Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375024
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2006-09-11
Brief Title:
Patient Navigator Project
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Patient Navigator Project
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None