<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/NCT03291587</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00040071</org_study_id>
    <secondary_id>1R01CA207158-01</secondary_id>
    <secondary_id>REBAWF-20817CD</secondary_id>
    <secondary_id>NCI-2017-01669</secondary_id>
    <nct_id>NCT03291587</nct_id>
  </id_info>
  <brief_title>Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites</brief_title>
  <acronym>OaSiS</acronym>
  <official_title>Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluate a multi-faceted training program to improve short-term smoking cessation rates (&lt;14&#xD;
      days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114&#xD;
      enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in&#xD;
      26 community-based practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized&#xD;
      control trial of community-based NCORP sites to study the effectiveness of a multi-faceted&#xD;
      intervention to improve smoking cessation among lung cancer screening patients, as well as&#xD;
      dissemination and implementation (D&amp;I) science to optimize and accelerate translation of&#xD;
      findings into clinical practice. We will: (1) Evaluate a multi-faceted training program to&#xD;
      improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6&#xD;
      months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer&#xD;
      screening in community-based lung cancer screening practices; (2) Characterize the adoption&#xD;
      and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT&#xD;
      lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for&#xD;
      integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer&#xD;
      screening programs. Qualitative data will be collected from key informants at participating&#xD;
      screening programs during and after intervention implementation. Quantitative survey data&#xD;
      (baseline, &lt;14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be&#xD;
      collected from smoking patients receiving screening within these programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">February 22, 2021</completion_date>
  <primary_completion_date type="Actual">February 22, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey</measure>
    <time_frame>6 months (after baseline)</time_frame>
    <description>7-day sustained smoking abstinence will be measured by the question &quot;Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?&quot; in patient survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary Cotinine Test for Non-Smokers</measure>
    <time_frame>6 months (after baseline)</time_frame>
    <description>7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-term Smoking Abstinence - Patient Survey</measure>
    <time_frame>3 months (after baseline)</time_frame>
    <description>Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Services Participant Reported Received at 14 Days</measure>
    <time_frame>&lt;= 14 days after baseline</time_frame>
    <description>Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1094</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (US PHS) Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personnel Training and Coaching Calls</intervention_name>
    <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agrees to have NCORP research personnel serve as the study liaison and another person&#xD;
             to serve as the cessation program champion.&#xD;
&#xD;
          -  Agrees to participate in all aspects of the intervention, randomization, and&#xD;
             evaluation.&#xD;
&#xD;
          -  Agrees to participate in a confidential 1-on-1 semi-structured interview with the&#xD;
             research team.&#xD;
&#xD;
          -  Agrees to have the interview taped, transcribed and qualitatively analyzed.&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Potential participants will be screened using the following question: &quot;Do you smoke&#xD;
             cigarettes every day, some days, or not at all?&quot; (BRFSS). A current smoker is anyone&#xD;
             responds &quot;every day&quot; or &quot;some days&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use (previous 30 days) of a tobacco dependence treatment including bupropion,&#xD;
             varenicline, and nicotine replacement&#xD;
&#xD;
          -  Individuals who use e-cigarettes and who are not smoking cigarettes. Dual users (those&#xD;
             who use both e-cigarettes and cigarettes) will still be included in the trial.&#xD;
&#xD;
          -  The presence of a physical or cognitive impairment that would prevent a person from&#xD;
             engaging in survey research (such as blindness, deafness, or dementia).&#xD;
&#xD;
          -  Individual has already completed the intended LDCT lung cancer screening for this&#xD;
             study.&#xD;
&#xD;
          -  Non-English speaking participants.&#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>Kristie Foley, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helen F Graham Cancer Center</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis Cancer and Research Pavilion at Saint Joseph's/Candler</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tripler Army Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96859</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Regional Health Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic PC - Ames</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center at Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health at Butterworth Campus</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital-Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridgeview Medical Center</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-Ballwin</name>
      <address>
        <city>Ballwin</city>
        <state>Missouri</state>
        <zip>63011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Bolivar</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>65613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cox Cancer Center Branson</name>
      <address>
        <city>Branson</city>
        <state>Missouri</state>
        <zip>65616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Health System</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Joplin</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delbert Day Cancer Institute at PCRMC</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic-Rolla-Cancer and Hematology</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-South City</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Washington</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Forsyth Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford South University Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adena Regional Medical Center</name>
      <address>
        <city>Chillicothe</city>
        <state>Ohio</state>
        <zip>45601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Spartanburg</name>
      <address>
        <city>Boiling Springs</city>
        <state>South Carolina</state>
        <zip>29316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Laurens</name>
      <address>
        <city>Clinton</city>
        <state>South Carolina</state>
        <zip>29325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Easley</name>
      <address>
        <city>Easley</city>
        <state>South Carolina</state>
        <zip>29640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Butternut</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Faris</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Greenville Memorial Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Eastside</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Greer</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Seneca</name>
      <address>
        <city>Seneca</city>
        <state>South Carolina</state>
        <zip>29672</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital and Cancer Center-Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center at Stony Point</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gundersen Lutheran Medical Center</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx?FriendlyError=InvalidNCAID</url>
    <description>Medicare Coverage Database - Centers for Medicare &amp; Medicaid Services</description>
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  <link>
    <url>http://hr.mit.edu/learning-topics/leading/articles/what-is-coaching</url>
    <description>Johnson. HR at MIT | Learning &amp; Development | What is Coaching?</description>
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    <url>http://ije.oxfordjournals.org/content/30/2/407.2</url>
    <description>Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000</description>
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  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>February 28, 2022</results_first_submitted>
  <results_first_submitted_qc>July 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2022</results_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>cancer screening</keyword>
  <keyword>tobacco use</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Wake Forest (WF) NCORP Research Base (RB) is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials (https://nctn-data-archive.nci.nih.gov/). This will become the primary means for sharing raw data and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.</ipd_description>
    <ipd_time_frame>see NIH policy</ipd_time_frame>
    <ipd_access_criteria>request using uniform resource locator (URL) below</ipd_access_criteria>
    <ipd_url>https://nctn-data-archive.nci.nih.gov/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03291587/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03291587/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Twenty-six radiology facilities in twenty states were selected to participate. Clinics were matched based on lung screening volume and racial/ethnic diversity, and then assigned to the intervention or usual care group. Radiology facilities in the intervention arm participated in multi-faceted implementation strategies targeting the radiology facility and its clinical team. Each clinic was asked to recruit 50 participants.</recruitment_details>
      <pre_assignment_details>Goal was 1100 and there were 6 participants later found to be ineligible due to mis-specified eligibility criteria which is why we have 1094 total.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="523">5 were found ineligible after baseline</participants>
                <participants group_id="P2" count="571">1 was found ineligible after baseline</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>14 Day Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="483">32 could not be reached, 1 not interested, 4 too busy to participate, 1 site withdrew, 1 previously consented and removed from study, 1 personal health reasons</participants>
                <participants group_id="P2" count="547">22 could not be reached, 1 too busy to participate, 1 not interested in participating.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="445">63 could not be reached, 2 refused to answer, 2 expired, 4 not interested in participating, 1 personal health reasons</participants>
                <participants group_id="P2" count="538">26 could not be reached, 2 expired, and 3 not interested in participating</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="442">62 could not be reached, 3 refused to answer, 2 not interested in participating, 1 personal health reason</participants>
                <participants group_id="P2" count="514">43 could not be reached,2 refused to answer, 2 expired, and 2 not interested in participating</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused to Answer</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not interested in participating</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Too busy to participate</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>1094 excludes the 6 that were deemed ineligible from the total of 1100 recruited</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="523"/>
            <count group_id="B2" value="571"/>
            <count group_id="B3" value="1094"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age in years</title>
              <category_list>
                <category>
                  <title>55-64</title>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                    <measurement group_id="B2" value="333"/>
                    <measurement group_id="B3" value="619"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65-74</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="220"/>
                    <measurement group_id="B3" value="433"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75 or older</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender, participant reported</title>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="249"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="530"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                    <measurement group_id="B2" value="283"/>
                    <measurement group_id="B3" value="552"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Binary</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White, non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="423"/>
                    <measurement group_id="B2" value="452"/>
                    <measurement group_id="B3" value="875"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black, non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic, all races</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian, non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No high school degree, high school degree, or completion of General Education Development (GED) test</title>
                  <measurement_list>
                    <measurement group_id="B1" value="248"/>
                    <measurement group_id="B2" value="307"/>
                    <measurement group_id="B3" value="555"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some post high school education or college degree or graduate degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="260"/>
                    <measurement group_id="B3" value="532"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Household Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than $15000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$15000 - $34999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$35000 - $64999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="232"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$65000 or higher</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="265"/>
                    <measurement group_id="B2" value="284"/>
                    <measurement group_id="B3" value="549"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Currently Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="254"/>
                    <measurement group_id="B2" value="283"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Working full- or part-time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="187"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Retired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="226"/>
                    <measurement group_id="B2" value="226"/>
                    <measurement group_id="B3" value="452"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disabled</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Homemaker, Caregiver, Student, or Unemployed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Personal Cancer History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family Cancer History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoke a cigarette within 30 minutes of waking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="372"/>
                    <measurement group_id="B2" value="403"/>
                    <measurement group_id="B3" value="775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes per day</title>
          <units>number of cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.3" spread="10.4"/>
                    <measurement group_id="B2" value="17.1" spread="8.9"/>
                    <measurement group_id="B3" value="17.2" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pack Years</title>
          <description>It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.</description>
          <units>pack of cigarettes per day per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.7" spread="25.7"/>
                    <measurement group_id="B2" value="46.5" spread="24.3"/>
                    <measurement group_id="B3" value="46.1" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Another smoker in the household</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey</title>
        <description>7-day sustained smoking abstinence will be measured by the question &quot;Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?&quot; in patient survey.</description>
        <time_frame>6 months (after baseline)</time_frame>
        <population>Those with completed 6 month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey</title>
          <description>7-day sustained smoking abstinence will be measured by the question &quot;Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?&quot; in patient survey.</description>
          <population>Those with completed 6 month surveys.</population>
          <units>percentage of participants</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="442"/>
                <count group_id="O2" value="514"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="9.7" upper_limit="17.4"/>
                    <measurement group_id="O2" value="13.5" lower_limit="10.3" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.</non_inferiority_desc>
            <p_value>0.865</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.967</param_value>
            <ci_percent>96</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.652</ci_lower_limit>
            <ci_upper_limit>1.433</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Salivary Cotinine Test for Non-Smokers</title>
        <description>7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.</description>
        <time_frame>6 months (after baseline)</time_frame>
        <population>Cotinine was requested only for those that self-reported quitting for at least 7 days at the 6 month survey.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (US PHS) Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Salivary Cotinine Test for Non-Smokers</title>
          <description>7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.</description>
          <population>Cotinine was requested only for those that self-reported quitting for at least 7 days at the 6 month survey.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High: greater than or equal to 15 mg/mL</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Low: Less than 15 mg/mL</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown, not tested</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short-term Smoking Abstinence - Patient Survey</title>
        <description>Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.</description>
        <time_frame>3 months (after baseline)</time_frame>
        <population>Those that had 3 month surveys complete</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Short-term Smoking Abstinence - Patient Survey</title>
          <description>Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.</description>
          <population>Those that had 3 month surveys complete</population>
          <units>percentage of participants</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="445"/>
                <count group_id="O2" value="538"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="4.4" upper_limit="9.5"/>
                    <measurement group_id="O2" value="5.5" lower_limit="3.8" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Services Participant Reported Received at 14 Days</title>
        <description>Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.</description>
        <time_frame>&lt;= 14 days after baseline</time_frame>
        <population>Those that completed 14 day survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Services Participant Reported Received at 14 Days</title>
          <description>Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.</description>
          <population>Those that completed 14 day survey</population>
          <units>total services reported</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="547"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.51" spread="6.33"/>
                    <measurement group_id="O2" value="7.86" spread="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Adverse events were not collected as part of this protocol. All-Cause Mortality was not systematically collected or requested, unless a site reported a death when trying to assess the participant at a follow-up visit during the study duration of 6 months and we provide those known cases below.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)&#xD;
Personnel Training and Coaching Calls: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study&#xD;
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>No training or performance coaching calls on personnel, just usual clinic practice.&#xD;
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, &lt;14 days, 3 months, and 6 months)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="523"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="571"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Some sites dropped out early and did not accrue all 50 participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lead Biostatistician</name_or_title>
      <organization>Wake Forest NCORP Research Base</organization>
      <phone>3367160891</phone>
      <email>NCORP@wakehealth.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03291587
org study id: IRB00040071
secondary id: 1R01CA207158-01
secondary id: REBAWF-20817CD
secondary id: NCI-2017-01669
nct id: NCT03291587
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate a multi-faceted training program to improve short-term smoking cessation rates (<14
      days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114
      enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in
      26 community-based practices.
We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized
      control trial of community-based NCORP sites to study the effectiveness of a multi-faceted
      intervention to improve smoking cessation among lung cancer screening patients, as well as
      dissemination and implementation (D&I) science to optimize and accelerate translation of
      findings into clinical practice. We will: (1) Evaluate a multi-faceted training program to
      improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6
      months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer
      screening in community-based lung cancer screening practices; (2) Characterize the adoption
      and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT
      lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for
      integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer
      screening programs. Qualitative data will be collected from key informants at participating
      screening programs during and after intervention implementation. Quantitative survey data
      (baseline, <14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be
      collected from smoking patients receiving screening within these programs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
time frame: 6 months (after baseline)
description: 7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.
measure: Salivary Cotinine Test for Non-Smokers
time frame: 6 months (after baseline)
description: 7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine. Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.
measure: Short-term Smoking Abstinence - Patient Survey
time frame: 3 months (after baseline)
description: Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.
measure: Total Number of Services Participant Reported Received at 14 Days
time frame: <= 14 days after baseline
description: Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit. This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.
arm group label: Intervention
arm group type: Experimental
description: Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (US PHS) Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months)
arm group label: Usual Care
arm group type: No Intervention
description: No training or performance coaching calls on personnel, just usual clinic practice.
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months)
intervention type: Other
intervention name: Personnel Training and Coaching Calls
description: Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristie Foley, PhD
role: Study Chair
affiliation: Wake Forest University Health Sciences
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country: United States
url: http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx?FriendlyError=InvalidNCAID
description: Medicare Coverage Database - Centers for Medicare & Medicaid Services
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responsible party type: Sponsor
sharing ipd: Yes
ipd description: Wake Forest (WF) NCORP Research Base (RB) is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials (https://nctn-data-archive.nci.nih.gov/). This will become the primary means for sharing raw data and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
ipd time frame: see NIH policy
ipd access criteria: request using uniform resource locator (URL) below
ipd url: https://nctn-data-archive.nci.nih.gov/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Some sites dropped out early and did not accrue all 50 participants.
point of contact: 