<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/NCT03244787</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001322</org_study_id>
    <nct_id>NCT03244787</nct_id>
  </id_info>
  <brief_title>Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder</brief_title>
  <official_title>Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC)&#xD;
      screening patient navigator program for patients with Mental Health (MH) and /or Substance&#xD;
      Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study&#xD;
      will involve randomly assigning eligible patients to early intervention or usual care/delayed&#xD;
      intervention groups. The investigators believe this random assignment is ethical because&#xD;
      Patient Navigation (PN) is an extremely limited resource, and all patients identified as&#xD;
      eligible could not be contacted by the navigators in a short period of time. Thus the&#xD;
      investigators will randomly assign access to PN during the study period, and then allow all&#xD;
      patients to be navigated and screened after the study period is over. As a result, all&#xD;
      eligible patients will be referred for PN, but the timing of the referral will be randomly&#xD;
      assigned.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period</measure>
    <time_frame>6 months</time_frame>
    <description>To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of colonoscopy results) we will perform EMR reviewed of trial participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period</measure>
    <time_frame>6 months</time_frame>
    <description>To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of fecal occult blood test results) we will perform EMR reviewed of trial participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>As-treated primary outcomes among intervention patients contacted by patient navigator.</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of patients in intervention and control groups who completed colorectal cancer cancer screening stratified by Mental health vs Substance use disorder, language spoken, race and age (&lt;&gt; 65 years) during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cancers (stage) found in the intervention and control group during the study period</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of polys found in intervention polyps (histology)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>ColoRectal Cancer Screening</condition>
  <arm_group>
    <arm_group_label>patient navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>patient navigation</intervention_name>
    <description>Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.</description>
    <arm_group_label>patient navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients aged 50-75 years who are not up to date on CRC screening (did not have&#xD;
             had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or&#xD;
             fecal occult blood within last 12 months)&#xD;
&#xD;
          -  receive care at MGH Charlestown&#xD;
&#xD;
          -  have documented history of MH or SUD in electronic medical record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subsequently identified as having died prior to study intervention&#xD;
&#xD;
          -  patients with total colectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanja Percac Lima, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>March 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Carolina Abuelo</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</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/NCT03244787
org study id: 2016P001322
nct id: NCT03244787
lead sponsor: 
has dmc: No
The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC)
      screening patient navigator program for patients with Mental Health (MH) and /or Substance
      Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study
      will involve randomly assigning eligible patients to early intervention or usual care/delayed
      intervention groups. The investigators believe this random assignment is ethical because
      Patient Navigation (PN) is an extremely limited resource, and all patients identified as
      eligible could not be contacted by the navigators in a short period of time. Thus the
      investigators will randomly assign access to PN during the study period, and then allow all
      patients to be navigated and screened after the study period is over. As a result, all
      eligible patients will be referred for PN, but the timing of the referral will be randomly
      assigned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
time frame: 6 months
description: To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of colonoscopy results) we will perform EMR reviewed of trial participants.
measure: Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
time frame: 6 months
description: To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of fecal occult blood test results) we will perform EMR reviewed of trial participants.
measure: As-treated primary outcomes among intervention patients contacted by patient navigator.
time frame: 1 year
description: Percentage of patients in intervention and control groups who completed colorectal cancer cancer screening stratified by Mental health vs Substance use disorder, language spoken, race and age (<> 65 years) during the study period
measure: Number of cancers (stage) found in the intervention and control group during the study period
time frame: 1 year
measure: Number of polys found in intervention polyps (histology)
time frame: 1 year
arm group label: patient navigation
arm group type: Experimental
description: PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.
arm group label: usual care
arm group type: No Intervention
description: patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.
intervention type: Behavioral
intervention name: patient navigation
description: Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.
arm group label: patient navigation
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sanja Percac Lima, MD
role: Principal Investigator
affiliation: MGH
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Carolina Abuelo
investigator title: Instructor
mesh term: Colorectal Neoplasms
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
sharing ipd: No