
  <official_title>GENetic Education Risk Assessment and TEsting Study (GENERATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stand Up To Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lustgarten Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family&#xD;
      members of pancreatic cancer patients who may have genetic mutations (inherited changes). The&#xD;
      study will measure how different methods of genetic education increase the rate of genetic&#xD;
      testing in these families.&#xD;
&#xD;
      This is an investigational study to measure the effects of two methods of genetic education.&#xD;
      Participants may elect to undergo genetic testing as part of the study and will be asked to&#xD;
      provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is&#xD;
      FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA)&#xD;
      certified laboratory.&#xD;
&#xD;
      Up to 1,000 participants will be enrolled in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Around 1 in 10 (10%) pancreatic cancer patients carries an inherited change (mutation) in a&#xD;
      gene which can increase the risk of cancer. Relatives of patients with pancreatic cancer are&#xD;
      often unaware that the mutation can be passed down through the family. Having information&#xD;
      about genetic risk can be important to family members. There may be options for early and/or&#xD;
      more frequent screening (to look for cancer or pre-cancer) or early detection&#xD;
      recommendations.&#xD;
&#xD;
      This research is being done to study the impact of different methods of teaching about and&#xD;
      offering genetic testing to family members of pancreatic cancer patients who may carry a&#xD;
      mutation.&#xD;
&#xD;
      Study arms:&#xD;
&#xD;
      Individuals will be randomized (like flipping a coin) by family to one of the two study arms&#xD;
      to receive genetic education and elect to undergo genetic testing.&#xD;
&#xD;
      Individuals in Arm 1 (video conference platform plus Color Genomics) will receive genetic&#xD;
      education via a pre-recorded educational video and interactive session with the study team&#xD;
      through an internet-based platform.&#xD;
&#xD;
      Individuals in Arm 2 (Color Genomics Only) will receive genetic education from Color&#xD;
      Genomics, Inc., an online, commercial genetic testing service.&#xD;
&#xD;
      Informed consent:&#xD;
&#xD;
      Participants will be asked to provide informed consent in order to join the study.&#xD;
&#xD;
      Study questionnaires:&#xD;
&#xD;
      Questionnaires will be given at baseline and throughout the duration of the study.&#xD;
      Participants will be asked to complete questionnaires through the online study database,&#xD;
      called REDCap (paper questionnaires are also an option). The baseline questionnaires will ask&#xD;
      participants about their medical history, their experience with pancreatic cancer and other&#xD;
      relevant health behaviors.&#xD;
&#xD;
      The follow-up questionnaires will ask about how much participants worried about cancer, how&#xD;
      participants made choices, their knowledge gained and how much families shared genetic test&#xD;
      results (if participants chose to get testing). The study will also ask about participants'&#xD;
      choices to have pancreas exams and other surveillance (long-term screening) procedures, and&#xD;
      their lifestyle choices after receiving the intervention.&#xD;
&#xD;
      Genetic testing:&#xD;
&#xD;
      GENERATE offers genetic testing at no cost to participants in the study. Color Genomics will&#xD;
      provide the genetic testing services for the study. Participants will be directed to create a&#xD;
      personal Color Genomics account that will allow them to enter their personal and family&#xD;
      history information, keep track of their genetic testing kit and receive their genetic test&#xD;
      results. Participants will be mailed an FDA-approved saliva collection kit from Color&#xD;
      Genomics. When participants receive the kit in the mail, they will be able to use the kit's&#xD;
      unique barcode number to activate it and link it to their online account. A video on the&#xD;
      website will show participants how to provide a large enough saliva sample. It will also&#xD;
      contain instructions for how to properly package and mail back the kit to Color Genomics&#xD;
      using a pre-paid shipping package.&#xD;
&#xD;
      Getting test results:&#xD;
&#xD;
      It usually takes about 4-6 weeks to get the results back from this genetic test. Participants&#xD;
      will receive an email letting them know that their results are available for review through&#xD;
      their Color Genomics account or via a phone call with a Color Genomics genetic counselor.&#xD;
&#xD;
      Length of study:&#xD;
&#xD;
      The total participation on this study will last about 18 months, including follow-up.&#xD;
      Participants may be contacted regarding participation in future studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 8, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of cancer-risk distress</measure>
    <time_frame>Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase of knowledge of genetic testing</measure>
    <time_frame>Immediately post intervention</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors in decision making</measure>
    <time_frame>Immediately post intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of family communication about genetic test results</measure>
    <time_frame>3-4 months post intervention, 15 months post intervention</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of surveillance for pancreatic, other associated cancers and health behaviors</measure>
    <time_frame>Baseline and 15 months post intervention</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Candidates for Hereditary Pancreatic Cancer Testing</condition>
  <arm_group>
    <arm_group_label>Doxy.me plus Color Genomics Arm (Arm 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive genetic education through an online platform called Doxy.me&#xD;
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&#xD;
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&#xD;
Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Color Genomics Only Arm (Arm 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video&#xD;
After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing&#xD;
Intervention is genetic education via Color Genomics website</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Doxy.me genetic education +/- Color Genomics genetic education</intervention_name>
    <description>Doxy.me is a HIPAA compliant telemedicine platform that allows clinicians to provide education to remote patients.&#xD;
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.&#xD;
Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.</description>
    <arm_group_label>Doxy.me plus Color Genomics Arm (Arm 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Color Genomics genetic education</intervention_name>
    <description>Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.</description>
    <arm_group_label>Color Genomics Only Arm (Arm 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual who is 18 years or older&#xD;
&#xD;
          -  Individual who has signed the informed consent&#xD;
&#xD;
          -  Individual with:&#xD;
&#xD;
             --A first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR&#xD;
             a second-degree relative who has (or had) PDAC and has a known germline mutation in&#xD;
             APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53&#xD;
&#xD;
          -  The germline mutation and history of PDAC must be on the maternal side or paternal&#xD;
             side of the individual's family&#xD;
&#xD;
          -  Individual with a valid United States mailing address&#xD;
&#xD;
          -  Individual with access to a healthcare provider and is willing to share genetic test&#xD;
             results with that provider/the study team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual with a known cancer susceptibility gene&#xD;
&#xD;
          -  Individual who has received genetic counseling for cancer risk within the last 3 years&#xD;
&#xD;
          -  Individual who has received a bone marrow transplant, who has had a blood transfusion&#xD;
             within the last 7 days, or who has an active hematologic malignancy (i.e. leukemia or&#xD;
             lymphoma)&#xD;
&#xD;
          -  Individual who is unable to sign the informed consent because of mental incompetency&#xD;
             or psychiatric illness&#xD;
&#xD;
          -  Individual who is unwilling to complete baseline and follow-up questionnaires&#xD;
&#xD;
          -  Individual who has a life expectancy of less than 1 year&#xD;
&#xD;
          -  Individual with only APC I1307K mutation within their family&#xD;
&#xD;
          -  Individual with only PMS2 exons 12-15 deletion mutation within their family&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sapna Syngal, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Sapna Syngal, MF, MPH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Candidates for Hereditary Pancreatic Cancer Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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. 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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762590
org study id: 18-222
nct id: NCT03762590
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Around 1 in 10 (10%) pancreatic cancer patients carries an inherited change (mutation) in a
      gene which can increase the risk of cancer. Relatives of patients with pancreatic cancer are
      often unaware that the mutation can be passed down through the family. Having information
      about genetic risk can be important to family members. There may be options for early and/or
      more frequent screening (to look for cancer or pre-cancer) or early detection
      recommendations.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: 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
time frame: 2 years
description: 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.
measure: Level of cancer-risk distress
time frame: Baseline, immediately post intervention, 3-4 months post intervention, 15 months post intervention
description: 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.
measure: Increase of knowledge of genetic testing
time frame: Immediately post intervention
description: 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
measure: Factors in decision making
time frame: Immediately post intervention
description: 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.
measure: Degree of family communication about genetic test results
time frame: 3-4 months post intervention, 15 months post intervention
description: 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
measure: Uptake of surveillance for pancreatic, other associated cancers and health behaviors
time frame: Baseline and 15 months post intervention
description: 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
arm group label: Doxy.me plus Color Genomics Arm (Arm 1)
arm group type: Experimental
description: 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
arm group label: Color Genomics Only Arm (Arm 2)
arm group type: Experimental
description: 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
intervention type: Other
intervention name: Doxy.me genetic education +/- Color Genomics genetic education
description: 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.
arm group label: Doxy.me plus Color Genomics Arm (Arm 1)
intervention type: Other
intervention name: Color Genomics genetic education
description: Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.
arm group label: Color Genomics Only Arm (Arm 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sapna Syngal, MD, MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Sapna Syngal, MF, MPH
investigator title: Principal Investigator
mesh term: Pancreatic Neoplasms
sharing ipd: No
ipd 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. 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.