Community Engaged Colon Cancer Screening Patient Navigator Program

ColoRectal Cancer Clinical Trial

Official title:

Community Engaged Colon Cancer Screening Patient Navigator Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031171
• Other study ID #: SB09/10-034
• Secondary ID: 8P20GM103440-11
• Status: Completed
• Phase: N/A
• First received: January 21, 2017
• Last updated: January 21, 2017
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2016
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Insurance, no history of colon cancer,

Exclusion Criteria:

• No experience of relevant GI symptoms

Related Conditions & MeSH terms

• Colonic Neoplasms
• ColoRectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Screening patient navigation
The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.
• Non-Navigated
Randomly matched sample of non-navigated clinic patients

Locations

Country	Name	City	State
United States	Univeristy of Nevada, Reno	Reno	Nevada

Sponsors (4)

Lead Sponsor	Collaborator
University of Nevada, Reno	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonoscopy completion		2 years