Patient Navigator Project
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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 |
- Questionnaire Results Regarding Time to Diagnosis [ Time Frame: Individual per patient ] [ Designated as safety issue: No ]Time from finding of abnormality to definitive diagnosis
- 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 |
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| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | Richard Roetzheim, MD, MSPH | University of South Florida |
More Information
Additional Information:
No publications provided
| 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 Colonic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013