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Patient Navigator Project

18 Years
Not Enrolling
Breast Cancer, Colon Cancer

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Trial Information

Patient Navigator Project

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Questionnaire Results Regarding Time to Diagnosis

Outcome Description:

Time from finding of abnormality to definitive diagnosis

Outcome Time Frame:

Individual per patient

Safety Issue:


Principal Investigator

Richard Roetzheim, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • Patient navigation
  • Breast cancer
  • Colon cancer
  • Questionnaire
  • Breast Neoplasms
  • Colonic Neoplasms



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612