<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/NCT04489524</url>
  </required_header>
  <id_info>
    <org_study_id>Quit Smoking</org_study_id>
    <secondary_id>U01CA114582-02S2</secondary_id>
    <nct_id>NCT04489524</nct_id>
  </id_info>
  <brief_title>Smoking Cessation in NYC</brief_title>
  <official_title>A Feasibility Study of Culturally Tailored Smoking Cessation for Chinese Smokers in New York City</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators tested the feasibility of a culturally and linguistically sensitive smoking&#xD;
      cessation program with combined counseling and pharmacological components for Chinese smokers&#xD;
      in New York City; identified factors and techniques that enhance the administration and&#xD;
      appropriateness of the intervention program; and examined the effectiveness of this program&#xD;
      on quit attempts, quit rates, and overall smoking reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2006</start_date>
  <completion_date type="Actual">April 30, 2008</completion_date>
  <primary_completion_date type="Actual">April 30, 2008</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>change in smoking behavior</measure>
    <time_frame>baseline, 1 week, 1, 3, and 6-month</time_frame>
    <description>participants were asked whether they had smoked or had a puff on a cigarette and the number of cigarettes smoked in the past 7 days at multiple assessment points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Carbon monoxide (CO) concentration</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
    <description>CO, a biomarker of smoking status, was assessed at baseline and 6-m follow up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in the stages of smoking cessation</measure>
    <time_frame>baseline, 1 week, 1, 3, and 6-month</time_frame>
    <description>According to Prochaska and DiClemente ' s Stages of Change model, the stages are: precontemplation, contemplation, preparation, action, and maintenance. It's an ordinal variable that measured at multiple assessment points</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>individualized counselor-led MI sessions and NRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention (4 individualized counselor-led MI sessions and nicotine replacement therapy [NRT]) consisted of four 60-min in-person sessions of AMI counseling and a packet of self-help smoking cessation materials. Participants were provided NRT packs and counseled on their use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general health education, self-help materials, and NRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this condition were provided with four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco. Strategies for quitting smoking were also provided to participants in this group as well as a supply of NRT and counseling on its use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>individualized counselor-led MI sessions</intervention_name>
    <description>Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.</description>
    <arm_group_label>individualized counselor-led MI sessions and NRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>general health education session</intervention_name>
    <description>four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.</description>
    <arm_group_label>general health education, self-help materials, and NRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NRT</intervention_name>
    <description>nicotine replacement therapy</description>
    <arm_group_label>general health education, self-help materials, and NRT</arm_group_label>
    <arm_group_label>individualized counselor-led MI sessions and NRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary eligibility criterion for inclusion in the study cohort was current smoking&#xD;
             status. Other inclusion criteria were:&#xD;
&#xD;
               1. self-identification as ethnic Chinese,&#xD;
&#xD;
               2. aged 18 years and older,&#xD;
&#xD;
               3. having smoked or puffed on a cigarette during the previous week,&#xD;
&#xD;
               4. willingness to participate in the smoking cessation study,&#xD;
&#xD;
               5. access to a functional telephone,&#xD;
&#xD;
               6. expected presence in the study geographic area for a year or more, and&#xD;
&#xD;
               7. not having been enrolled in the past or at the current time in any smoking&#xD;
                  cessation treatment programs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. being currently pregnant and&#xD;
&#xD;
          2. having had a recent diagnosis of cardiovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace X Ma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Asian Health, Lewis Katz School of Medicine, Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13.</citation>
    <PMID>19915080</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</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/NCT04489524
org study id: Quit Smoking
secondary id: U01CA114582-02S2
nct id: NCT04489524
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The investigators tested the feasibility of a culturally and linguistically sensitive smoking
      cessation program with combined counseling and pharmacological components for Chinese smokers
      in New York City; identified factors and techniques that enhance the administration and
      appropriateness of the intervention program; and examined the effectiveness of this program
      on quit attempts, quit rates, and overall smoking reduction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change in smoking behavior
time frame: baseline, 1 week, 1, 3, and 6-month
description: participants were asked whether they had smoked or had a puff on a cigarette and the number of cigarettes smoked in the past 7 days at multiple assessment points.
measure: change in Carbon monoxide (CO) concentration
time frame: baseline, 6-month follow-up
description: CO, a biomarker of smoking status, was assessed at baseline and 6-m follow up
measure: change in the stages of smoking cessation
time frame: baseline, 1 week, 1, 3, and 6-month
description: According to Prochaska and DiClemente ' s Stages of Change model, the stages are: precontemplation, contemplation, preparation, action, and maintenance. It's an ordinal variable that measured at multiple assessment points
arm group label: individualized counselor-led MI sessions and NRT
arm group type: Experimental
description: The intervention (4 individualized counselor-led MI sessions and nicotine replacement therapy [NRT]) consisted of four 60-min in-person sessions of AMI counseling and a packet of self-help smoking cessation materials. Participants were provided NRT packs and counseled on their use.
arm group label: general health education, self-help materials, and NRT
arm group type: Active Comparator
description: Participants in this condition were provided with four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco. Strategies for quitting smoking were also provided to participants in this group as well as a supply of NRT and counseling on its use.
intervention type: Behavioral
intervention name: individualized counselor-led MI sessions
description: Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.
arm group label: individualized counselor-led MI sessions and NRT
intervention type: Behavioral
intervention name: general health education session
description: four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.
arm group label: general health education, self-help materials, and NRT
intervention type: Behavioral
intervention name: NRT
description: nicotine replacement therapy
arm group label: general health education, self-help materials, and NRT
arm group label: individualized counselor-led MI sessions and NRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Grace X Ma, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
citation: Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13.
PMID: 19915080
responsible party type: Sponsor