NCT03031171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

January 21, 2017

Last Update Submit

January 21, 2017

Conditions

ColoRectal Cancer

Keywords

community engagement, navigation, cancer screening

Outcome Measures

Primary Outcomes (1)

  • Colonoscopy completion

    2 years

Study Arms (2)

Navigated: Screening patient navigation

EXPERIMENTAL

Clinic patients who received navigation

Behavioral: Screening patient navigation

Non-Navigated

ACTIVE COMPARATOR

Randomly matched sample of non-navigated clinic patients

Behavioral: Non-Navigated

Interventions

Screening patient navigationBEHAVIORAL

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

Navigated: Screening patient navigation
Non-NavigatedBEHAVIORAL

Randomly matched sample of non-navigated clinic patients

Non-Navigated

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insurance, no history of colon cancer,

You may not qualify if:

  • No experience of relevant GI symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Nevada, Reno

Reno, Nevada, 89557, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Paul Devereux, PhD, MPH

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2017

First Posted

January 25, 2017

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

January 25, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)