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Patient Navigator Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375024
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : November 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1267 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Questionnaire Results Regarding Time to Diagnosis [ Time Frame: Individual per patient ]
    Time from finding of abnormality to definitive diagnosis

Secondary Outcome Measures :
  1. Patient Satisfaction Questionaire Results [ Time Frame: At end of patient participation ]
  2. Questionnaire Results Regarding Patient Navigators [ Time Frame: End of study ]
    To determine if patient navigators are cost effective

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00375024

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United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
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Principal Investigator: Richard Roetzheim, MD, MSPH University of South Florida
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT00375024    
Other Study ID Numbers: MCC-14718
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Patient navigation
Breast cancer
Colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms by Site
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases