Ohio Patient Navigator Research Program (OPNRP)

February 22, 2021 updated by: Electra Paskett, Ohio State University Comprehensive Cancer Center

Ohio Patient Navigation Research Program

The Ohio Patient Navigator Research Program (OPNRP) proposes to alleviate disparities in relation to the timely diagnosis and treatment of breast, cervical and colorectal cancer in Columbus, OH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of the Ohio Patient Navigator Research Program (OPNRP) is to facilitate timely access to quality, standard cancer care for persons diagnosed with breast, cervical, and colorectal cancer in a culturally sensitive manner. This program will be carried out within clinics of The Ohio State University Primary Care Network (OSU PCN) and the Columbus Neighborhood Health Centers (CNHC) in Columbus, Ohio with a preponderance of patients from underserved (i.e., racial/ethnic minorities, people of lower socioeconomic status, and the elderly) populations. This goal will be accomplished by completing the following objectives:

Objectives

  • Develop the OPNRP through the work of a consortium of institutions including The Ohio State University Comprehensive Cancer Center (OSUCCC) and James Cancer Hospital (JCH), the Ohio Division of the American Cancer Society (ACS), and the Ohio Commission on Minority Health (OCMH);
  • Conduct a formative research phase to assess referral patterns and barriers to prompt diagnosis and treatment services, as well as strategies to overcome barriers among patients of these clinic networks;
  • Implement and evaluate the patient navigator program in 12 primary care clinics using a group randomized, controlled design to assess the efficacy of the intervention to reduce the time to delivery of standard cancer diagnosis and services and non-cancer resolution or cancer diagnosis and treatment after the diagnosis of an abnormal finding from a cancer detection procedure for breast, cervical or colorectal cancer, as well as improve patient satisfaction with care and quality of life;
  • Conduct a process evaluation to assess the barriers to implementation of the intervention program, the features of the intervention (e.g., appointments kept/missed, materials provided to patients, etc.), patient satisfaction with the navigator, and clinic perceptions of the navigator program; and
  • Conduct a cost-effectiveness evaluation of the navigator program. Results from this study will be disseminated throughout Ohio by community partners and used to provide information on concrete ways to utilize patient navigators to reduce the burden of cancer in underserved populations, a goal of the National Cancer Institute (NCI) and Department of Health and Human Services (DHS) Healthy People 2010. The OPNRP is one of nine grantees in NCI/ACS's Patient Navigator Research Program (PNRP).

Study Type

Interventional

Enrollment (Actual)

941

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43201
        • The Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over age 18 years
  • Be a regular patient of the primary care practice
  • Be able to give informed consent
  • Have had either an abnormal screening test, an abnormal diagnostic test, or an abnormal clinical finding leading to diagnostic testing for cervical, breast, or colorectal cancer, or a diagnosis of cervical, breast, or colorectal cancer
  • Speak and understand English, or Spanish. For those participants who do not speak and understand English they will only be enrolled/consented into the program if translation services are available.

Exclusion Criteria:

  • Cognitively impaired
  • Prior history of cancer (except for nonmelanoma of the skin)
  • Living in a nursing home
  • Prior navigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Clinic
Patient Navigator matched with subjects. Patient Navigators will be matched with subjects at the intervention clinics and will assist patients with questions, issues or concerns with their cancer treatment/diagnosis or abnormal test results and followup test or treatments
Behavioral: Patient Navigator matched with subject
Subject is matched with a patient navigator. The patient navigator calls the patient. The amount of time between the abnormal test and treatment will be measured.
Placebo Comparator: Control Clinics
Subjects are mailed informational/educational materials.
Behavioral: Subjects are mailed informational/educational materials
Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment
Time Frame: Up to one year
How much time exist between an abnormal test diagnosis for breast, cervical or colon or rectum cancer to when the needed follow up tests or treatment is done.
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of barriers and effect of barriers on receiving needed tests and treatment
Time Frame: 1 year
List of and number of barriers and qualitatively how they influence a person's reasons for not getting a needed screening test or treatment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Electra D Paskett, PhD, The Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 31, 2010

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPNRP
  • SIRG-05-253-01 (Other Grant/Funding Number: American Cancer Society)
  • NCI-2012-00205 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
  • OSU-6100 (Other Identifier: OSU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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