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
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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).
