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Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder

Primary Purpose

ColoRectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient navigation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for ColoRectal Cancer Screening

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months)
  • receive care at MGH Charlestown
  • have documented history of MH or SUD in electronic medical record

Exclusion Criteria:

  • subsequently identified as having died prior to study intervention
  • patients with total colectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    patient navigation

    usual care

    Arm 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.

    patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.

    Outcomes

    Primary Outcome Measures

    Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
    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.
    Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
    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.

    Secondary Outcome Measures

    As-treated primary outcomes among intervention patients contacted by patient navigator.
    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
    Number of cancers (stage) found in the intervention and control group during the study period
    Number of polys found in intervention polyps (histology)

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    March 20, 2018
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03244787
    Brief Title
    Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
    Official Title
    Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ColoRectal Cancer Screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    380 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patient navigation
    Arm Type
    Experimental
    Arm 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 Title
    usual care
    Arm Type
    No Intervention
    Arm 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(s)
    patient navigation
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
    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.
    Time Frame
    6 months
    Title
    Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    As-treated primary outcomes among intervention patients contacted by patient navigator.
    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
    Time Frame
    1 year
    Title
    Number of cancers (stage) found in the intervention and control group during the study period
    Time Frame
    1 year
    Title
    Number of polys found in intervention polyps (histology)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months) receive care at MGH Charlestown have documented history of MH or SUD in electronic medical record Exclusion Criteria: subsequently identified as having died prior to study intervention patients with total colectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanja Percac Lima, MD
    Organizational Affiliation
    MGH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder

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