Patient Navigator Project
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|ClinicalTrials.gov Identifier: NCT00375024|
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : November 6, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colon Cancer||Procedure: Patient Navigation Procedure: Clinic Staff||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Patient Navigator Project|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2012|
1: Patient Navigator
Patients will meet with a Patient Navigator regarding their treatment and any related concerns.
Procedure: Patient Navigation
Inclusion of Patient Navigator in treatment plan.
2: Without Navigator
Patient will work with existing clinic staff, which does not include a Patient Navigator.
Procedure: Clinic Staff
Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.
- Questionnaire Results Regarding Time to Diagnosis [ Time Frame: Individual per patient ]Time from finding of abnormality to definitive diagnosis
- Patient Satisfaction Questionaire Results [ Time Frame: At end of patient participation ]
- Questionnaire Results Regarding Patient Navigators [ Time Frame: End of study ]To determine if patient navigators are cost effective
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375024
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Richard Roetzheim, MD, MSPH||University of South Florida|