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Optimizing Navigation to Successful Colorectal Cancer Screening

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigation
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring Colonoscopy, Colon cancer, screening, navigation

Eligibility Criteria

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

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Navigation Group

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Navigation role in colorectal cancer screening
Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2014
Last Updated
October 26, 2015
Sponsor
Rush University Medical Center
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02192034
Brief Title
Optimizing Navigation to Successful Colorectal Cancer Screening
Official Title
Optimizing Navigation to Successful Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colonoscopy, Colon cancer, screening, navigation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group will receive only clinic instructions without intervention from the patient navigator.
Intervention Type
Behavioral
Intervention Name(s)
Navigation
Primary Outcome Measure Information:
Title
Navigation role in colorectal cancer screening
Description
Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation.
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua E Melson, MD, MPH
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Optimizing Navigation to Successful Colorectal Cancer Screening

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