Breast Cancer Clinical Trial
Official title:
Patient Navigator Project
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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