<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/NCT03038542</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00044521</org_study_id>
    <nct_id>NCT03038542</nct_id>
  </id_info>
  <brief_title>Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages</brief_title>
  <official_title>Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</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>
      This study evaluates a text messaging intervention through a smokers' quitline. Smokers will&#xD;
      either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored,&#xD;
      standard care text messages, both combined with standard quitline treatment. We hypothesize&#xD;
      that the gain-framed text message intervention will increase cessation rates at 30 weeks as&#xD;
      compared to standard care text messages.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survey of smoking status</measure>
    <time_frame>Week 30</time_frame>
    <description>smoking or abstinent</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Treatment Text Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Text Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gain-framed text messages</intervention_name>
    <arm_group_label>Treatment Text Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard care text messages</intervention_name>
    <arm_group_label>Standard Text Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) call the Quitline requesting assistance with quitting smoking, 2) be 18+ years old,&#xD;
             3) speak English, 4) have a verified New York address, and 5) opt into the standard&#xD;
             Quitline texting protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Benjamin Toll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03038542
org study id: Pro00044521
nct id: NCT03038542
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates a text messaging intervention through a smokers' quitline. Smokers will
      either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored,
      standard care text messages, both combined with standard quitline treatment. We hypothesize
      that the gain-framed text message intervention will increase cessation rates at 30 weeks as
      compared to standard care text messages.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: survey of smoking status
time frame: Week 30
description: smoking or abstinent
arm group label: Treatment Text Arm
arm group type: Experimental
arm group label: Standard Text Arm
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Gain-framed text messages
arm group label: Treatment Text Arm
intervention type: Behavioral
intervention name: Standard care text messages
arm group label: Standard Text Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin Toll, PhD
role: Principal Investigator
affiliation: Medical University of South Carolina
responsible party type: Sponsor