<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/NCT03808818</url>
  </required_header>
  <id_info>
    <org_study_id>EAQ171CD</org_study_id>
    <secondary_id>NCI-2018-02826</secondary_id>
    <secondary_id>EAQ171CD</secondary_id>
    <secondary_id>ECOG-ACRIN-EAQ171CD</secondary_id>
    <secondary_id>EAQ171CD</secondary_id>
    <secondary_id>R01CA214427</secondary_id>
    <nct_id>NCT03808818</nct_id>
  </id_info>
  <brief_title>Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices</brief_title>
  <official_title>Implementing a Virtual Tobacco Treatment in Community Oncology Practices: &quot;Smoke Free Support Study 2.0&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECOG-ACRIN Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Cooperative Oncology Group</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>
      This phase II trial studies how well smoking cessation treatment plans work in&#xD;
      tobacco-dependent cancer patients when delivered virtually as part of their cancer care in&#xD;
      community oncology practices. Virtual information and counseling sessions may help cancer&#xD;
      patients quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual&#xD;
      Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence&#xD;
      abstinence from cigarettes at 6-months post enrollment.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.&#xD;
&#xD;
      II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.&#xD;
&#xD;
      III. Significant reduction (&gt; 50% reduction in reported number of cigarettes per day) in&#xD;
      daily smoking from baseline to 3- and baseline to 6-months follow-up.&#xD;
&#xD;
      IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at&#xD;
      6 months (cotinine-verified at 3-months and 6-months).&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To assess the potential effect of known and potential moderators on treatment&#xD;
      effectiveness between the two arms.&#xD;
&#xD;
      II. To assess the processes of implementation and dissemination (acceptability, adoption,&#xD;
      appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and&#xD;
      sustainability) of the investigator's intervention at community oncology sites.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A (Enhanced Usual Care [EUC]): Patients receive an assessment of smoking status and&#xD;
      provision of quitting advice through the screening and referral process, and are referred to&#xD;
      the National Cancer Institute (NCI) Smoking Quitline.&#xD;
&#xD;
      ARM B (Virtual Intervention Treatment [VIT]): Patients receive an initial virtual counseling&#xD;
      session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes&#xD;
      and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months.&#xD;
      Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge&#xD;
      combined or alone).&#xD;
&#xD;
      After completion of study, patients may be followed up for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)</measure>
    <time_frame>At 6 months</time_frame>
    <description>Will define 7-day point-prevalence by saliva cotinine (&lt; 15 ng/ml) or expired air CO (&lt; 10 ppm). All participants who report being quit and no nicotine replacement (NRT) or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemically-confirmed 7-day point prevalence abstinence by saliva cotinine or expired air CO</measure>
    <time_frame>At 3 months</time_frame>
    <description>Will define 7-day point-prevalence by saliva cotinine (&lt; 15 ng/ml) or expired air CO (&lt; 10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported 7-day point prevalence abstinence</measure>
    <time_frame>At 3 months</time_frame>
    <description>Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported 7-day point prevalence abstinence</measure>
    <time_frame>At 6 months</time_frame>
    <description>Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported continuous tobacco abstinence</measure>
    <time_frame>At 6 months</time_frame>
    <description>Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained tobacco abstinence at 6 months</measure>
    <time_frame>At 6 months</time_frame>
    <description>To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Potential effect of sociodemographics on treatment effectiveness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Potential effect of medical and smoking history on treatment effectiveness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Potential effect of cancer variables on treatment effectiveness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.</description>
  </other_outcome>
  <other_outcome>
    <measure>Implementation of the intervention at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention acceptability (satisfaction with content/delivery) at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention adoption (program uptake) at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention appropriateness (relevance) at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention cost at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment fidelity/adaptation at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention penetration (reach) at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention sustainability at community oncology sites</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Outcome will be assessed with mixed methods using qualitative &amp; quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">580</enrollment>
  <condition>Carcinoma In Situ</condition>
  <condition>Current Smoker</condition>
  <condition>Malignant Neoplasm</condition>
  <condition>Primary Neoplasm</condition>
  <condition>Recurrent Neoplasm</condition>
  <arm_group>
    <arm_group_label>Arm A (smoking assessment, quitting advice, Quitline referral)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (virtual counseling sessions, NRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Behavioral, Psychological or Informational Intervention</intervention_name>
    <description>Receive information about tobacco cessation</description>
    <arm_group_label>Arm A (smoking assessment, quitting advice, Quitline referral)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Replacement</intervention_name>
    <description>Given NRT patch or lozenge (or both)</description>
    <arm_group_label>Arm B (virtual counseling sessions, NRT)</arm_group_label>
    <other_name>Nicotine Replacement Therapy</other_name>
    <other_name>NRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (smoking assessment, quitting advice, Quitline referral)</arm_group_label>
    <arm_group_label>Arm B (virtual counseling sessions, NRT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm B (virtual counseling sessions, NRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tobacco Cessation Counseling</intervention_name>
    <description>Receive virtual tobacco cessation counseling</description>
    <arm_group_label>Arm B (virtual counseling sessions, NRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STAFF ELIGIBILITY CRITERIA:&#xD;
&#xD;
          -  Must be English speaking.&#xD;
&#xD;
          -  Must be employed at NCI Community Oncology Research Program (NCORP) site for at least&#xD;
             three months.&#xD;
&#xD;
          -  PATIENT ELIGIBILITY CRITERIA STEP 0:&#xD;
&#xD;
          -  Patient presenting with any type of cancer with a date of diagnosis within the past 4&#xD;
             months. Recurrence, diagnosed within the last 4 months, of tumors in patients with&#xD;
             past cancer diagnoses will be considered eligible. Patients with a new primary cancer,&#xD;
             diagnosed within the last 4 months, who have been treated previously for other types&#xD;
             of cancer will also be considered eligible. ?In situ? cancers, diagnosed within the&#xD;
             past 4 months, will also be considered eligible.&#xD;
&#xD;
          -  Patient must be a current smoker. Current smoker is defined as any cigarette smoking&#xD;
             (even a puff) in the past 30 days.&#xD;
&#xD;
          -  Patient must be fluent in both, written and spoken, English or both, written and&#xD;
             spoken, Spanish.&#xD;
&#xD;
          -  Patient must have telephone, e-mail access, and have access to the internet with a&#xD;
             camera-enabled device (e.g., smartphone, tablet, computer, laptop with a&#xD;
             webcam/camera)&#xD;
&#xD;
               -  NOTE: The restriction to those with web and e-mail access is based on the primary&#xD;
                  intention of the study; to assess the implementation of the virtual intervention&#xD;
                  in the NCORP network.&#xD;
&#xD;
          -  ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0.&#xD;
&#xD;
          -  ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in&#xD;
             Eastern Cooperative Oncology Group-American College of Radiology Imaging Network&#xD;
             (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes&#xD;
             (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or&#xD;
             above, or is deemed medically unable to participate by study investigators or oncology&#xD;
             clinician (i.e., referral to hospice).&#xD;
&#xD;
          -  Patient has no intention to receive their cancer care or monitoring at an NCORP&#xD;
             community cancer site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elyse Park</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alaska Women's Cancer Care</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katmai Oncology Group</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</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>Carle on Vermilion</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</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>Physicians' Clinic of Iowa PC</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital and Cancer Center-Desoto</name>
      <address>
        <city>Southhaven</city>
        <state>Mississippi</state>
        <zip>38671</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>Heartland Regional Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</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>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>CaroMont Regional Medical Center</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Margaret R Pardee Memorial Hospital</name>
      <address>
        <city>Hendersonville</city>
        <state>North Carolina</state>
        <zip>28791</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strecker Cancer Center-Belpre</name>
      <address>
        <city>Belpre</city>
        <state>Ohio</state>
        <zip>45714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Memorial Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Ohio</state>
        <zip>45750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Marion General Hospital</name>
      <address>
        <city>Marion</city>
        <state>Ohio</state>
        <zip>43302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Ohio Medical Center</name>
      <address>
        <city>Portsmouth</city>
        <state>Ohio</state>
        <zip>45662</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 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>Prisma Health Cancer Institute - Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29307</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>Baptist Memorial Hospital for Women</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Auburn Medical Center</name>
      <address>
        <city>Auburn</city>
        <state>Washington</state>
        <zip>98001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Gig Harbor Medical Park</name>
      <address>
        <city>Gig Harbor</city>
        <state>Washington</state>
        <zip>98335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Good Samaritan Hospital</name>
      <address>
        <city>Puyallup</city>
        <state>Washington</state>
        <zip>98372</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Tacoma General Hospital</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ThedaCare Regional Cancer Center</name>
      <address>
        <city>Appleton</city>
        <state>Wisconsin</state>
        <zip>54911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Saint Mary's</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora BayCare Medical Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Oconto Falls</name>
      <address>
        <city>Oconto Falls</city>
        <state>Wisconsin</state>
        <zip>54154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS Saint Nicholas Hospital</name>
      <address>
        <city>Sheboygan</city>
        <state>Wisconsin</state>
        <zip>53081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Sturgeon Bay</name>
      <address>
        <city>Sturgeon Bay</city>
        <state>Wisconsin</state>
        <zip>54235-1495</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 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>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03808818
org study id: EAQ171CD
secondary id: NCI-2018-02826
secondary id: EAQ171CD
secondary id: ECOG-ACRIN-EAQ171CD
secondary id: EAQ171CD
secondary id: R01CA214427
nct id: NCT03808818
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This phase II trial studies how well smoking cessation treatment plans work in
      tobacco-dependent cancer patients when delivered virtually as part of their cancer care in
      community oncology practices. Virtual information and counseling sessions may help cancer
      patients quit smoking.
PRIMARY OBJECTIVE:

      I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual
      Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence
      abstinence from cigarettes at 6-months post enrollment.

      SECONDARY OBJECTIVES:

      I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.

      II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.

      III. Significant reduction (> 50% reduction in reported number of cigarettes per day) in
      daily smoking from baseline to 3- and baseline to 6-months follow-up.

      IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at
      6 months (cotinine-verified at 3-months and 6-months).

      EXPLORATORY OBJECTIVES:

      I. To assess the potential effect of known and potential moderators on treatment
      effectiveness between the two arms.

      II. To assess the processes of implementation and dissemination (acceptability, adoption,
      appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and
      sustainability) of the investigator's intervention at community oncology sites.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A (Enhanced Usual Care [EUC]): Patients receive an assessment of smoking status and
      provision of quitting advice through the screening and referral process, and are referred to
      the National Cancer Institute (NCI) Smoking Quitline.

      ARM B (Virtual Intervention Treatment [VIT]): Patients receive an initial virtual counseling
      session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes
      and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months.
      Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge
      combined or alone).

      After completion of study, patients may be followed up for 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: 7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)
time frame: At 6 months
description: Will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit and no nicotine replacement (NRT) or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Biochemically-confirmed 7-day point prevalence abstinence by saliva cotinine or expired air CO
time frame: At 3 months
description: Will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Self-reported 7-day point prevalence abstinence
time frame: At 3 months
description: Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Self-reported 7-day point prevalence abstinence
time frame: At 6 months
description: Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Self-reported continuous tobacco abstinence
time frame: At 6 months
description: Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Sustained tobacco abstinence at 6 months
time frame: At 6 months
description: To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.
measure: Potential effect of sociodemographics on treatment effectiveness
time frame: Up to 6 months
description: Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.
measure: Potential effect of medical and smoking history on treatment effectiveness
time frame: Up to 6 months
description: Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.
measure: Potential effect of cancer variables on treatment effectiveness
time frame: Up to 6 months
description: Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.
measure: Implementation of the intervention at community oncology sites
time frame: Up to 36 months
description: Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability).
measure: Intervention acceptability (satisfaction with content/delivery) at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Intervention adoption (program uptake) at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Intervention appropriateness (relevance) at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Intervention cost at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Treatment fidelity/adaptation at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Intervention penetration (reach) at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
measure: Intervention sustainability at community oncology sites
time frame: Up to 36 months
description: Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.
arm group label: Arm A (smoking assessment, quitting advice, Quitline referral)
arm group type: Active Comparator
description: Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.
arm group label: Arm B (virtual counseling sessions, NRT)
arm group type: Experimental
description: Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).
intervention type: Other
intervention name: Behavioral, Psychological or Informational Intervention
description: Receive information about tobacco cessation
arm group label: Arm A (smoking assessment, quitting advice, Quitline referral)
intervention type: Drug
intervention name: Nicotine Replacement
description: Given NRT patch or lozenge (or both)
arm group label: Arm B (virtual counseling sessions, NRT)
other name: Nicotine Replacement Therapy
other name: NRT
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (smoking assessment, quitting advice, Quitline referral)
arm group label: Arm B (virtual counseling sessions, NRT)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Arm B (virtual counseling sessions, NRT)
intervention type: Other
intervention name: Tobacco Cessation Counseling
description: Receive virtual tobacco cessation counseling
arm group label: Arm B (virtual counseling sessions, NRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elyse Park
role: Principal Investigator
affiliation: ECOG-ACRIN Cancer Research Group
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country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Recurrence
mesh term: Nicotine