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NCT02192034 Clinical Trial

Optimizing Navigation to Successful Colorectal Cancer Screening

Colorectal Cancer Screening Clinical Trial

Official title:
Optimizing Navigation to Successful Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02192034
Other study ID # ACS255086
Secondary ID
Status Completed
Phase N/A
First received June 2, 2014
Last updated October 26, 2015
Start date March 2013
Est. completion date June 2014

Study information
Verified date October 2015
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Behavioral:
• Navigation

Locations
Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Rush University Medical Center American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Navigation role in colorectal cancer screening Primary endpoint will be the role of navigation to obtain colonoscopy attendance with adequate colonoscopy preparation. Up to 90 days No
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