Trial of Patient Navigation-Activation

Study Overview
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Brief Summary
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The University of Rochester, Department of Family Medicine, funded by the National Cancer Institute will train community health workers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial. This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and colorectal cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, patient satisfaction with care and quality of life.

Detailed Description
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Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and enablement is referred to as activation. The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. we will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained community health workers (CHWs). We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs. Project findings will inform national policy regarding patient navigation for cancer.

Official Title
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RCT of Primary Care-based Patient Navigation-Activation

Conditions
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Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Behavioral: Navigation
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receive care at a participating practice Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day Have been newly diagnosed with breast or colorectal cancer Have received notification by the provider of an abnormal breast or colorectal screening result Exclusion Criteria: Cognitively impaired Institutionalized (nursing home, incarcerated) Children <18 Actively involved in cancer treatment at time of presentation Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer History of prior invasive cancer, lymphoma, or leukemia except non-melanoma (basal or squamous of the skin) cancer or CIN (Cervical intraepithelial neoplasia). Prior cancer that has been treated-The rationale for excluding patients with any prior cancers that have been treated is that patient familiarity with the treatment process in general would make care easier even without a navigator. Women who are pregnant at time of enrollment.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation<br>Navigation through the cancer care system is the intervention | Behavioral: Navigation<br>* Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system<br>|
| Active Comparator: Standard of Care<br>Cancer patient receives standard of care. | Behavioral: Standard of Care<br>* Cancer patients receive standard of care for their cancer treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop, implement, and evaluate a primary care-based, patient navigation program using specially-trained community health workers. We will investigate the effect of this intervention on timing and quality of cancer-related care. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PNRP, navigation, navigator, activation, disparities, randomized control trial, primary care, racial and ethnic minorities