<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/NCT02194959</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 07-0594</org_study_id>
    <secondary_id>5R25CA132692-05</secondary_id>
    <nct_id>NCT02194959</nct_id>
  </id_info>
  <brief_title>Peer Patient Navigation for Colon Cancer Screening</brief_title>
  <official_title>Training African American Peers as Patient Navigators for Colon Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer health disparities related to race and ethnicity are among the most serious problems&#xD;
      facing the US health care system. A recent institute of medicine report stated that such&#xD;
      disparities are seen at every level of health care, from prevention to treatment and&#xD;
      follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among&#xD;
      African Americans. According to the American cancer society, African Americans have the&#xD;
      highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and&#xD;
      mortality are 15% and 43% higher among African Americans than whites, respectively. These&#xD;
      disparities could be effectively reduced through greater African American participation in&#xD;
      CRC screening and early detection. More importantly, due to the preponderance of CRC in&#xD;
      African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to&#xD;
      colonoscopy among African Americans will save lives. Although there is clear evidence that&#xD;
      providing patients with someone to help them manage/navigate the health care system (i.e.,&#xD;
      patient navigation (PN)) is effective in helping them to complete cancer screening, very few&#xD;
      hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to&#xD;
      provide PN for patients for whom colonoscopy is recommended, in large part because of the&#xD;
      costs associated with professional-led PN. This project seeks to address this serious public&#xD;
      health problem by investigating the success of training African Americans who have undergone&#xD;
      colonoscopy to serve as volunteer peer patient navigators to encourage others from their&#xD;
      community to complete CRC screening via colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of the study was to reduce CRC morbidity and mortality by increasing African&#xD;
      American participation in colonoscopy. This was done by development and implementation of a&#xD;
      training program for Peer Patient Navigation (PPN) to increase participation of African&#xD;
      Americans in colonoscopy.&#xD;
&#xD;
      The primary care physician referred all participants and introduced the study to the patient.&#xD;
      The physician will then introduced the patient to the Research Assistant/Recruiter&#xD;
      immediately following the medical visit during which a CRC screening colonoscopy was&#xD;
      recommended. The Research Assistant/Recruiter reviewed the study and asked potential&#xD;
      participants if they were interested; if so, the candidate's eligibility was determined. If&#xD;
      these criteria were met and the patient wanted to be in the study, informed consent and HIPAA&#xD;
      was reviewed and obtained. If the patient wanted to think about his/her decision, informed&#xD;
      consent was obtained at a later date.&#xD;
&#xD;
      Patients were referred and scheduled for screening colonoscopy as part of standard of care.&#xD;
      Both groups received 3 intervention phone calls from their assigned navigators, 1) to&#xD;
      schedule the colonoscopy, 2) a call 2 weeks before the procedure and, 3) a third call three&#xD;
      days before the procedure.&#xD;
&#xD;
      For research purposes, participants were randomized to one of two kinds of patient&#xD;
      navigation:&#xD;
&#xD;
        1. Standard patient navigation receiving care that they would normally receive if they were&#xD;
           not participating in the study with navigation from the GI staff, and three phone calls&#xD;
           involved scheduling and reminding the participant about their colonoscopy appointment.&#xD;
&#xD;
        2. Peer Patient Navigation (PPN): Participants were assisted by African American peers who&#xD;
           have undergone colonoscopy, and were able to discuss, first-hand, their personal&#xD;
           experience undergoing colonoscopy and describe how they coped effectively with the&#xD;
           procedure.&#xD;
&#xD;
      PPN's underwent three months of training supervised by study investigators. Multiple modes of&#xD;
      training were used (didactic discussion, observation, role-playing, one-on-one sessions,&#xD;
      ongoing feedback, rehearsal, supervision via review of audio-tape recording or PPNs and a&#xD;
      take-home training manual).&#xD;
&#xD;
      A medical chart review was completed after the colonoscopy for all patients to assess&#xD;
      completion of the examination as well as prep quality and any findings where additional&#xD;
      clinical follow-up was required. Colonoscopy results were also collected to assess quality of&#xD;
      care and measure the effectiveness of PPN navigations compared to standard of care,&#xD;
      particularly potential differences based on study group, i.e., compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonoscopy completion</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Screening Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Peer PN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A scheduling phone call will be made to all patients within 14 days of their initial referral to the study. Following the scheduling of their appointment, each patient will be mailed an informational pamphlet with written instructions for the colonoscopy once they have scheduled the procedure. The first reminder PPN phone call will be made two weeks before a patient's scheduled colonoscopy. The second reminder PPN call will be made three days before the scheduled colonoscopy. For all calls, at least three attempts (at different times of the day and different days of the week) will be made to reach patients. All telephone calls will be audio-recorded to facilitate fidelity monitoring. All colonoscopy appointments will be made within the Division of Gastroenterology at each of the hospital sites. The Project Coordinator will be responsible for confirming completion (and no-shows) for all colonoscopy appointments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pro PN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to standard patient navigation received care that they would normally receive if they were not participating in the study with navigation from the GI staff, and three phone calls that involved scheduling and reminding the participant about their colonoscopy appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer PN</intervention_name>
    <description>Navigation by Peer Patient Navigators</description>
    <arm_group_label>Peer PN</arm_group_label>
    <other_name>Peer Patient Navigation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pro PN</intervention_name>
    <description>Navigation by Standard Hospital Navigators</description>
    <arm_group_label>Pro PN</arm_group_label>
    <other_name>Standard Patient Navigation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be self-identified as African-American&#xD;
&#xD;
          -  Referral from a primary care physician for colonoscopy&#xD;
&#xD;
          -  Agree to undergo colonoscopy at a participating hospital&#xD;
&#xD;
          -  Be at least 50 years of age or older&#xD;
&#xD;
          -  Have telephone service&#xD;
&#xD;
          -  Be able to provide informed consent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal or family history (1st degree relative) of colon cancer&#xD;
&#xD;
          -  Personal history of any chronic GI disorder (i.e., irritable bowel syndrome, colitis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lina Jandorf, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sly JR, Jandorf L, Dhulkifl R, Hall D, Edwards T, Goodman AJ, Maysonet E, Azeez S. Challenges to replicating evidence-based research in real-world settings: training African-American peers as patient navigators for colon cancer screening. J Cancer Educ. 2012 Dec;27(4):680-6. doi: 10.1007/s13187-012-0395-3.</citation>
    <PMID>22791543</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Navigation</keyword>
  <keyword>Screening Colonoscopy</keyword>
  <keyword>Colorectal Cancer Screening</keyword>
  <keyword>African Americans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</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/NCT02194959
org study id: GCO 07-0594
secondary id: 5R25CA132692-05
nct id: NCT02194959
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Cancer health disparities related to race and ethnicity are among the most serious problems
      facing the US health care system. A recent institute of medicine report stated that such
      disparities are seen at every level of health care, from prevention to treatment and
      follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among
      African Americans. According to the American cancer society, African Americans have the
      highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and
      mortality are 15% and 43% higher among African Americans than whites, respectively. These
      disparities could be effectively reduced through greater African American participation in
      CRC screening and early detection. More importantly, due to the preponderance of CRC in
      African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to
      colonoscopy among African Americans will save lives. Although there is clear evidence that
      providing patients with someone to help them manage/navigate the health care system (i.e.,
      patient navigation (PN)) is effective in helping them to complete cancer screening, very few
      hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to
      provide PN for patients for whom colonoscopy is recommended, in large part because of the
      costs associated with professional-led PN. This project seeks to address this serious public
      health problem by investigating the success of training African Americans who have undergone
      colonoscopy to serve as volunteer peer patient navigators to encourage others from their
      community to complete CRC screening via colonoscopy.
The overall goal of the study was to reduce CRC morbidity and mortality by increasing African
      American participation in colonoscopy. This was done by development and implementation of a
      training program for Peer Patient Navigation (PPN) to increase participation of African
      Americans in colonoscopy.

      The primary care physician referred all participants and introduced the study to the patient.
      The physician will then introduced the patient to the Research Assistant/Recruiter
      immediately following the medical visit during which a CRC screening colonoscopy was
      recommended. The Research Assistant/Recruiter reviewed the study and asked potential
      participants if they were interested; if so, the candidate's eligibility was determined. If
      these criteria were met and the patient wanted to be in the study, informed consent and HIPAA
      was reviewed and obtained. If the patient wanted to think about his/her decision, informed
      consent was obtained at a later date.

      Patients were referred and scheduled for screening colonoscopy as part of standard of care.
      Both groups received 3 intervention phone calls from their assigned navigators, 1) to
      schedule the colonoscopy, 2) a call 2 weeks before the procedure and, 3) a third call three
      days before the procedure.

      For research purposes, participants were randomized to one of two kinds of patient
      navigation:

        1. Standard patient navigation receiving care that they would normally receive if they were
           not participating in the study with navigation from the GI staff, and three phone calls
           involved scheduling and reminding the participant about their colonoscopy appointment.

        2. Peer Patient Navigation (PPN): Participants were assisted by African American peers who
           have undergone colonoscopy, and were able to discuss, first-hand, their personal
           experience undergoing colonoscopy and describe how they coped effectively with the
           procedure.

      PPN's underwent three months of training supervised by study investigators. Multiple modes of
      training were used (didactic discussion, observation, role-playing, one-on-one sessions,
      ongoing feedback, rehearsal, supervision via review of audio-tape recording or PPNs and a
      take-home training manual).

      A medical chart review was completed after the colonoscopy for all patients to assess
      completion of the examination as well as prep quality and any findings where additional
      clinical follow-up was required. Colonoscopy results were also collected to assess quality of
      care and measure the effectiveness of PPN navigations compared to standard of care,
      particularly potential differences based on study group, i.e., compliance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Colonoscopy completion
time frame: up to 6 months
arm group label: Peer PN
arm group type: Experimental
description: A scheduling phone call will be made to all patients within 14 days of their initial referral to the study. Following the scheduling of their appointment, each patient will be mailed an informational pamphlet with written instructions for the colonoscopy once they have scheduled the procedure. The first reminder PPN phone call will be made two weeks before a patient's scheduled colonoscopy. The second reminder PPN call will be made three days before the scheduled colonoscopy. For all calls, at least three attempts (at different times of the day and different days of the week) will be made to reach patients. All telephone calls will be audio-recorded to facilitate fidelity monitoring. All colonoscopy appointments will be made within the Division of Gastroenterology at each of the hospital sites. The Project Coordinator will be responsible for confirming completion (and no-shows) for all colonoscopy appointments.
arm group label: Pro PN
arm group type: Active Comparator
description: Participants randomized to standard patient navigation received care that they would normally receive if they were not participating in the study with navigation from the GI staff, and three phone calls that involved scheduling and reminding the participant about their colonoscopy appointment.
intervention type: Behavioral
intervention name: Peer PN
description: Navigation by Peer Patient Navigators
arm group label: Peer PN
other name: Peer Patient Navigation
intervention type: Behavioral
intervention name: Pro PN
description: Navigation by Standard Hospital Navigators
arm group label: Pro PN
other name: Standard Patient Navigation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lina Jandorf, MA
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
citation: Sly JR, Jandorf L, Dhulkifl R, Hall D, Edwards T, Goodman AJ, Maysonet E, Azeez S. Challenges to replicating evidence-based research in real-world settings: training African-American peers as patient navigators for colon cancer screening. J Cancer Educ. 2012 Dec;27(4):680-6. doi: 10.1007/s13187-012-0395-3.
PMID: 22791543
responsible party type: Sponsor
mesh term: Colonic Neoplasms