CClinicalTrials.gg
CompletedNCT02192034Updated Oct 28, 2015

Optimizing Navigation to Successful Colorectal Cancer Screening

An interventional study of Navigation in Colorectal Cancer Screening, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-28.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

Colorectal cancer is the second leading cause of death from cancer in the United States. Two major barriers to successful colorectal cancer screening are appointment keeping and proper bowel preparation. The purpose of this study is to test the efficacy of a patient navigation program to increase colorectal cancer screening at Rush University Medical Center. The investigators hypothesize that colorectal cancer screening will be improved for subjects who utilize a patient navigator.

02

Conditions studied

  • Colorectal Cancer Screening

Keywords

  • Colonoscopy
  • Colon cancer
  • screening
  • navigation
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 156 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary care physician
  • Age 50 or greater or 40 or greater with family history of colorectal cancer in first degree relative
  • Average risk for screening as defined as absence of symptomatic abdominal pain and active GI bleeding

Exclusion criteria

Exclusion Criteria:

  • Age > 75 years old
  • Congestive Heart Failure
  • Chronic Obstructive Pulmonary Disease
  • Myocardial Infarction
  • Weight greater than 350 pounds
  • Anticoagulation
  • Inability to speak English
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    Navigation Group

    This group will receive standard clinic instructions for the colonoscopy and two additional phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure.

    Behavioral: Navigation

  • Placebo comparator
    Control

    This group will receive only clinic instructions without intervention from the patient navigator.

    Behavioral: Navigation

Interventions

  • BehavioralNavigation
06

What researchers measure

Primary outcomes

  1. Navigation role in colorectal cancer screening

    Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.

    Time frame: Up to 90 days

07

Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02192034
Lead sponsor
Rush University Medical Center
Collaborators
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
Jul 16, 2014
Start date
Mar 2013
Primary completion
Apr 2014
Completion
Jun 2014
Last update
Oct 28, 2015

Study contacts

Joshua E Melson, MD, MPH
principal investigator · Rush University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion