Ohio Patient Navigator Research Program (OPNRP)

The Ohio State University

Status: Completed

Conditions: Breast Cancer; Colon Cancer; Abnormal Colon Cancer Screening Tests; Abnormal Breast Cancer Screening Tests; Cervical Cancer; Rectal Cancer; Abnormal Cervical Cancer Screening Tests

Treatments: Behavioral: Patient Navigator matched with subject; Behavioral: Subjects are mailed informational/educational materials

Study type: Interventional

Funder types: Other

Identifiers

NCT01569672

NCI-2012-00205 (Registry Identifier)

SIRG-05-253-01 (Other Grant/Funding Number)

OSU-6100 (Other Identifier)

OPNRP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 941 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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941 participants in 2 patient groups, including a placebo group

Intervention Clinic

Active Comparator group

Description:

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

Treatment:

Behavioral: Patient Navigator matched with subject

Control Clinics

Placebo Comparator group

Description:

Subjects are mailed informational/educational materials.

Treatment:

Behavioral: Subjects are mailed informational/educational materials