Optimizing Navigation to Successful Colorectal Cancer Screening

NCT ID: NCT02192034

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Navigation

Intervention Type BEHAVIORAL

Control

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

Group Type PLACEBO_COMPARATOR

Navigation

Intervention Type BEHAVIORAL

Interventions

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Navigation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua E Melson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ACS255086

Identifier Type: -

Identifier Source: org_study_id

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