<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/NCT03247634</url>
  </required_header>
  <id_info>
    <org_study_id>CASE11Z17</org_study_id>
    <nct_id>NCT03247634</nct_id>
  </id_info>
  <brief_title>Getting Ahead for Cancer Control</brief_title>
  <official_title>Getting Ahead for Cancer Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>
      A new, practical program, entitled Getting Ahead in a Just-Gettin'-By World, provides a novel&#xD;
      approach to addressing this previously intractable problem. During the progression through&#xD;
      the Getting Ahead program, individuals develop an understanding of the hidden rules of&#xD;
      economic class and have an opportunity to craft a hopeful future story based on the practical&#xD;
      concepts investigated in the modules. Getting Ahead has shown great success in various&#xD;
      organizations and communities in multiple sectors, including healthcare, but has not been&#xD;
      studied in the context of advancing cancer prevention and control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team hypothesizes that the Getting Ahead program, applied in safety net practices&#xD;
      with primary care patients living in poverty, will improve cancer prevention and early&#xD;
      detection activities, mediated by a shift in future orientation gained through the program.&#xD;
&#xD;
      This pilot study aims to adapt, apply, and evaluate the established Getting Ahead program in&#xD;
      a health care setting and assess its effect on cancer prevention and early detection&#xD;
      activities for vulnerable populations. By generating process and outcome data on a novel&#xD;
      intervention to help people advance out of poverty, this research will set the stage for&#xD;
      larger intervention studies, and also will advance understanding of the mechanisms by which&#xD;
      growing a future orientation can improve cancer preventive service delivery among vulnerable&#xD;
      populations.&#xD;
&#xD;
      Specifically, this study aims to:&#xD;
&#xD;
        1. Implement Getting Ahead among cohorts of patients at a network of safety net practices.&#xD;
&#xD;
        2. Assess the paradigm shift in developing a future orientation associated with&#xD;
           participation in the Getting Ahead program.&#xD;
&#xD;
        3. Evaluate the effect of the Getting Ahead program and its associated paradigm shift on&#xD;
           graduates' cancer prevention and early detection activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Interrupted Time Series - All cohorts will receive the Getting Ahead program</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in composite score of cancer prevention</measure>
    <time_frame>From baseline up to 3 years</time_frame>
    <description>Change in composite score of cancer prevention based on changes in cognition, intention and behavior regarding tobacco reduction, fruit and vegetable consumption, and physical activity; Immunizations for human papillomavirus (HPV) or hepatitis B; Age/sex appropriate use of Pap tests, mammograms, stool tests, endoscopy or imaging studies for colorectal cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in composite score of progress toward a future orientation</measure>
    <time_frame>From baseline up to 3 years</time_frame>
    <description>change in composite scores based on 11 resource areas with a score ranging from 1-5 (total scores ranging from 11-55 with 55 being the most stable score). The score indicates the level of stability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>Getting Ahead Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 staggered cohorts will be given the Getting Ahead program, using the established Getting Ahead in a Just-Gettin'-By World program. Six practices will be used. Each participant will come in for 16 session over an eight week period and will be followed up six months post intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Getting Ahead in a Just-Gettin'-By World</intervention_name>
    <description>The Getting Ahead program is a unique welldeveloped program that allows carefully guided introspection toward the crafting of tailored solutions aimed at addressing complex social determinants of health among individuals living in vulnerable populations where the achievement of health equity often seems unattainable. The important lens of health equity is a key component of this proposal and is consistent with the American Cancer Society overarching emphasis on reduction of health disparities and achievement of health equity.</description>
    <arm_group_label>Getting Ahead Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Interest and willingness to commit to the 8 week Getting Ahead training program that&#xD;
             will occur over 16 sessions occurring twice a week&#xD;
&#xD;
          -  Willingness to commit to follow-up with his/her primary care provider after completion&#xD;
             of the Getting Ahead training program&#xD;
&#xD;
          -  Willingness to be randomized to an immediate or delayed (by 8 weeks) start date&#xD;
&#xD;
          -  Ability to speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi Gullett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heidi Gullett, MD</last_name>
    <phone>216-368-0776</phone>
    <email>heidi.gullett@case.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heidi Gullett, MD</last_name>
      <phone>216-368-0776</phone>
      <email>heidi.gullett@case.edu</email>
    </contact>
    <investigator>
      <last_name>Heidi Gullett, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>getting ahead</keyword>
  <keyword>vulnerable population</keyword>
  <keyword>safety net practice network</keyword>
  <!-- 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/NCT03247634
org study id: CASE11Z17
nct id: NCT03247634
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A new, practical program, entitled Getting Ahead in a Just-Gettin'-By World, provides a novel
      approach to addressing this previously intractable problem. During the progression through
      the Getting Ahead program, individuals develop an understanding of the hidden rules of
      economic class and have an opportunity to craft a hopeful future story based on the practical
      concepts investigated in the modules. Getting Ahead has shown great success in various
      organizations and communities in multiple sectors, including healthcare, but has not been
      studied in the context of advancing cancer prevention and control.
The study team hypothesizes that the Getting Ahead program, applied in safety net practices
      with primary care patients living in poverty, will improve cancer prevention and early
      detection activities, mediated by a shift in future orientation gained through the program.

      This pilot study aims to adapt, apply, and evaluate the established Getting Ahead program in
      a health care setting and assess its effect on cancer prevention and early detection
      activities for vulnerable populations. By generating process and outcome data on a novel
      intervention to help people advance out of poverty, this research will set the stage for
      larger intervention studies, and also will advance understanding of the mechanisms by which
      growing a future orientation can improve cancer preventive service delivery among vulnerable
      populations.

      Specifically, this study aims to:

        1. Implement Getting Ahead among cohorts of patients at a network of safety net practices.

        2. Assess the paradigm shift in developing a future orientation associated with
           participation in the Getting Ahead program.

        3. Evaluate the effect of the Getting Ahead program and its associated paradigm shift on
           graduates' cancer prevention and early detection activities.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interrupted Time Series - All cohorts will receive the Getting Ahead program
primary purpose: Prevention
masking: None (Open Label)
measure: Change in composite score of cancer prevention
time frame: From baseline up to 3 years
description: Change in composite score of cancer prevention based on changes in cognition, intention and behavior regarding tobacco reduction, fruit and vegetable consumption, and physical activity; Immunizations for human papillomavirus (HPV) or hepatitis B; Age/sex appropriate use of Pap tests, mammograms, stool tests, endoscopy or imaging studies for colorectal cancer
measure: Change in composite score of progress toward a future orientation
time frame: From baseline up to 3 years
description: change in composite scores based on 11 resource areas with a score ranging from 1-5 (total scores ranging from 11-55 with 55 being the most stable score). The score indicates the level of stability
arm group label: Getting Ahead Program
arm group type: Experimental
description: 12 staggered cohorts will be given the Getting Ahead program, using the established Getting Ahead in a Just-Gettin'-By World program. Six practices will be used. Each participant will come in for 16 session over an eight week period and will be followed up six months post intervention
intervention type: Behavioral
intervention name: Getting Ahead in a Just-Gettin'-By World
description: The Getting Ahead program is a unique welldeveloped program that allows carefully guided introspection toward the crafting of tailored solutions aimed at addressing complex social determinants of health among individuals living in vulnerable populations where the achievement of health equity often seems unattainable. The important lens of health equity is a key component of this proposal and is consistent with the American Cancer Society overarching emphasis on reduction of health disparities and achievement of health equity.
arm group label: Getting Ahead Program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heidi Gullett, MD
role: Principal Investigator
affiliation: Case Comprehensive Cancer Center
last name: Heidi Gullett, MD
phone: 216-368-0776
email: heidi.gullett@case.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor