<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/NCT01726296</url>
  </required_header>
  <id_info>
    <org_study_id>12-841</org_study_id>
    <secondary_id>NCI-2012-01717</secondary_id>
    <nct_id>NCT01726296</nct_id>
  </id_info>
  <brief_title>Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care</brief_title>
  <official_title>Adherence to NCCN Survivorship Care Guidelines in Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies adherence to survivorship care guidelines in health care&#xD;
      providers for non-small cell lung cancer or colorectal cancer survivor care. The completion&#xD;
      of an educational intervention by health care providers may increase compliance and adherence&#xD;
      to National Comprehensive Cancer Network guidelines for survivorship care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate adherence of oncology health care providers to National Comprehensive Cancer&#xD;
      Network (NCCN) guidelines for cancer survivorship care in colorectal cancer (CRC) and&#xD;
      non-small cell lung cancer (NSCLC) cancers.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To develop and assess a targeted educational initiative to improve compliance with NCCN&#xD;
      CRC and NSCLC survivorship guidelines for oncology health care providers in academic and&#xD;
      community practice.&#xD;
&#xD;
      II. To evaluate the impact of this educational initiative on documented adherence and&#xD;
      compliance with NCCN guidelines for NSCLC and CRC survivorship care by oncology health care&#xD;
      providers.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Health care providers complete an educational intervention based on NCCN guidelines in CRC&#xD;
      and NSCLC survivorship care comprising a power point presentation reviewing evidence and&#xD;
      guidelines; a USB drive of the NCCN guidelines with paper copy of pages addressing&#xD;
      survivorship care; an electronic and paper copy of a sample survivorship clinic template note&#xD;
      with prompts for addressing survivorship care components; and an electronic paper copy sample&#xD;
      survivorship care plan that can be adapted and distributed at each participating site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites</measure>
    <time_frame>Baseline and up to 6 months</time_frame>
    <description>This two-sample test of binomial proportions will have 99% power with 1% type I error.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1440</enrollment>
  <condition>Adenocarcinoma of the Lung</condition>
  <condition>Mucinous Adenocarcinoma of the Colon</condition>
  <condition>Mucinous Adenocarcinoma of the Rectum</condition>
  <condition>Signet Ring Adenocarcinoma of the Colon</condition>
  <condition>Signet Ring Adenocarcinoma of the Rectum</condition>
  <condition>Squamous Cell Lung Cancer</condition>
  <condition>Stage I Colon Cancer</condition>
  <condition>Stage I Rectal Cancer</condition>
  <condition>Stage IA Non-small Cell Lung Cancer</condition>
  <condition>Stage IB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIA Colon Cancer</condition>
  <condition>Stage IIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIA Rectal Cancer</condition>
  <condition>Stage IIB Colon Cancer</condition>
  <condition>Stage IIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIB Rectal Cancer</condition>
  <condition>Stage IIC Colon Cancer</condition>
  <condition>Stage IIC Rectal Cancer</condition>
  <condition>Stage IIIA Colon Cancer</condition>
  <condition>Stage IIIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIA Rectal Cancer</condition>
  <condition>Stage IIIB Colon Cancer</condition>
  <condition>Stage IIIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIB Rectal Cancer</condition>
  <condition>Stage IIIC Colon Cancer</condition>
  <condition>Stage IIIC Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Health services research (educational intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health care providers complete an educational intervention based on NCCN guidelines in CRC and NSCLC survivorship care comprising a power point presentation reviewing evidence and prompts for addressing survivorship care components; and an electronic paper copy sample survivorship care plan that can be adapted and distributed at each participating site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational intervention</intervention_name>
    <description>Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care</description>
    <arm_group_label>Health services research (educational intervention)</arm_group_label>
    <other_name>intervention, educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>medical chart review</intervention_name>
    <description>Complete patient medical chart audit</description>
    <arm_group_label>Health services research (educational intervention)</arm_group_label>
    <other_name>chart review</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HEALTH CARE PROVIDER INCLUSION CRITERIA:&#xD;
&#xD;
          -  Any health care provider (physician, advanced practice clinician) at a study site (Fox&#xD;
             Chase Cancer Center [FCCC] and Fox Chase Cancer Center Partners [FCCCP]) who provides&#xD;
             care for NSCLC and/or CRC survivors&#xD;
&#xD;
          -  CHART AUDIT INCLUSION CRITERIA (BASELINE):&#xD;
&#xD;
          -  Cancer Registry cases include stage I-III colon cancer (adenocarcinoma histology),&#xD;
             stage I-III rectal cancer (adenocarcinoma histology), stage I-III non-small cell lung&#xD;
             cancer (squamous or adenocarcinoma histology)&#xD;
&#xD;
          -  Patients must have completed all therapy for curative intent at least six months prior&#xD;
             to chart audit&#xD;
&#xD;
          -  Undergoing routine oncology care and surveillance at the chosen site (defined as&#xD;
             receiving follow-up care with FCCC or FCCCP site health care providers and have an&#xD;
             active medical chart)&#xD;
&#xD;
          -  No evidence of metastatic disease&#xD;
&#xD;
          -  Patients must have been seen for a visit for cancer surveillance between 2009 and 2013&#xD;
&#xD;
          -  Health care providers at the participating site must be willing and able to&#xD;
             participate in the educational initiative&#xD;
&#xD;
          -  CHART AUDIT INCLUSION CRITERIA (POST-INTERVENTION)&#xD;
&#xD;
          -  Charts eligible for audit after completion of the educational initiative will be for&#xD;
             those CRC and NSCLC survivors presenting for follow-up after the initiative has been&#xD;
             completed by site health care providers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CHART AUDIT EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Cancer Registry cases for diseases other than colon or rectal adenocarcinoma and&#xD;
             non-small cell lung cancer (squamous or adenocarcinoma histology)&#xD;
&#xD;
          -  Patients currently receiving active therapy for any cancer, including CRC or NSCLC&#xD;
&#xD;
          -  Patients who do not undergo routine oncologic care at the chosen Partners site or Fox&#xD;
             Chase Cancer Center&#xD;
&#xD;
          -  Stage IV cancer or evidence of metastatic disease at any time point&#xD;
&#xD;
          -  Patients who have not undergone a visit for cancer surveillance since 2009&#xD;
&#xD;
          -  Fox Chase Cancer Partners sites who do not agree to chart audit procedures or&#xD;
             providers are unable or unwilling to participate in the educational initiative&#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>Crystal Denlinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fox Chase Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2017</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
    <mesh_term>Adenocarcinoma, Mucinous</mesh_term>
    <mesh_term>Cystadenocarcinoma</mesh_term>
  </condition_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/NCT01726296
org study id: 12-841
secondary id: NCI-2012-01717
nct id: NCT01726296
lead sponsor: 
has dmc: No
This clinical trial studies adherence to survivorship care guidelines in health care
      providers for non-small cell lung cancer or colorectal cancer survivor care. The completion
      of an educational intervention by health care providers may increase compliance and adherence
      to National Comprehensive Cancer Network guidelines for survivorship care.
PRIMARY OBJECTIVES:

      I. To evaluate adherence of oncology health care providers to National Comprehensive Cancer
      Network (NCCN) guidelines for cancer survivorship care in colorectal cancer (CRC) and
      non-small cell lung cancer (NSCLC) cancers.

      SECONDARY OBJECTIVES:

      I. To develop and assess a targeted educational initiative to improve compliance with NCCN
      CRC and NSCLC survivorship guidelines for oncology health care providers in academic and
      community practice.

      II. To evaluate the impact of this educational initiative on documented adherence and
      compliance with NCCN guidelines for NSCLC and CRC survivorship care by oncology health care
      providers.

      OUTLINE:

      Health care providers complete an educational intervention based on NCCN guidelines in CRC
      and NSCLC survivorship care comprising a power point presentation reviewing evidence and
      guidelines; a USB drive of the NCCN guidelines with paper copy of pages addressing
      survivorship care; an electronic and paper copy of a sample survivorship clinic template note
      with prompts for addressing survivorship care components; and an electronic paper copy sample
      survivorship care plan that can be adapted and distributed at each participating site.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of eligible CRC and NSCLC survivors with medical record documentation of compliance with NCCN guidelines
time frame: Up to 6 months
description: A test of the binomial proportion will have 99% power with 1% type I error to make this distinction.
measure: Change in percentage of eligible survivors with documentation of compliance with NCCN survivorship guidelines after conducting the targeted educational initiative at participating sites
time frame: Baseline and up to 6 months
description: This two-sample test of binomial proportions will have 99% power with 1% type I error.
arm group label: Health services research (educational intervention)
arm group type: Experimental
description: Health care providers complete an educational intervention based on NCCN guidelines in CRC and NSCLC survivorship care comprising a power point presentation reviewing evidence and prompts for addressing survivorship care components; and an electronic paper copy sample survivorship care plan that can be adapted and distributed at each participating site.
intervention type: Other
intervention name: educational intervention
description: Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care
arm group label: Health services research (educational intervention)
other name: intervention, educational
intervention type: Other
intervention name: medical chart review
description: Complete patient medical chart audit
arm group label: Health services research (educational intervention)
other name: chart review
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Crystal Denlinger, MD
role: Principal Investigator
affiliation: Fox Chase Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Adenocarcinoma
mesh term: Rectal Neoplasms
mesh term: Colonic Neoplasms
mesh term: Adenocarcinoma of Lung
mesh term: Adenocarcinoma, Mucinous
mesh term: Cystadenocarcinoma