Ohio Patient Navigator Research Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Ohio Patient Navigation Research Program

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

Intervention / Treatment
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* Behavioral: Patient Navigator matched with subject
* Behavioral: Subjects are mailed informational/educational materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Clinic<br>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<br>* 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.<br>|
| Placebo Comparator: Control Clinics<br>Subjects are mailed informational/educational materials. | Behavioral: Subjects are mailed informational/educational materials<br>* Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Navigator