<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/NCT02226107</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 11-1374</org_study_id>
    <nct_id>NCT02226107</nct_id>
  </id_info>
  <brief_title>Latino Peers as Patient Navigators for Colon Cancer Screening</brief_title>
  <official_title>Training Latinos as Peer 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>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Disparities among racial and ethnic minorities remain prevalent despite advances in medical&#xD;
      science that make thes early detection and prevention of colorectal cancer a possibility for&#xD;
      all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented&#xD;
      through screening. Unfortunately, among Latinos, colorectal cancer is the second leading&#xD;
      cause of cancer death. This rate is influenced by the fact that Latinos have the lowest rates&#xD;
      of colorectal cancer screening compared to other US racial groups. Moreover, Latinos are more&#xD;
      likely than whites to be diagnosed with advanced-stage colorectal cancer, when treatment&#xD;
      options are more limited. Lay health worker interventions for breast and cervical cancer&#xD;
      education and screening have demonstrated success in increasing both knowledge and screening&#xD;
      rates among racial and ethnic minorities. Additionally, our research has also shown success&#xD;
      in training African Americans as peer navigators to increase colorectal cancer screening. Few&#xD;
      lay health interventions, however, have been designed specifically for colorectal cancer&#xD;
      screening among Latinos. Thus, the purpose of this study is to expand peer navigation for&#xD;
      colorectal cancer screening to Latinos and increase their participation in screening by&#xD;
      training Latinos, who have had a colonoscopy, to help navigate other Latinos through the&#xD;
      colonoscopy screening procedure.&#xD;
&#xD;
      This study will focus on expanding the work of our research group by training Latino peers,&#xD;
      who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy&#xD;
      screening completion to navigate Latino patients for screening. First, a training manual will&#xD;
      be developed which will be culturally specific to Latinos. Feedback and input from community&#xD;
      members will guide the development of the manual and training program. Second, the training&#xD;
      program will be carried out with six bilingual Latino peers, who will be taught to master the&#xD;
      core skills of patient navigation for screening colonoscopy. Finally, we will gather&#xD;
      preliminary information about the trained peers' ability to successfully navigate patients&#xD;
      for colonoscopy screening. If successful, this training program has the potential to increase&#xD;
      colonoscopy screening rates of Latinos and will be critical to the development of future&#xD;
      large-scale in interventions aimed at reducing advanced stage diagnosis of colorectal cancer&#xD;
      and ultimately colorectal cancer deaths among Latinos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are being referred and scheduled for screening and diagnostic colonoscopy as part of&#xD;
      standard of care.&#xD;
&#xD;
      For research purposes, participants will be randomized to one of two kinds of patient&#xD;
      navigation:&#xD;
&#xD;
        1. Standard patient navigation (Pro-PN) receiving care that they would normally receive if&#xD;
           they were not participating in the study with patient navigation from the primary&#xD;
           mentor's staff.&#xD;
&#xD;
        2. Peer Patient Navigation (Peer-PN): Participants will be assisted by Latino/Hispanic&#xD;
           peers who have undergone colonoscopy, and are able to discuss, first-hand, their&#xD;
           personal experience undergoing colonoscopy and describe how they coped effectively with&#xD;
           the procedure. Medical advice will not be given.&#xD;
&#xD;
      Both groups will receive 3 intervention phone calls from their assigned navigators: 1) to&#xD;
      schedule the colonoscopy 2) a reminder call two weeks before the procedure and 3) a reminder&#xD;
      call three days before the procedure. PPN's will undergo three months of training supervised&#xD;
      by Dr. Sly (who will be mentored/supervised by Dr. Itzkowitz and Professor Jandorf). Multiple&#xD;
      modes of training will be used (didactic discussion, observation, role-playing, one-on-one&#xD;
      sessions, ongoing feedback, rehearsal, supervision (by study investigator and mentors) via&#xD;
      review of audio-tape recordings of Latino peers' navigation phone calls to the participants&#xD;
      and a take-home training manual).&#xD;
&#xD;
      Patients receiving standard patient navigation will receive the care and assessments that&#xD;
      they would normally receive if they were not participating in a study. Patients in the&#xD;
      Peer-PN group will be guided through the colonoscopy process by a Latino/Hispanic peer who&#xD;
      has undergone colonoscopy and will provide the personal prospective of how they coped with&#xD;
      the procedure.&#xD;
&#xD;
      At some point before the colonoscopy procedure, patients will receive a phone call, during&#xD;
      which a research assistant will administer a questionnaire in the form of an interview. Study&#xD;
      staff will assess health care behavior, fear of colonoscopy and concerns about CRC screening,&#xD;
      medical mistrust, interpersonal communication, social influence, and self-efficacy. A medical&#xD;
      chart review will also be 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 will also be collected to assess quality&#xD;
      of care and measure the efficacy of Peer-PN navigations compared to standard navigation,&#xD;
      particularly potential differences based on study group, i.e., compliance. No other&#xD;
      information outside of standard of care will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonoscopy Completion</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Participants will be given up to four months (including re-scheduling) to complete their colonoscopy after an initial appointment is scheduled.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Peer-PN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peer Patient Navigation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pro-PN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Professional Patient Navigation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer-PN</intervention_name>
    <description>Participants in the peer-PN group will also receive two navigation telephone calls: 1) to schedule the colonoscopy, and 2) a reminder call one week before the procedure. It is expected that these phone calls will be shortly longer than the Pro-PN calls by 5-7 minutes because of the additional focus on culture and peer modeling. Peers will remind the patient about the procedure and address concerns, but will provide culturally specific, identity-based navigation, in which they will speak specifically about Latino rates of CRC screening while also modeling self-efficacy by describing what their experience was like before, during and after the colonoscopy procedure.</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>Participants in the standard navigation group receive two phone calls: 1) to schedule the colonoscopy and 2) a reminder call one week before the procedure. The phone calls will each last approximately 15 minutes. During the second phone call, the patient will be reminded about the procedure and any concerns they may have will be addressed. Professional navigators will also be advised to not disclose their race or ethnicity or to discuss specific issues related to Latinos and CRC screening.</description>
    <arm_group_label>Pro-PN</arm_group_label>
    <other_name>Professional Patient Navigation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred for a screening or diagnostic colonoscopy by a primary care physician&#xD;
&#xD;
          -  50 years or older&#xD;
&#xD;
          -  Identify as Hispanic or Latino&#xD;
&#xD;
          -  Provide informed consent in Spanish or English&#xD;
&#xD;
          -  Have access to a working telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of colon cancer&#xD;
&#xD;
          -  Personal history of any chronic gastrointestinal disorder (i.e., colitis, irritable&#xD;
             bowel syndrome)&#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>Jamilia Sly, PhD</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>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 29, 2015</last_update_submitted>
  <last_update_submitted_qc>September 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lay health worker</keyword>
  <keyword>Patient navigation</keyword>
  <keyword>Screening colonoscopy</keyword>
  <keyword>Colon cancer</keyword>
  <keyword>Training</keyword>
  <keyword>Hispanic</keyword>
  <keyword>Latino</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/NCT02226107
org study id: GCO 11-1374
nct id: NCT02226107
lead sponsor: 
has dmc: No
Disparities among racial and ethnic minorities remain prevalent despite advances in medical
      science that make thes early detection and prevention of colorectal cancer a possibility for
      all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented
      through screening. Unfortunately, among Latinos, colorectal cancer is the second leading
      cause of cancer death. This rate is influenced by the fact that Latinos have the lowest rates
      of colorectal cancer screening compared to other US racial groups. Moreover, Latinos are more
      likely than whites to be diagnosed with advanced-stage colorectal cancer, when treatment
      options are more limited. Lay health worker interventions for breast and cervical cancer
      education and screening have demonstrated success in increasing both knowledge and screening
      rates among racial and ethnic minorities. Additionally, our research has also shown success
      in training African Americans as peer navigators to increase colorectal cancer screening. Few
      lay health interventions, however, have been designed specifically for colorectal cancer
      screening among Latinos. Thus, the purpose of this study is to expand peer navigation for
      colorectal cancer screening to Latinos and increase their participation in screening by
      training Latinos, who have had a colonoscopy, to help navigate other Latinos through the
      colonoscopy screening procedure.

      This study will focus on expanding the work of our research group by training Latino peers,
      who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy
      screening completion to navigate Latino patients for screening. First, a training manual will
      be developed which will be culturally specific to Latinos. Feedback and input from community
      members will guide the development of the manual and training program. Second, the training
      program will be carried out with six bilingual Latino peers, who will be taught to master the
      core skills of patient navigation for screening colonoscopy. Finally, we will gather
      preliminary information about the trained peers' ability to successfully navigate patients
      for colonoscopy screening. If successful, this training program has the potential to increase
      colonoscopy screening rates of Latinos and will be critical to the development of future
      large-scale in interventions aimed at reducing advanced stage diagnosis of colorectal cancer
      and ultimately colorectal cancer deaths among Latinos.
Patients are being referred and scheduled for screening and diagnostic colonoscopy as part of
      standard of care.

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

        1. Standard patient navigation (Pro-PN) receiving care that they would normally receive if
           they were not participating in the study with patient navigation from the primary
           mentor's staff.

        2. Peer Patient Navigation (Peer-PN): Participants will be assisted by Latino/Hispanic
           peers who have undergone colonoscopy, and are able to discuss, first-hand, their
           personal experience undergoing colonoscopy and describe how they coped effectively with
           the procedure. Medical advice will not be given.

      Both groups will receive 3 intervention phone calls from their assigned navigators: 1) to
      schedule the colonoscopy 2) a reminder call two weeks before the procedure and 3) a reminder
      call three days before the procedure. PPN's will undergo three months of training supervised
      by Dr. Sly (who will be mentored/supervised by Dr. Itzkowitz and Professor Jandorf). Multiple
      modes of training will be used (didactic discussion, observation, role-playing, one-on-one
      sessions, ongoing feedback, rehearsal, supervision (by study investigator and mentors) via
      review of audio-tape recordings of Latino peers' navigation phone calls to the participants
      and a take-home training manual).

      Patients receiving standard patient navigation will receive the care and assessments that
      they would normally receive if they were not participating in a study. Patients in the
      Peer-PN group will be guided through the colonoscopy process by a Latino/Hispanic peer who
      has undergone colonoscopy and will provide the personal prospective of how they coped with
      the procedure.

      At some point before the colonoscopy procedure, patients will receive a phone call, during
      which a research assistant will administer a questionnaire in the form of an interview. Study
      staff will assess health care behavior, fear of colonoscopy and concerns about CRC screening,
      medical mistrust, interpersonal communication, social influence, and self-efficacy. A medical
      chart review will also be 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 will also be collected to assess quality
      of care and measure the efficacy of Peer-PN navigations compared to standard navigation,
      particularly potential differences based on study group, i.e., compliance. No other
      information outside of standard of care will be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Colonoscopy Completion
time frame: up to 4 months
description: Participants will be given up to four months (including re-scheduling) to complete their colonoscopy after an initial appointment is scheduled.
arm group label: Peer-PN
arm group type: Experimental
description: Peer Patient Navigation
arm group label: Pro-PN
arm group type: Active Comparator
description: Professional Patient Navigation
intervention type: Behavioral
intervention name: Peer-PN
description: Participants in the peer-PN group will also receive two navigation telephone calls: 1) to schedule the colonoscopy, and 2) a reminder call one week before the procedure. It is expected that these phone calls will be shortly longer than the Pro-PN calls by 5-7 minutes because of the additional focus on culture and peer modeling. Peers will remind the patient about the procedure and address concerns, but will provide culturally specific, identity-based navigation, in which they will speak specifically about Latino rates of CRC screening while also modeling self-efficacy by describing what their experience was like before, during and after the colonoscopy procedure.
arm group label: Peer-PN
other name: Peer Patient Navigation
intervention type: Behavioral
intervention name: Pro-PN
description: Participants in the standard navigation group receive two phone calls: 1) to schedule the colonoscopy and 2) a reminder call one week before the procedure. The phone calls will each last approximately 15 minutes. During the second phone call, the patient will be reminded about the procedure and any concerns they may have will be addressed. Professional navigators will also be advised to not disclose their race or ethnicity or to discuss specific issues related to Latinos and CRC screening.
arm group label: Pro-PN
other name: Professional Patient Navigation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jamilia Sly, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms