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Patient Navigator Project

Patient Navigator Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00375024
Enrollment
1267
Registered
2006-09-12
Start date
2007-05-31
Completion date
2012-11-30
Last updated
2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colon Cancer

Keywords

Patient navigation, Breast cancer, Colon cancer, Questionnaire

Brief summary

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

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.

Interventions

PROCEDUREPatient Navigation

Inclusion of Patient Navigator in treatment plan.

PROCEDUREClinic Staff

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire Results Regarding Time to DiagnosisIndividual per patientTime from finding of abnormality to definitive diagnosis

Secondary

MeasureTime frameDescription
Patient Satisfaction Questionaire ResultsAt end of patient participation
Questionnaire Results Regarding Patient NavigatorsEnd of studyTo determine if patient navigators are cost effective

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026