- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192034
Optimizing Navigation to Successful Colorectal Cancer Screening
October 26, 2015 updated by: Rush University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
|
Placebo Comparator: Control
This group will receive only clinic instructions without intervention from the patient navigator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua E Melson, MD, MPH, Rush University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
July 15, 2014
First Posted (Estimate)
July 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 28, 2015
Last Update Submitted That Met QC Criteria
October 26, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACS255086
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer Screening
-
Sunil PatelCompletedColonoscopy | Mass Screening | Colorectal Cancer ScreeningCanada
-
Memorial Sloan Kettering Cancer CenterRalph Lauren Center for Cancer Care and Prevention; North General Hospital,...Completed
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer Screening | Implementation | Colorectal Cancer ScreeningUnited States
-
Motus GI Medical Technologies LtdTerminated
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingColorectal Cancer | Gastrointestinal Microbiome | Colorectal Polyp | Mass ScreeningChina
-
Massachusetts General HospitalAgency for Healthcare Research and Quality (AHRQ)CompletedBreast Cancer Screening | Colon Cancer Screening | Prostate Cancer ScreeningUnited States
-
Clinical Directors NetworkCompletedDepression | Cervical Cancer Screening | Breast Cancer Screening | Colorectal Cancer ScreeningUnited States
-
University Paul Sabatier of ToulouseAssistance Publique Hopitaux De Marseille; Institut National de la Santé Et... and other collaboratorsActive, not recruitingColorectal Cancer ScreeningFrance
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI); The Institute for Family HealthEnrolling by invitationColorectal Cancer ScreeningUnited States
-
Florida A&M UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
Clinical Trials on Navigation
-
Tufts Medical CenterThe Leukemia and Lymphoma SocietyActive, not recruitingCancer | Financial Stress | SurvivorshipUnited States
-
Tongji HospitalGuangdong Provincial People's Hospital; Wuhan Asia Heart Hospital; Fu Wai Hospital... and other collaboratorsUnknownBradycardia | Sick Sinus Syndrome | Complete Atrioventricular Block | High Degree Second Degree Atrioventricular Block (Disorder)China
-
Samsung Medical CenterUnknown
-
University of Colorado, DenverDenver Health and Hospital Authority; Rocky Mountain Human Services; El Grupo...Completed
-
Tongji HospitalGuangdong Provincial People's Hospital; Wuhan Asia Heart Hospital; Fu Wai Hospital... and other collaboratorsUnknownBradycardia | Sick Sinus Syndrome | High Degree Second Degree Atrioventricular Block | Complete Atrioventricular BlockChina
-
Medical University of ViennaCompletedChronic Total Coronary Occlusion
-
Norwegian University of Science and TechnologySt. Olavs Hospital; SINTEF Health ResearchCompletedAtrial FibrillationNorway
-
Broncus TechnologiesHeidelberg UniversityUnknown
-
StereotaxisCompletedAtrial FibrillationUnited States, Belgium, Germany
-
Universitätsklinikum Hamburg-EppendorfUnknown