<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/NCT04409236</url>
  </required_header>
  <id_info>
    <org_study_id>RG1007577</org_study_id>
    <secondary_id>NCI-2020-03442</secondary_id>
    <secondary_id>10432</secondary_id>
    <secondary_id>R01CA253975</secondary_id>
    <nct_id>NCT04409236</nct_id>
  </id_info>
  <brief_title>Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking</brief_title>
  <official_title>Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking (Quit2Heal)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson 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>
      This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to&#xD;
      the QuitGuide app in helping cancer patients quit smoking. Both apps provide tools to cope&#xD;
      with urges to smoke, step-by-step guides for quitting smoking, help in planning for quitting&#xD;
      and staying tobacco-free, and scientifically-based recommendations for how to select&#xD;
      medications that aid in smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive the Quit2Heal app and are encouraged to use it frequently. During the&#xD;
      entire 12-month follow-up period, the app will remain fully available anytime study&#xD;
      participants wish to use it.&#xD;
&#xD;
      ARM II: Patients receive the QuitGuide app and are encouraged to use it frequently. During&#xD;
      the entire 12-month follow-up period, the app will remain fully available anytime study&#xD;
      participants wish to use it.&#xD;
&#xD;
      After randomization, patients are followed up at 3, 6, and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 19, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with 30-day cigarette smoking cessation at 12 months.</measure>
    <time_frame>At 12 months after randomization</time_frame>
    <description>No smoking at all in the past 30 or more days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with 30-day cigarette smoking cessation at 3 months.</measure>
    <time_frame>At 3 months after randomization</time_frame>
    <description>No smoking at all in the past 30 or more days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with 30-day cigarette smoking cessation at 6 months.</measure>
    <time_frame>At 6 months after randomization</time_frame>
    <description>No smoking at all in the past 30 or more days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">422</enrollment>
  <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Arm I (Quit2Heal app)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (QuitGuide app)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quit2Heal</intervention_name>
    <description>Use Quit2Heal app</description>
    <arm_group_label>Arm I (Quit2Heal app)</arm_group_label>
    <other_name>Quit2Heal App</other_name>
    <other_name>Quit2Heal Smartphone App</other_name>
    <other_name>Quit2Heal Smartphone Application</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>QuitGuide</intervention_name>
    <description>Use QuitGuide app</description>
    <arm_group_label>Arm II (QuitGuide app)</arm_group_label>
    <other_name>QuitGuide App</other_name>
    <other_name>QuitGuide Smartphone App</other_name>
    <other_name>QuitGuide Smartphone Application</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (Quit2Heal app)</arm_group_label>
    <arm_group_label>Arm II (QuitGuide app)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Diagnosed with cancer within the past 24 months or currently receiving or planning to&#xD;
             receive cancer treatment in the next 3 months&#xD;
&#xD;
          -  Smoked a cigarette (even a puff) in the past 30 days&#xD;
&#xD;
          -  Interested in learning skills to quit smoking&#xD;
&#xD;
          -  Willing to be randomly assigned to either smartphone application&#xD;
&#xD;
          -  Live in the United States and will remain in the United States (US) for the next 12&#xD;
             months&#xD;
&#xD;
          -  Have at least daily access to their own smartphone&#xD;
&#xD;
          -  Know how to download a smartphone application&#xD;
&#xD;
          -  Be willing and able to read English&#xD;
&#xD;
          -  Not currently (i.e., within past 30 days) using other smoking cessation interventions&#xD;
&#xD;
          -  Have never participated in our prior research trials&#xD;
&#xD;
          -  Have never used the National Cancer Institute (NCI)'s QuitGuide app&#xD;
&#xD;
          -  Being willing to complete a follow-up survey at 3, 6, and 12 months post-randomization&#xD;
&#xD;
          -  Providing email, phone number(s), and mailing address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently (i.e., within past 30 days) using other smoking cessation interventions&#xD;
&#xD;
          -  Has participated in our prior research trials&#xD;
&#xD;
          -  Has used the NCI's QuitGuide app&#xD;
&#xD;
          -  Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization&#xD;
&#xD;
          -  Not providing email, phone number(s), and mailing address&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Bricker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan Bricker</last_name>
    <phone>877-250-6641</phone>
    <email>quit2heal@fredhutch.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Bricker</last_name>
      <phone>877-250-6641</phone>
      <email>quit2heal@fredhutch.org</email>
    </contact>
    <investigator>
      <last_name>Jonathan Bricker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04409236
org study id: RG1007577
secondary id: NCI-2020-03442
secondary id: 10432
secondary id: R01CA253975
nct id: NCT04409236
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase III trial compares the Quit2Heal smoking cessation smartphone application (app) to
      the QuitGuide app in helping cancer patients quit smoking. Both apps provide tools to cope
      with urges to smoke, step-by-step guides for quitting smoking, help in planning for quitting
      and staying tobacco-free, and scientifically-based recommendations for how to select
      medications that aid in smoking cessation.
OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive the Quit2Heal app and are encouraged to use it frequently. During the
      entire 12-month follow-up period, the app will remain fully available anytime study
      participants wish to use it.

      ARM II: Patients receive the QuitGuide app and are encouraged to use it frequently. During
      the entire 12-month follow-up period, the app will remain fully available anytime study
      participants wish to use it.

      After randomization, patients are followed up at 3, 6, and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Number of participants with 30-day cigarette smoking cessation at 12 months.
time frame: At 12 months after randomization
description: No smoking at all in the past 30 or more days.
measure: Number of participants with 30-day cigarette smoking cessation at 3 months.
time frame: At 3 months after randomization
description: No smoking at all in the past 30 or more days.
measure: Number of participants with 30-day cigarette smoking cessation at 6 months.
time frame: At 6 months after randomization
description: No smoking at all in the past 30 or more days.
arm group label: Arm I (Quit2Heal app)
arm group type: Experimental
description: Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
arm group label: Arm II (QuitGuide app)
arm group type: Active Comparator
description: Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
intervention type: Behavioral
intervention name: Quit2Heal
description: Use Quit2Heal app
arm group label: Arm I (Quit2Heal app)
other name: Quit2Heal App
other name: Quit2Heal Smartphone App
other name: Quit2Heal Smartphone Application
intervention type: Behavioral
intervention name: QuitGuide
description: Use QuitGuide app
arm group label: Arm II (QuitGuide app)
other name: QuitGuide App
other name: QuitGuide Smartphone App
other name: QuitGuide Smartphone Application
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Arm I (Quit2Heal app)
arm group label: Arm II (QuitGuide app)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan Bricker
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
last name: Jonathan Bricker
phone: 877-250-6641
email: quit2heal@fredhutch.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No