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Community Engaged Colon Cancer Screening Patient Navigator Program

Primary Purpose

ColoRectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening patient navigation
Non-Navigated
Sponsored by
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for ColoRectal Cancer focused on measuring community engagement, navigation, cancer screening

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Insurance, no history of colon cancer,

Exclusion Criteria:

  • No experience of relevant GI symptoms

Sites / Locations

  • Univeristy of Nevada, Reno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navigated: Screening patient navigation

Non-Navigated

Arm Description

Clinic patients who received navigation

Randomly matched sample of non-navigated clinic patients

Outcomes

Primary Outcome Measures

Colonoscopy completion

Secondary Outcome Measures

Full Information

First Posted
January 21, 2017
Last Updated
January 21, 2017
Sponsor
University of Nevada, Reno
Collaborators
National Institutes of Health (NIH), University of California, Davis, National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03031171
Brief Title
Community Engaged Colon Cancer Screening Patient Navigator Program
Official Title
Community Engaged Colon Cancer Screening Patient Navigator Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Reno
Collaborators
National Institutes of Health (NIH), University of California, Davis, National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ColoRectal Cancer
Keywords
community engagement, navigation, cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigated: Screening patient navigation
Arm Type
Experimental
Arm Description
Clinic patients who received navigation
Arm Title
Non-Navigated
Arm Type
Active Comparator
Arm Description
Randomly matched sample of non-navigated clinic patients
Intervention Type
Behavioral
Intervention Name(s)
Screening patient navigation
Intervention Description
The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.
Intervention Type
Behavioral
Intervention Name(s)
Non-Navigated
Intervention Description
Randomly matched sample of non-navigated clinic patients
Primary Outcome Measure Information:
Title
Colonoscopy completion
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Insurance, no history of colon cancer, Exclusion Criteria: No experience of relevant GI symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Devereux, PhD, MPH
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Community Engaged Colon Cancer Screening Patient Navigator Program

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