Ohio Patient Navigator Research Program

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

941 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Ohio State University (OSU) SCREEN Community Program

NCT06666192

Breast Carcinoma Cervical Carcinoma Colorectal Carcinoma

RECRUITING NA

Community Engaged Colon Cancer Screening Patient Navigator Program

NCT03031171

ColoRectal Cancer

COMPLETED NA

CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

NCT01904656

Colon Cancer Rectal Cancer

COMPLETED NA

Comparing Interventions to Increase Colorectal Cancer Screening

NCT03200366

Colorectal Cancer

COMPLETED NA

Rural Interventions for Screening Effectiveness

NCT02795104

Breast, Cervical or Colorectal Cancer Screening Needed

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Cervical Cancer Colon Cancer Rectal Cancer Abnormal Breast Cancer Screening Tests Abnormal Cervical Cancer Screening Tests Abnormal Colon Cancer Screening Tests

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Patient Navigator matched with subject

Intervention Type BEHAVIORAL

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.

Control Clinics

Subjects are mailed informational/educational materials.

Group Type PLACEBO_COMPARATOR

Subjects are mailed informational/educational materials

Intervention Type BEHAVIORAL

Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.