Skip to main content
OpenTrials
Completed

NCT Number: NCT00375024

Patient Navigator Project

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Procedure

Inclusion of Patient Navigator in treatment plan.

Clinic Staff

Procedure

Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.

Primary outcomes

  1. Questionnaire Results Regarding Time to Diagnosis

    Time frame: Individual per patient

    Time from finding of abnormality to definitive diagnosis

Secondary outcomes

  1. Patient Satisfaction Questionaire Results

    Time frame: At end of patient participation

  2. Questionnaire Results Regarding Patient Navigators

    Time frame: End of study

    To determine if patient navigators are cost effective

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2006
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.