<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/NCT01678118</url>
  </required_header>
  <id_info>
    <org_study_id>11-028</org_study_id>
    <nct_id>NCT01678118</nct_id>
  </id_info>
  <brief_title>Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care</brief_title>
  <official_title>Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sophie Davis School of Biomedical Education at The City College of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ralph Lauren Center for Cancer Care and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heritage Health Center, New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      Patient navigators have been shown to assist people seeking cancer screening and other&#xD;
      medical services. The purpose of this study is to see whether a patient navigator can link&#xD;
      smokers to available community resources shown to help smokers quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2011</start_date>
  <completion_date type="Actual">July 20, 2021</completion_date>
  <primary_completion_date type="Actual">July 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>patient navigation (TPN) feasibility</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the study's potential in terms of its reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of the intervention, tobacco-dependent patients will be asked to complete an intake interview and a telephone follow-up interview (at 3 to 6 months post-intervention).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Minority Smokers</condition>
  <arm_group>
    <arm_group_label>minority smokers</arm_group_label>
    <description>A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Navigator</intervention_name>
    <description>The pt navigator will phone (email, text, or other preferred method of contact) pts prior to the date of previously set individual goals (e.g. going to an appt, getting their cessation medications filled, etc) as a reminder &amp; to discuss barriers such as finances, transportation or ambivalent motivation. In this manner, pts receive navigation services tailored to their individual needs &amp; barriers. Once pts are connected with a cessation service (defined as either using cessation medication or at least 1 contact with a Quitline or community-based cessation counselor)or provider-prescribed cessation medication usage, continues the navigation intervention will be considered complete. W/I the 3 month engagement period, pts will receive up to 6 contacts from the Pt Navigator following referral from primary care provider. Consistent with recommended pt navigation practice, the navigator will provide feedback to primary care provider regarding cessation services that the pts are receiving.</description>
    <arm_group_label>minority smokers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will also be recruited from Heritage Health Center, located at 1727 Amsterdam&#xD;
        Ave, which serves a large proportion to low income, minority patients in Harlem, New York.&#xD;
        Also, from the Ralph Lauren Center for Cancer Care and Cancer Prevention (RLCCCP), a&#xD;
        community based Center for the prevention, diagnosis, and treatment of cancer located at&#xD;
        1919 Madison Avenue.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Self-reported current daily smoker, as verified with a portable alveolar carbon&#xD;
             monoxide (CO) analyzer (24 hour point prevalence); CO levels ≥ 8 ppm.&#xD;
&#xD;
          -  English and/or Spanish-speaking&#xD;
&#xD;
          -  Referred to the navigation program by their primary care clinician&#xD;
&#xD;
          -  At baseline, participants report at least thinking about quitting (i.e., Contemplation&#xD;
             or Preparation stages of readiness to quit).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious, untreated psychiatric illness (e.g., schizophrenia,) or active substance&#xD;
             abuse likely to preclude adherence to the protocol&#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>Jamie Ostroff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heritage Health Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ralph Lauren Center for Cancer Care and Prevention</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan-Kettering Cancer Center</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Navigation</keyword>
  <keyword>Tobacco dependent</keyword>
  <keyword>smoking</keyword>
  <keyword>Cessation</keyword>
  <keyword>11-028</keyword>
  <!-- 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/NCT01678118
org study id: 11-028
nct id: NCT01678118
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Patient navigators have been shown to assist people seeking cancer screening and other
      medical services. The purpose of this study is to see whether a patient navigator can link
      smokers to available community resources shown to help smokers quit smoking.
observational model: Case-Only
time perspective: Retrospective
measure: patient navigation (TPN) feasibility
time frame: 1 year
description: To evaluate the study's potential in terms of its reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of the intervention, tobacco-dependent patients will be asked to complete an intake interview and a telephone follow-up interview (at 3 to 6 months post-intervention).
arm group label: minority smokers
description: A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.
intervention type: Behavioral
intervention name: Patient Navigator
description: The pt navigator will phone (email, text, or other preferred method of contact) pts prior to the date of previously set individual goals (e.g. going to an appt, getting their cessation medications filled, etc) as a reminder & to discuss barriers such as finances, transportation or ambivalent motivation. In this manner, pts receive navigation services tailored to their individual needs & barriers. Once pts are connected with a cessation service (defined as either using cessation medication or at least 1 contact with a Quitline or community-based cessation counselor)or provider-prescribed cessation medication usage, continues the navigation intervention will be considered complete. W/I the 3 month engagement period, pts will receive up to 6 contacts from the Pt Navigator following referral from primary care provider. Consistent with recommended pt navigation practice, the navigator will provide feedback to primary care provider regarding cessation services that the pts are receiving.
arm group label: minority smokers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jamie Ostroff, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan-Kettering Cancer Center
responsible party type: Sponsor