<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/NCT03238456</url>
  </required_header>
  <id_info>
    <org_study_id>U54CA153458</org_study_id>
    <secondary_id>U54CA153458</secondary_id>
    <nct_id>NCT03238456</nct_id>
  </id_info>
  <brief_title>Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco</brief_title>
  <acronym>MPACT</acronym>
  <official_title>Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology &amp; Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claremont Graduate University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Claremont Graduate University</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 current study aimed to test a culturally tailored program designed to help Pacific&#xD;
      Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized&#xD;
      controlled trial design with one intervention group and one control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three&#xD;
      follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5&#xD;
      months, and 8 months after the baseline assessment. The objective of the study was to test a&#xD;
      culturally-tailored online program designed to help PI young adults quit smoking cigarettes.&#xD;
      The online program contained (1) personalized, automated text messages, (2) interactive,&#xD;
      online educational modules, and (3) an online forum.&#xD;
&#xD;
      Hypotheses for this study include:&#xD;
&#xD;
        1. Participants in the intervention program tailored to PIs would have significantly higher&#xD;
           rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity&#xD;
           at each follow-up time point than those in the standard intervention program.&#xD;
&#xD;
        2. Participants with impaired affective decision capacity (low scores on Iowa Gambling Task&#xD;
           (IGT)) would benefit more from the tailored intervention program than participants with&#xD;
           normal affective decision capacity (high IGT scores).&#xD;
&#xD;
        3. Effects from the tailored intervention program would be more pronounced among&#xD;
           participants with particular dispositional phenotypes (depression, hostility,&#xD;
           impulsivity) and baseline severity of tobacco addiction (nicotine dependence).&#xD;
&#xD;
        4. High-intensity users of the tailored intervention program would be more successful than&#xD;
           low intensity users in reducing the frequency and intensity of cigarettes smoked.&#xD;
&#xD;
        5. The tailored intervention program would have greater success at engaging and retaining&#xD;
           participants than the standard intervention program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2013</start_date>
  <completion_date type="Actual">May 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 3, 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cigarettes smoked in last 30 days</measure>
    <time_frame>8 months</time_frame>
    <description>How many cigarettes has the participant smoked in the last 30 days?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cigarette smoked in past 7 days</measure>
    <time_frame>8 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 7 days?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cigarette smoked in past 24 hours</measure>
    <time_frame>8 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 24 hours?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expired carbon monoxide (CO)</measure>
    <time_frame>8 months</time_frame>
    <description>Biomarker validation (expired CO) of self-reported tobacco use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of cigarettes smoked in last 30 days</measure>
    <time_frame>2 months</time_frame>
    <description>How many cigarettes has the participant smoked in the last 30 days?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cigarettes smoked in last 30 days</measure>
    <time_frame>5 months</time_frame>
    <description>How many cigarettes has the participant smoked in the last 30 days?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarette smoked in past 7 days</measure>
    <time_frame>2 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 7 days?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarette smoked in past 7 days</measure>
    <time_frame>5 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 7 days?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarette smoked in past 24 hours</measure>
    <time_frame>2 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 24 hours?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarette smoked in past 24 hours</measure>
    <time_frame>5 months</time_frame>
    <description>Has the participant smoked a cigarette in the past 24 hours?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expired carbon monoxide (CO)</measure>
    <time_frame>2 months</time_frame>
    <description>Biomarker validation (expired CO) of self-reported tobacco use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expired carbon monoxide (CO)</measure>
    <time_frame>5 months</time_frame>
    <description>Biomarker validation (expired CO) of self-reported tobacco use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Tobacco Use</condition>
  <condition>Tobacco Smoking</condition>
  <condition>Tobacco Use Cessation</condition>
  <condition>Smoking</condition>
  <condition>Smoking Cessation</condition>
  <condition>Smoking, Cigarette</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment. At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program. The online program was accessed through the participant's Facebook account. The program included eight education modules and a forum. Participants also received automated daily text messages to provide support and encouragement during the quitting process.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program. They received one text message every other week over a period of eight weeks following the quit date. The messages were delivered by a web-based system not connected to the online intervention program. Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivating Pacifika Against Cigarettes and Tobacco</intervention_name>
    <description>Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline.&#xD;
The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>MPACT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified as Native Hawaiian or Pacific Islander&#xD;
&#xD;
          -  Between the ages 18 and 30&#xD;
&#xD;
          -  Lived in Southern California&#xD;
&#xD;
          -  Would be living in Southern California for the next year&#xD;
&#xD;
          -  Owned a cell phone with a text messaging plan&#xD;
&#xD;
          -  Had access to a computer with internet for at least 2 hours per week&#xD;
&#xD;
          -  Smoked daily or most days of the week (&gt;3 days)&#xD;
&#xD;
          -  Smoked at least 100 cigarettes in lifetime&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Was currently using another smoking cessation method&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Claremont Graduate University</name>
      <address>
        <city>Claremont</city>
        <state>California</state>
        <zip>91711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California State University Fullerton</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92831</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pacific Islander</keyword>
  <keyword>Native Hawaiian</keyword>
  <keyword>NHPI</keyword>
  <keyword>Tobacco Health</keyword>
  <keyword>Tobacco Use</keyword>
  <keyword>Tobacco Smoking</keyword>
  <keyword>Tobacco Use Cessation</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Smoking</keyword>
  <keyword>Cigarette Use</keyword>
  <keyword>Young Adult</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.</ipd_description>
  </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/NCT03238456
org study id: U54CA153458
secondary id: U54CA153458
nct id: NCT03238456
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aimed to test a culturally tailored program designed to help Pacific
      Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized
      controlled trial design with one intervention group and one control group.
This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three
      follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5
      months, and 8 months after the baseline assessment. The objective of the study was to test a
      culturally-tailored online program designed to help PI young adults quit smoking cigarettes.
      The online program contained (1) personalized, automated text messages, (2) interactive,
      online educational modules, and (3) an online forum.

      Hypotheses for this study include:

        1. Participants in the intervention program tailored to PIs would have significantly higher
           rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity
           at each follow-up time point than those in the standard intervention program.

        2. Participants with impaired affective decision capacity (low scores on Iowa Gambling Task
           (IGT)) would benefit more from the tailored intervention program than participants with
           normal affective decision capacity (high IGT scores).

        3. Effects from the tailored intervention program would be more pronounced among
           participants with particular dispositional phenotypes (depression, hostility,
           impulsivity) and baseline severity of tobacco addiction (nicotine dependence).

        4. High-intensity users of the tailored intervention program would be more successful than
           low intensity users in reducing the frequency and intensity of cigarettes smoked.

        5. The tailored intervention program would have greater success at engaging and retaining
           participants than the standard intervention program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of cigarettes smoked in last 30 days
time frame: 8 months
description: How many cigarettes has the participant smoked in the last 30 days?
measure: Cigarette smoked in past 7 days
time frame: 8 months
description: Has the participant smoked a cigarette in the past 7 days?
measure: Cigarette smoked in past 24 hours
time frame: 8 months
description: Has the participant smoked a cigarette in the past 24 hours?
measure: Expired carbon monoxide (CO)
time frame: 8 months
description: Biomarker validation (expired CO) of self-reported tobacco use
measure: Number of cigarettes smoked in last 30 days
time frame: 2 months
description: How many cigarettes has the participant smoked in the last 30 days?
measure: Number of cigarettes smoked in last 30 days
time frame: 5 months
description: How many cigarettes has the participant smoked in the last 30 days?
measure: Cigarette smoked in past 7 days
time frame: 2 months
description: Has the participant smoked a cigarette in the past 7 days?
measure: Cigarette smoked in past 7 days
time frame: 5 months
description: Has the participant smoked a cigarette in the past 7 days?
measure: Cigarette smoked in past 24 hours
time frame: 2 months
description: Has the participant smoked a cigarette in the past 24 hours?
measure: Cigarette smoked in past 24 hours
time frame: 5 months
description: Has the participant smoked a cigarette in the past 24 hours?
measure: Expired carbon monoxide (CO)
time frame: 2 months
description: Biomarker validation (expired CO) of self-reported tobacco use
measure: Expired carbon monoxide (CO)
time frame: 5 months
description: Biomarker validation (expired CO) of self-reported tobacco use
arm group label: Intervention
arm group type: Experimental
description: The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment. At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program. The online program was accessed through the participant's Facebook account. The program included eight education modules and a forum. Participants also received automated daily text messages to provide support and encouragement during the quitting process.
arm group label: Control
arm group type: No Intervention
description: Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program. They received one text message every other week over a period of eight weeks following the quit date. The messages were delivered by a web-based system not connected to the online intervention program. Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball.
intervention type: Behavioral
intervention name: Motivating Pacifika Against Cigarettes and Tobacco
description: Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline.
The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.
arm group label: Intervention
other name: MPACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.