Optimizing Navigation to Successful Colorectal Cancer Screening
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedOctober 28, 2015
October 1, 2015
1.1 years
June 2, 2014
October 26, 2015
Conditions
Keywords
Outcome Measures
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.
Up to 90 days
Study Arms (2)
Navigation Group
EXPERIMENTALThis 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.
Control
PLACEBO COMPARATORThis group will receive only clinic instructions without intervention from the patient navigator.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \> 75 years old
- Congestive Heart Failure
- Chronic Obstructive Pulmonary Disease
- Myocardial Infarction
- Weight greater than 350 pounds
- Anticoagulation
- Inability to speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- American Cancer Society, Inc.collaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua E Melson, MD, MPH
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2014
First Posted
July 16, 2014
Study Start
March 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
October 28, 2015
Record last verified: 2015-10