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OpenTrials
Completed

NCT Number: NCT03244787

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

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.

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Key information

Conditions

Colorectal Cancer Screening

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Behavioral

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 outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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 outcomes

  1. As-treated primary outcomes among intervention patients contacted by patient navigator.

    Time frame: 1 year

    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

  2. Number of cancers (stage) found in the intervention and control group during the study period

    Time frame: 1 year

  3. Number of polys found in intervention polyps (histology)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2017
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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