<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/NCT04460417</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-1573</org_study_id>
    <nct_id>NCT04460417</nct_id>
  </id_info>
  <brief_title>Chicago Community Health Study</brief_title>
  <acronym>CCHS</acronym>
  <official_title>Health Behavior and Feedback Among Chicago Area Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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 study examined smokers from the initial COMPASS survey who live in one of three local&#xD;
      Census tracks with large concentrations of minority populations and smoking rates, including&#xD;
      Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7%&#xD;
      smoker), and Bridgeport (34.5% Asian, 27.0% Hispanic, 29.3% smoker), randomizing them to&#xD;
      receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute)&#xD;
      versus theoretically-driven and empirically-supported smoking cessation advice session&#xD;
      delivered in-person at the UCM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking reduction</measure>
    <time_frame>Past-week CPD at 1- and 6-month follow-up</time_frame>
    <description>Change in average cigarettes per day (CPD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up</time_frame>
    <description>Change in number of any and serious (12+hr) quit attempts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivation to change smoking</measure>
    <time_frame>Increases in stage of change at 1- and 6-month follow-ups</time_frame>
    <description>Increase in motivation to change smoking behavior via smoking contemplation ladder (Biener-Abrams Contemplation Ladder) scores. Scores are on a 10-point scale from 0-10, with higher scores indicating higher motivation to quit smoking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine Replacement Therapy (NRT) use</measure>
    <time_frame>Any reported NRT use since last session at 1- and 6- month follow-up</time_frame>
    <description>Change in frequency of NRT use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine Replacement Therapy (NRT) knowledge</measure>
    <time_frame>More accurate knowledge about NRT at 1- and 6-month follow-ups</time_frame>
    <description>Increase in accurate knowledge about NRT assessed by two items rated from a 1 (strongly disagree) to 7 (strongly agree) scale measuring agreement to the NRT myths, &quot;NRT causes cancer&quot; and &quot;NRT is only used by weak people&quot;.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Enhanced care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in an approximate one-hour health and smoking feedback session at the University of Chicago in Dr. King's Clinical Addictions Research Laboratory (CARL). The session will follow the Courage to Quit™ (CTQ) Roadmap program (developed by Dr. King with the Respiratory Health Association). This roadmap shorter version of the larger CTQ program has been specifically designed as an inpatient bedside or outpatient brief intervention guide to assess smoking cessation motivation, consequences of smoking, facts and myths about smoking, barriers to making a change, approved medications, de-bunking myths about medications or treatments without scientific evidence (e-cigarette, laser treatments, herbals, etc.), and gaining social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the National Cancer Institute (NCI) pamphlet &quot;Clearing the Air&quot; and access to related online resources, which includes brief advice to quit smoking and medication information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Care</intervention_name>
    <description>The session began with the therapist reviewing the participants' personal feedback sheet within the context of clear messaging that there is no safe level of smoking and of how smoking affects the participant individually and the Black community collectively. The participant was encouraged to quit smoking, else to reduce smoking if abstinence was not desired, and to use NRT within the next week to help foster behavior change and alleviate withdrawal symptoms. This portion of the counseling was presented within a culturally-targeted framework such that myths regarding NRT common among persons with low health literacy were discussed and debunked and historical mistrust of the medical community and concerns about exploitation were also addressed. Each participant in EC was offered a starter kit of NRT with a one week supply of patches or lozenges.</description>
    <arm_group_label>Enhanced care</arm_group_label>
    <other_name>EC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>Participants met with a research assistant for 3-5 minutes and received the National Cancer Institute (NCI) pamphlet &quot;Clearing the Air&quot; and access to related online resources, which includes brief advice to quit smoking and medication information. They did not receive counseling or specialized care and were advised to refer to the resources should they be interested in quitting smoking.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently reside in either the Washington Park, Gage Park, or Bridgeport communities&#xD;
             based on current physical address at the time of initial contact for study&#xD;
             participation&#xD;
&#xD;
          -  Identify as a current smoker (verified by self-report and exhaled carbon monoxide)&#xD;
&#xD;
          -  Willing and able to sign an informed consent&#xD;
&#xD;
          -  Stable residence and contact information throughout the follow-up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a current smoker&#xD;
&#xD;
          -  Does not live within the pre-determined neighborhood locations&#xD;
&#xD;
          -  Unable to sign informed consent&#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>Andrea King, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</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/NCT04460417
org study id: IRB16-1573
nct id: NCT04460417
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study examined smokers from the initial COMPASS survey who live in one of three local
      Census tracks with large concentrations of minority populations and smoking rates, including
      Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7%
      smoker), and Bridgeport (34.5% Asian, 27.0% Hispanic, 29.3% smoker), randomizing them to
      receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute)
      versus theoretically-driven and empirically-supported smoking cessation advice session
      delivered in-person at the UCM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking reduction
time frame: Past-week CPD at 1- and 6-month follow-up
description: Change in average cigarettes per day (CPD)
measure: Quit attempts
time frame: Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
description: Change in number of any and serious (12+hr) quit attempts
measure: Motivation to change smoking
time frame: Increases in stage of change at 1- and 6-month follow-ups
description: Increase in motivation to change smoking behavior via smoking contemplation ladder (Biener-Abrams Contemplation Ladder) scores. Scores are on a 10-point scale from 0-10, with higher scores indicating higher motivation to quit smoking.
measure: Nicotine Replacement Therapy (NRT) use
time frame: Any reported NRT use since last session at 1- and 6- month follow-up
description: Change in frequency of NRT use
measure: Nicotine Replacement Therapy (NRT) knowledge
time frame: More accurate knowledge about NRT at 1- and 6-month follow-ups
description: Increase in accurate knowledge about NRT assessed by two items rated from a 1 (strongly disagree) to 7 (strongly agree) scale measuring agreement to the NRT myths, "NRT causes cancer" and "NRT is only used by weak people".
arm group label: Enhanced care
arm group type: Experimental
description: Participants will take part in an approximate one-hour health and smoking feedback session at the University of Chicago in Dr. King's Clinical Addictions Research Laboratory (CARL). The session will follow the Courage to Quit™ (CTQ) Roadmap program (developed by Dr. King with the Respiratory Health Association). This roadmap shorter version of the larger CTQ program has been specifically designed as an inpatient bedside or outpatient brief intervention guide to assess smoking cessation motivation, consequences of smoking, facts and myths about smoking, barriers to making a change, approved medications, de-bunking myths about medications or treatments without scientific evidence (e-cigarette, laser treatments, herbals, etc.), and gaining social support.
arm group label: Treatment as Usual
arm group type: Active Comparator
description: Participants will receive the National Cancer Institute (NCI) pamphlet "Clearing the Air" and access to related online resources, which includes brief advice to quit smoking and medication information.
intervention type: Behavioral
intervention name: Enhanced Care
description: The session began with the therapist reviewing the participants' personal feedback sheet within the context of clear messaging that there is no safe level of smoking and of how smoking affects the participant individually and the Black community collectively. The participant was encouraged to quit smoking, else to reduce smoking if abstinence was not desired, and to use NRT within the next week to help foster behavior change and alleviate withdrawal symptoms. This portion of the counseling was presented within a culturally-targeted framework such that myths regarding NRT common among persons with low health literacy were discussed and debunked and historical mistrust of the medical community and concerns about exploitation were also addressed. Each participant in EC was offered a starter kit of NRT with a one week supply of patches or lozenges.
arm group label: Enhanced care
other name: EC
intervention type: Behavioral
intervention name: TAU
description: Participants met with a research assistant for 3-5 minutes and received the National Cancer Institute (NCI) pamphlet "Clearing the Air" and access to related online resources, which includes brief advice to quit smoking and medication information. They did not receive counseling or specialized care and were advised to refer to the resources should they be interested in quitting smoking.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea King, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No