Patient Navigator Project

Breast Cancer Clinical Trial

Official title:

Patient Navigator Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375024
• Other study ID #: MCC-14718
• Status: Completed
• Phase: N/A
• First received: September 11, 2006
• Last updated: November 2, 2012
• Start date: May 2007
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1267
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer

Intervention

Procedure:
• Patient Navigation
Inclusion of Patient Navigator in treatment plan.
• Clinic Staff
Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire Results Regarding Time to Diagnosis	Time from finding of abnormality to definitive diagnosis	Individual per patient	No
Secondary	Patient Satisfaction Questionaire Results		At end of patient participation	No
Secondary	Questionnaire Results Regarding Patient Navigators	To determine if patient navigators are cost effective	End of study	No

External Links

•   H Lee Moffiitt Cancer Center & Research Institute website