Ohio Patient Navigator Research Program (OPNRP)
|Breast Cancer Cervical Cancer Colon Cancer Rectal Cancer Abnormal Breast Cancer Screening Tests Abnormal Cervical Cancer Screening Tests Abnormal Colon Cancer Screening Tests||Behavioral: Patient Navigator matched with subject Behavioral: Subjects are mailed informational/educational materials||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Ohio Patient Navigation Research Program|
- Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment [ Time Frame: Up to one year ]
- Number of barriers and effect of barriers on receiving needed tests and treatment [ Time Frame: 1 year ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||December 2018|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 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
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.
Placebo Comparator: Control Clinics
Subjects are mailed informational/educational materials.
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569672
|United States, Ohio|
|The Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43201|
|Principal Investigator:||Electra D Paskett, PhD||The Ohio State University Comprehensive Cancer Center|