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Clinical Trials/NCT00375024
NCT00375024
Completed
N/A

Patient Navigator Project

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country1,267 target enrollmentMay 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
1267
Locations
1
Primary Endpoint
Questionnaire Results Regarding Time to Diagnosis
Status
Completed
Last Updated
13 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Questionnaire Results Regarding Time to Diagnosis

Time Frame: Individual per patient

Time from finding of abnormality to definitive diagnosis

Secondary Outcomes

  • Patient Satisfaction Questionaire Results(At end of patient participation)
  • Questionnaire Results Regarding Patient Navigators(End of study)

Study Sites (1)

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