Patient Navigator Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00375024
First received: September 11, 2006
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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

Condition Intervention
Breast Cancer
Colon Cancer
Procedure: Patient Navigation
Procedure: Clinic Staff

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Navigator Project

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Questionnaire Results Regarding Time to Diagnosis [ Time Frame: Individual per patient ] [ Designated as safety issue: No ]
    Time from finding of abnormality to definitive diagnosis


Secondary Outcome Measures:
  • Patient Satisfaction Questionaire Results [ Time Frame: At end of patient participation ] [ Designated as safety issue: No ]
  • Questionnaire Results Regarding Patient Navigators [ Time Frame: End of study ] [ Designated as safety issue: No ]
    To determine if patient navigators are cost effective


Enrollment: 1267
Study Start Date: May 2007
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Patient Navigator
Patients will meet with a Patient Navigator regarding their treatment and any related concerns.
Procedure: Patient Navigation
Inclusion of Patient Navigator in treatment plan.
2: Without Navigator
Patient will work with existing clinic staff, which does not include a Patient Navigator.
Procedure: Clinic Staff
Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375024

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Richard Roetzheim, MD, MSPH University of South Florida
  More Information

Additional Information:
No publications provided by H. Lee Moffitt Cancer Center and Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00375024     History of Changes
Other Study ID Numbers: MCC-14718
Study First Received: September 11, 2006
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Patient navigation
Breast cancer
Colon cancer
Questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014