Patient Navigator Project

Study Overview
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Brief Summary
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Patient Navigation is a Supportive Care Intervention that addresses barriers to quality standard care by providing individualized assistance to patients and families. The NCI is conducting several research programs to test the effectiveness of this approach. The expected outcomes of patient navigation through the cancer care system include: Timely, definitive diagnosis following an abnormal test Timely treatment following positive diagnosis Patient satisfaction with the diagnostic and care system experience

Detailed Description
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The goal of our local project is to provide Tampa Bay with a culturally appropriate Patient Navigator Program that will decrease delay in diagnosis and delivery of cancer care in an acceptable and cost-effective manner leading to lower cancer mortality among our underserved populations. We will partner with community health centers in the Tampa Bay area to provide an avenue for patients who have received an abnormal screening for breast and colorectal cancer to easier pilot the course of the healthcare system. The populations served by this program will include African-Americans, Hispanics and rural Whites who are medically underserved due to lack of insurance, documentation issues and a variety of other barriers to health care. The primary outcome to be tested with this program is the time it takes for patients with an abnormality to receive a definitive diagnosis. Secondary outcomes such as patient satisfaction and cost-effectiveness will also be measured. This program occurs in three phases. In Phase I, the aim is to work closely with our key community partners to conduct formative research for the development of an acceptable, appealing, and appropriate Patient Navigator Program. The aim for Phase II is to conduct a group randomized controlled trial by having participating clinics randomly assigned to an intervention or control clinic. The outcomes from this phase in the project will be assessed through chart reviews, patient satisfaction surveys and other survey methods. In Phase III a comprehensive evaluation on the program will be produced and disseminated nationally.

Official Title
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Patient Navigator Project

Conditions
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Breast Cancer, Colon Cancer

Intervention / Treatment
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* Procedure: Patient Navigation
* Procedure: Clinic Staff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receive health care at one of the enrolled clinics Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement). Exclusion Criteria: Persons with previous history of breast or colon cancer will be excluded from the study

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1: Patient Navigator<br>Patients will meet with a Patient Navigator regarding their treatment and any related concerns. | Procedure: Patient Navigation<br>* Inclusion of Patient Navigator in treatment plan.<br>|
| Other: 2: Without Navigator<br>Patient will work with existing clinic staff, which does not include a Patient Navigator. | Procedure: Clinic Staff<br>* Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Results Regarding Time to Diagnosis | Time from finding of abnormality to definitive diagnosis | Individual per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Questionaire Results |  | At end of patient participation | 
| Questionnaire Results Regarding Patient Navigators | To determine if patient navigators are cost effective | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient navigation, Breast cancer, Colon cancer, Questionnaire