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Ohio Patient Navigation Research Program

Phase 4
18 Years
Open (Enrolling)
Breast Cancer, Cervical Cancer, Colon Cancer, Rectal Cancer, Abnormal Finding in the Breast, Cervix, or Colon and Rectum

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Trial Information

Ohio Patient Navigation Research Program

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:


- 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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Outcome Measure:

Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment

Outcome Time Frame:

Up to one year

Safety Issue:


Principal Investigator

Electra D Paskett, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ohio State University Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Cervical Cancer
  • Colon Cancer
  • Rectal Cancer
  • Abnormal Finding in the Breast, Cervix, or Colon and Rectum
  • Navigator
  • Breast Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Uterine Cervical Neoplasms



The Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210