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Optimizing Navigation to Successful Colorectal Cancer Screening

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ClinicalTrials.gov Identifier: NCT02192034
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Behavioral: Navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Optimizing Navigation to Successful Colorectal Cancer Screening
Study Start Date : March 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Navigation role in colorectal cancer screening [ Time Frame: Up to 90 days ]
    Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192034


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Joshua E Melson, MD, MPH Rush University Medical Center

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02192034     History of Changes
Other Study ID Numbers: ACS255086
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Rush University Medical Center:
Colonoscopy
Colon cancer
screening
navigation

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases