Ohio Patient Navigator Research Program

Breast Cancer Clinical Trial

— OPNRP  

Official title:

Ohio Patient Navigation Research Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569672
• Other study ID #: OPNRP
• Secondary ID: SIRG-05-253-01NC
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 941
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Breast Cancer Screening Tests
• Abnormal Cervical Cancer Screening Tests
• Abnormal Colon Cancer Screening Tests
• Breast Cancer
• Breast Neoplasms
• Cervical Cancer
• Colon Cancer
• Colonic Neoplasms
• Rectal Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment	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	Number of barriers and effect of barriers on receiving needed tests and treatment	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

External Links

•   Jamesline