<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/NCT02989974</url>
  </required_header>
  <id_info>
    <org_study_id>17-BS-01</org_study_id>
    <secondary_id>16-0813</secondary_id>
    <nct_id>NCT02989974</nct_id>
  </id_info>
  <brief_title>Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program</brief_title>
  <acronym>KYLEADS-SC</acronym>
  <official_title>Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jamie Studts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lung Cancer Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</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>
      The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop,&#xD;
      administer and evaluate the impact of a comprehensive psychosocial survivorship care program&#xD;
      for individuals diagnosed with lung cancer and their caregivers to improve lung cancer&#xD;
      survivorship and delivery of high-quality lung cancer care. The investigators hypothesize&#xD;
      that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved&#xD;
      quality of life, better symptom control, increased tobacco treatment, and reduced distress&#xD;
      among lung cancer survivors and their caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a single-arm clinical trial, or a prospective cohort design, where a&#xD;
      longitudinal series of data will be collected from participants. Participants will be&#xD;
      consented and asked to complete a baseline questionnaire (PRE) which includes topics&#xD;
      measuring quality of life, distress, symptom management, social support, healthy behaviors,&#xD;
      demographics and health history. Two similar questionnaires will be administered after&#xD;
      exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form&#xD;
      requests permission from survivors to collect clinical data from medical records and the&#xD;
      Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will&#xD;
      enroll 300 participants, with an estimate of approximately 30 participants enrolled at each&#xD;
      site. However, if a participating site enrolls 30 participants and the overall study accrual&#xD;
      has not yet been met, the study PI may allow that respective participating site to continue&#xD;
      to enroll participants. Study accrual is competitive across participating sites until the&#xD;
      overall study accrual has been met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">April 24, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Participating survivor intervention acceptability (1A)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Participating survivor intervention satisfaction (1B)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Participating survivor intervention uptake (1C)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Intervention Feasibility A: Intervention accrual rate</measure>
    <time_frame>6 months post-baseline</time_frame>
    <description>Intervention Feasibility - study accrual rate (2A)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey</measure>
    <time_frame>6 months post-baseline</time_frame>
    <description>Intervention Feasibility - SC Specialist ratings (2B)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Feasibility - Survivor survey completion rate (3A)</description>
  </other_outcome>
  <other_outcome>
    <measure>Tertiary Study Feasibility B: Study drop-out rate among participating survivors</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Feasibility - Survivor drop-out rate (3B)</description>
  </other_outcome>
  <other_outcome>
    <measure>Tertiary Study Feasibility C: Rate of missing survivor/caregiver data</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Feasibility - Rate of missing survivor/caregiver data (3C)</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Study Efficacy A1: Survivor quality of life</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1)</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Study Efficacy B1: Survivor lung cancer specific quality of life</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1)</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Study Efficacy A2: Caregiver quality of life</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2)</description>
  </other_outcome>
  <other_outcome>
    <measure>Additional Study Efficacy B2: Caregiver self-efficacy</measure>
    <time_frame>1 week post-intervention up to 1 month post-intervention</time_frame>
    <description>Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>KY LEADS Survivorship Care - Survivor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KY LEADS Survivorship Care - Caregiver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>KY LEADS Survivorship Care</intervention_name>
    <description>Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment.&#xD;
Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment</description>
    <arm_group_label>KY LEADS Survivorship Care - Caregiver</arm_group_label>
    <arm_group_label>KY LEADS Survivorship Care - Survivor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who have been diagnosed with lung cancer (survivor) or&#xD;
&#xD;
          -  Caregiver of a participating lung cancer survivor&#xD;
&#xD;
          -  Ability to read and write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with significant psychiatric disturbance that requires a higher level of&#xD;
             care&#xD;
&#xD;
          -  Individuals with substance abuse/dependence problem that require a higher level of&#xD;
             care&#xD;
&#xD;
          -  Incarcerate individuals or individuals detained within the legal system&#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 L Studts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, University of Kentucky College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kings Daughters Medical Center - Ashland</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Cancer Center - Danville</name>
      <address>
        <city>Danville</city>
        <state>Kentucky</state>
        <zip>40422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hardin Memorial Health - Elizabethtown</name>
      <address>
        <city>Elizabethtown</city>
        <state>Kentucky</state>
        <zip>42701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hazard ARH Regional Medical Center</name>
      <address>
        <city>Hazard</city>
        <state>Kentucky</state>
        <zip>41701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UofL/Brown Cancer Center - Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health - Madisonville</name>
      <address>
        <city>Madisonville</city>
        <state>Kentucky</state>
        <zip>42431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Claire Regional Medical Center - Morehead</name>
      <address>
        <city>Morehead</city>
        <state>Kentucky</state>
        <zip>40351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Owensboro Health</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Jamie Studts</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Survivorship Care</keyword>
  <keyword>Caregiving</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989974
org study id: 17-BS-01
secondary id: 16-0813
nct id: NCT02989974
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop,
      administer and evaluate the impact of a comprehensive psychosocial survivorship care program
      for individuals diagnosed with lung cancer and their caregivers to improve lung cancer
      survivorship and delivery of high-quality lung cancer care. The investigators hypothesize
      that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved
      quality of life, better symptom control, increased tobacco treatment, and reduced distress
      among lung cancer survivors and their caregivers.
The study design is a single-arm clinical trial, or a prospective cohort design, where a
      longitudinal series of data will be collected from participants. Participants will be
      consented and asked to complete a baseline questionnaire (PRE) which includes topics
      measuring quality of life, distress, symptom management, social support, healthy behaviors,
      demographics and health history. Two similar questionnaires will be administered after
      exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form
      requests permission from survivors to collect clinical data from medical records and the
      Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will
      enroll 300 participants, with an estimate of approximately 30 participants enrolled at each
      site. However, if a participating site enrolls 30 participants and the overall study accrual
      has not yet been met, the study PI may allow that respective participating site to continue
      to enroll participants. Study accrual is competitive across participating sites until the
      overall study accrual has been met.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
time frame: 1 week post-intervention up to 1 month post-intervention
description: Participating survivor intervention acceptability (1A)
measure: Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey
time frame: 1 week post-intervention up to 1 month post-intervention
description: Participating survivor intervention satisfaction (1B)
measure: Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data
time frame: 1 week post-intervention up to 1 month post-intervention
description: Participating survivor intervention uptake (1C)
measure: Secondary Intervention Feasibility A: Intervention accrual rate
time frame: 6 months post-baseline
description: Intervention Feasibility - study accrual rate (2A)
measure: Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey
time frame: 6 months post-baseline
description: Intervention Feasibility - SC Specialist ratings (2B)
measure: Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Feasibility - Survivor survey completion rate (3A)
measure: Tertiary Study Feasibility B: Study drop-out rate among participating survivors
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Feasibility - Survivor drop-out rate (3B)
measure: Tertiary Study Feasibility C: Rate of missing survivor/caregiver data
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Feasibility - Rate of missing survivor/caregiver data (3C)
measure: Additional Study Efficacy A1: Survivor quality of life
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1)
measure: Additional Study Efficacy B1: Survivor lung cancer specific quality of life
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1)
measure: Additional Study Efficacy A2: Caregiver quality of life
time frame: 1 week post-intervention up to 1 month post-intervention
description: tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2)
measure: Additional Study Efficacy B2: Caregiver self-efficacy
time frame: 1 week post-intervention up to 1 month post-intervention
description: Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2)
arm group label: KY LEADS Survivorship Care - Survivor
arm group type: Experimental
description: The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor).
arm group label: KY LEADS Survivorship Care - Caregiver
arm group type: Experimental
description: The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver)
intervention type: Behavioral
intervention name: KY LEADS Survivorship Care
description: Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment.
Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment
arm group label: KY LEADS Survivorship Care - Caregiver
arm group label: KY LEADS Survivorship Care - Survivor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jamie L Studts, PhD
role: Principal Investigator
affiliation: Professor, University of Kentucky College of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Jamie Studts
investigator title: Principal Investigator
mesh term: Lung Neoplasms
sharing ipd: No