Community Engaged Colon Cancer Screening Patient Navigator Program

NCT ID: NCT03031171

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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ColoRectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Navigated: Screening patient navigation

Clinic patients who received navigation

Group Type EXPERIMENTAL

Screening patient navigation

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Non-Navigated

Intervention Type BEHAVIORAL

Randomly matched sample of non-navigated clinic patients

Interventions

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Screening patient navigation

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

Intervention Type BEHAVIORAL

Non-Navigated

Randomly matched sample of non-navigated clinic patients

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Insurance, no history of colon cancer,

Exclusion Criteria

* No experience of relevant GI symptoms
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Devereux, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Reno

Locations

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Univeristy of Nevada, Reno

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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8P20GM103440-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SB09/10-034

Identifier Type: -

Identifier Source: org_study_id

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