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Community Engaged Colon Cancer Screening Patient Navigator Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031171
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of California, Davis
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Nevada, Reno

Brief Summary:
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.

Condition or disease Intervention/treatment Phase
ColoRectal Cancer Behavioral: Screening patient navigation Behavioral: Non-Navigated Not Applicable

Detailed Description:
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. A well-tested behavioral change theory (the health belief model; HBM) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. Although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. In addition, there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b) the relationships among the model's constructs. A quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. A minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. The anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Community Engaged Colon Cancer Screening Patient Navigator Program
Study Start Date : April 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Navigated: Screening patient navigation
Clinic patients who received navigation
Behavioral: Screening patient navigation
The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.

Active Comparator: Non-Navigated
Randomly matched sample of non-navigated clinic patients
Behavioral: Non-Navigated
Randomly matched sample of non-navigated clinic patients




Primary Outcome Measures :
  1. Colonoscopy completion [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Insurance, no history of colon cancer,

Exclusion Criteria:

  • No experience of relevant GI symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031171


Locations
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United States, Nevada
Univeristy of Nevada, Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
University of Nevada, Reno
National Institutes of Health (NIH)
University of California, Davis
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Paul Devereux, PhD, MPH University of Nevada, Reno
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Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03031171    
Other Study ID Numbers: SB09/10-034
8P20GM103440-11 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nevada, Reno:
community engagement, navigation, cancer screening
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases