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CompletedNCT03031171Updated Jan 25, 2017

Community Engaged Colon Cancer Screening Patient Navigator Program

An interventional study of Screening patient navigation and Non-Navigated in ColoRectal Cancer, sponsored by University of Nevada, Reno. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by University of Nevada, Reno · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
415
Allocation
Non-randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • ColoRectal Cancer

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Keywords

  • community engagement, navigation, cancer screening
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 415 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

University of Nevada, Reno is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Insurance, no history of colon cancer,

Exclusion criteria

Exclusion Criteria:

  • No experience of relevant GI symptoms
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
415 participants (actual)

Study arms

  • Experimental
    Navigated: Screening patient navigation

    Clinic patients who received navigation

    Behavioral: Screening patient navigation

  • Active comparator
    Non-Navigated

    Randomly matched sample of non-navigated clinic patients

    Behavioral: Non-Navigated

Interventions

  • BehavioralScreening patient navigation

    The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.

  • BehavioralNon-Navigated

    Randomly matched sample of non-navigated clinic patients

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What researchers measure

Primary outcomes

  1. Colonoscopy completion

    Time frame: 2 years

07

Study locations

1 site
  • Univeristy of Nevada, Reno
    Reno, Nevada 89557, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03031171
Lead sponsor
University of Nevada, Reno
Collaborators
National Institutes of Health (NIH), University of California, Davis, National Institute of General Medical Sciences (NIGMS)
Responsible party
Sponsor
First posted
Jan 25, 2017
Start date
Apr 2010
Primary completion
Aug 2011
Completion
Sep 2011
Last update
Jan 25, 2017

Study contacts

Paul Devereux, PhD, MPH
principal investigator · University of Nevada, Reno

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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