<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/NCT04455698</url>
  </required_header>
  <id_info>
    <org_study_id>CIRB21-0176</org_study_id>
    <nct_id>NCT04455698</nct_id>
  </id_info>
  <brief_title>Engaging and Activating Cancer Survivors in Genetic Services Study</brief_title>
  <acronym>ENGAGE</acronym>
  <official_title>Engaging and Activating Cancer Survivors in Genetic Services Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To address the gap in access to genetic services, this study will evaluate the effectiveness&#xD;
      of an adapted model of remote delivery of genetic services to increase the uptake of&#xD;
      recommended genetic assessment and testing in childhood cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As childhood cancer survivors receive care locally from PCPs, the in-home, collaborative PCP&#xD;
      model is designed to increase access to genetic services and uptake of genetic testing in&#xD;
      childhood cancer survivors. In this model, individual survivors can access remote telegenetic&#xD;
      services and genetic counselors will partner with PCPs to order genetic testing.&#xD;
&#xD;
      This study comprises of a 3-arm randomized Hybrid 1 Effectiveness and Implementation study in&#xD;
      360 CCSS survivors to evaluate the effectiveness of our in-home, collaborative PCP model of&#xD;
      remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer&#xD;
      survivors compared to usual care options for genetic testing.&#xD;
&#xD;
      Aims are as follows:&#xD;
&#xD;
      To evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic&#xD;
      services to increase uptake of genetic testing at 6 months as compared to usual care among&#xD;
      childhood cancer survivors who meet criteria for cancer genetic testing. Our primary outcome&#xD;
      will be a composite variable indicating whether a person had pre-test counseling or genetic&#xD;
      testing.&#xD;
&#xD;
      To evaluate the effectiveness of remote videoconferencing to provide greater increase in&#xD;
      knowledge and decrease in distress and depression as compared to remote phone services, to&#xD;
      examine the moderators of patient outcomes with remote telegenetic services, and to estimate&#xD;
      intervention costs and incremental cost-effectiveness of the three study arms.&#xD;
&#xD;
      To conduct a multi-stakeholder, mixed-methods process evaluation to understand patient,&#xD;
      provider and system factors associated with uptake of counseling and testing in our adapted&#xD;
      in-home, collaborative PCP model and facilitators and barriers to uptake to provide&#xD;
      recommendations for future implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 16, 2021</start_date>
  <completion_date type="Anticipated">September 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</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>Number of participants who received testing or genetic counseling</measure>
    <time_frame>6 Months status survey (ARM C)</time_frame>
    <description>Primary composite outcome collected via remote services records-Yes/No (ARMS A/B)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic Knowledge Scale</measure>
    <time_frame>Baseline - Within 7 Days After Result Disclosure</time_frame>
    <description>Change in knowledge (ARMS A/B only). Increased change score indicates increase in knowledge (better).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Events Scale (IES)</measure>
    <time_frame>Baseline - Within 7 Days After Result Disclosure</time_frame>
    <description>Change in Cancer Specific Distress (ARMS A/B only). Score Range = 0-40. Decreased score change indicates a decrease in distress (better).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS)</measure>
    <time_frame>Baseline - Within 7 Days After Result Disclosure</time_frame>
    <description>Change in Depression (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in depression (better).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uptake of genetic counseling, testing, and identification of genetic carriers</measure>
    <time_frame>6 month status survey (ARM C)</time_frame>
    <description>Collected via remote services records (ARMS A/B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measurement Information Systems (PROMIS)</measure>
    <time_frame>Baseline - Within 7 Days After Result Disclosure</time_frame>
    <description>Change in Anxiety (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)</measure>
    <time_frame>Baseline - Within 7 Days After Result Disclosure</time_frame>
    <description>Change in Uncertainty (ARMS A/B only). Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement)</measure>
    <time_frame>Baseline - 6 Months After Result Disclosure</time_frame>
    <description>Change in performance of risk reductive and screening behaviors and communication of results - Yes/No responses (ARMS A/B only).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Remote Telegenetics: TELEPHONE (ARM A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remote Phone Telegenetics:&#xD;
Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote Telegenetics: VIDEOCONFERENCING (ARM B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remote Videoconferencing Telegenetics:&#xD;
Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - VIDEOCONFERENCING.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USUAL CARE (ARM C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual Care:&#xD;
Participants will receive referrals to genetic counseling providers, initiating services on their own. At 6 months, if participants have not sought and received genetic counseling services, they will be offered randomization to ARM A/ARM B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Remote Telegenetic Counseling by Phone</intervention_name>
    <description>Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.</description>
    <arm_group_label>Remote Telegenetics: TELEPHONE (ARM A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Remote Telegenetic Counseling by Videoconferencing</intervention_name>
    <description>Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.</description>
    <arm_group_label>Remote Telegenetics: VIDEOCONFERENCING (ARM B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Arm</intervention_name>
    <description>Participants in the usual care arm will receive usual care services depending on which referral method they choose and if they initiate services. After a 6 month status survey, if they have not had genetic services through usual care they will be offered services and re-randomized to ARM A/ARM B.</description>
    <arm_group_label>USUAL CARE (ARM C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and communicate in English or Spanish&#xD;
&#xD;
          -  Currently residing in the US&#xD;
&#xD;
          -  Childhood Cancer Survivor Study Participant survivors of the following primary&#xD;
             cancers:&#xD;
&#xD;
               -  CNS tumor&#xD;
&#xD;
               -  Sarcoma (except Ewing sarcoma)&#xD;
&#xD;
               -  Hepatoblastoma&#xD;
&#xD;
               -  Leukemia&#xD;
&#xD;
          -  Childhood Cancer Survivor Study Participant with a family history of a child with&#xD;
             cancer:&#xD;
&#xD;
               -  2 or more malignancies in childhood (age 18 or younger)&#xD;
&#xD;
               -  A first degree relative (parent or sibling) with cancer aged 45 or younger&#xD;
&#xD;
               -  2 or more second degree relatives with cancer aged 45 or younger (same side of&#xD;
                  family)&#xD;
&#xD;
               -  Parents of the child with cancer are related (consanguinity)&#xD;
&#xD;
               -  Other family history that meets NCCN criteria&#xD;
&#xD;
          -  Able to communicate remotely through remote telegenetic platforms (phone or&#xD;
             videoconference) with genetic counselors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncorrected or uncompensated speech defects that would lead to the participant being&#xD;
             unable to communicate effectively with genetic counselor&#xD;
&#xD;
          -  Currently residing in a US state or territory where genetic counselors are not&#xD;
             licensed to provide care&#xD;
&#xD;
          -  Uncontrolled psychiatric/mental condition or severe physical, neurological or&#xD;
             cognitive deficits rendering individual unable to understand study goals and task&#xD;
&#xD;
          -  Participants who have already completed and received a clinically appropriate&#xD;
             multi-gene panel genetic testing&#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>Tara O Henderson, MD, MPH, FASCO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Bradbury, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tara Henderson, MD</last_name>
    <phone>7737026808</phone>
    <email>thenderson@peds.bsd.uchicago.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Becky Puplava</last_name>
    <email>rpuplava@peds.bsd.uchicago.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tara Henderson, MD</last_name>
      <phone>773-702-6808</phone>
      <email>thenderson@peds.bsd.uchicago.edu</email>
    </contact>
    <contact_backup>
      <last_name>Melissa Marx, MPH</last_name>
      <phone>(773)702-2927</phone>
      <email>mailto:mmarx@peds.bsd.uchicago.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Tara Henderson, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Bradbury, MD</last_name>
      <phone>800-789-7366</phone>
      <email>angela.bradbury@pennmedicine.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Beth Wood</last_name>
      <phone>215-662-4303</phone>
      <email>elisabeth.wood@pennmedicine.upenn.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Angela Bradbury, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-3678</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaron McDonald, PhD</last_name>
      <phone>901-595-6177</phone>
      <email>aaron.mcdonald@stjude.org</email>
    </contact>
    <contact_backup>
      <last_name>Margaret King, PhD</last_name>
      <phone>901-595-8453</phone>
      <email>Margaret.King@stjude.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04455698
org study id: CIRB21-0176
nct id: NCT04455698
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To address the gap in access to genetic services, this study will evaluate the effectiveness
      of an adapted model of remote delivery of genetic services to increase the uptake of
      recommended genetic assessment and testing in childhood cancer survivors.
As childhood cancer survivors receive care locally from PCPs, the in-home, collaborative PCP
      model is designed to increase access to genetic services and uptake of genetic testing in
      childhood cancer survivors. In this model, individual survivors can access remote telegenetic
      services and genetic counselors will partner with PCPs to order genetic testing.

      This study comprises of a 3-arm randomized Hybrid 1 Effectiveness and Implementation study in
      360 CCSS survivors to evaluate the effectiveness of our in-home, collaborative PCP model of
      remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer
      survivors compared to usual care options for genetic testing.

      Aims are as follows:

      To evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic
      services to increase uptake of genetic testing at 6 months as compared to usual care among
      childhood cancer survivors who meet criteria for cancer genetic testing. Our primary outcome
      will be a composite variable indicating whether a person had pre-test counseling or genetic
      testing.

      To evaluate the effectiveness of remote videoconferencing to provide greater increase in
      knowledge and decrease in distress and depression as compared to remote phone services, to
      examine the moderators of patient outcomes with remote telegenetic services, and to estimate
      intervention costs and incremental cost-effectiveness of the three study arms.

      To conduct a multi-stakeholder, mixed-methods process evaluation to understand patient,
      provider and system factors associated with uptake of counseling and testing in our adapted
      in-home, collaborative PCP model and facilitators and barriers to uptake to provide
      recommendations for future implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of participants who received testing or genetic counseling
time frame: 6 Months status survey (ARM C)
description: Primary composite outcome collected via remote services records-Yes/No (ARMS A/B)
measure: Genetic Knowledge Scale
time frame: Baseline - Within 7 Days After Result Disclosure
description: Change in knowledge (ARMS A/B only). Increased change score indicates increase in knowledge (better).
measure: Impact of Events Scale (IES)
time frame: Baseline - Within 7 Days After Result Disclosure
description: Change in Cancer Specific Distress (ARMS A/B only). Score Range = 0-40. Decreased score change indicates a decrease in distress (better).
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
time frame: Baseline - Within 7 Days After Result Disclosure
description: Change in Depression (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in depression (better).
measure: Uptake of genetic counseling, testing, and identification of genetic carriers
time frame: 6 month status survey (ARM C)
description: Collected via remote services records (ARMS A/B)
measure: Patient Reported Outcomes Measurement Information Systems (PROMIS)
time frame: Baseline - Within 7 Days After Result Disclosure
description: Change in Anxiety (ARMS A/B only). Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).
measure: Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)
time frame: Baseline - Within 7 Days After Result Disclosure
description: Change in Uncertainty (ARMS A/B only). Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).
measure: Change in Health Behaviors (Selected from the Behavioral Risk Factor Surveillance System Questionnaire and the Health and Diet survey Dietary Guidelines Supplement)
time frame: Baseline - 6 Months After Result Disclosure
description: Change in performance of risk reductive and screening behaviors and communication of results - Yes/No responses (ARMS A/B only).
arm group label: Remote Telegenetics: TELEPHONE (ARM A)
arm group type: Experimental
description: Remote Phone Telegenetics:
Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - TELEPHONE.
arm group label: Remote Telegenetics: VIDEOCONFERENCING (ARM B)
arm group type: Experimental
description: Remote Videoconferencing Telegenetics:
Participants with complete pre-test and disclosure counseling with a Genetic Counselor using remote services - VIDEOCONFERENCING.
arm group label: USUAL CARE (ARM C)
arm group type: Experimental
description: Usual Care:
Participants will receive referrals to genetic counseling providers, initiating services on their own. At 6 months, if participants have not sought and received genetic counseling services, they will be offered randomization to ARM A/ARM B.
intervention type: Behavioral
intervention name: Remote Telegenetic Counseling by Phone
description: Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
arm group label: Remote Telegenetics: TELEPHONE (ARM A)
intervention type: Behavioral
intervention name: Remote Telegenetic Counseling by Videoconferencing
description: Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
arm group label: Remote Telegenetics: VIDEOCONFERENCING (ARM B)
intervention type: Behavioral
intervention name: Usual Care Arm
description: Participants in the usual care arm will receive usual care services depending on which referral method they choose and if they initiate services. After a 6 month status survey, if they have not had genetic services through usual care they will be offered services and re-randomized to ARM A/ARM B.
arm group label: USUAL CARE (ARM C)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tara O Henderson, MD, MPH, FASCO
role: Principal Investigator
affiliation: University of Chicago
last name: Angela Bradbury, MD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Tara Henderson, MD
phone: 7737026808
email: thenderson@peds.bsd.uchicago.edu
last name: Becky Puplava
email: rpuplava@peds.bsd.uchicago.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
sharing ipd: No