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Patient Navigator Project

H. Lee Moffitt Cancer Center and Research Institute logo

H. Lee Moffitt Cancer Center and Research Institute

Status

Completed

Conditions

Breast Cancer
Colon Cancer

Treatments

Procedure: Clinic Staff
Procedure: Patient Navigation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00375024
MCC-14718

Details and patient eligibility

About

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

Full 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.

Enrollment

1,267 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,267 participants in 2 patient groups

1: Patient Navigator
Other group
Description:
Patients will meet with a Patient Navigator regarding their treatment and any related concerns.
Treatment:
Procedure: Patient Navigation
2: Without Navigator
Other group
Description:
Patient will work with existing clinic staff, which does not include a Patient Navigator.
Treatment:
Procedure: Clinic Staff

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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