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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase IV	Educational/Counseling/Training, Health services research	Active	18 and over	NCI, Other	RO1U01CA116924 NCT00496678

Trial Description

Summary

The University of Rochester, Department of Family Medicine, funded by the National Cancer Institute will train community health workers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial.

This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and colorectal cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, patient satisfaction with care and quality of life.

Further Study Information

Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer.

Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care.

This combination of patient empowerment and enablement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. we will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained community health workers (CHWs). We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs. Project findings will inform national policy regarding patient navigation for cancer.

Eligibility Criteria

Inclusion Criteria:

1. Receive care at a participating practice

2. Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day

3. Have been newly diagnosed with breast or colorectal cancer

4. Have received notification by the provider of an abnormal breast or colorectal screening result

Exclusion Criteria:

1. Cognitively impaired

2. Institutionalized (nursing home, incarcerated)

3. Children <18

4. Actively involved in cancer treatment at time of presentation

5. Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer

6. History of prior invasive cancer, lymphoma, or leukemia except non-melanoma (basal or squamous of the skin) cancer or CIN (Cervical intraepithelial neoplasia).

7. Prior cancer that has been treated—The rationale for excluding patients with any prior cancers that have been treated is that patient familiarity with the treatment process in general would make care easier even without a navigator.

8. Women who are pregnant at time of enrollment.

Trial Contact Information

Trial Lead Organizations/Sponsors

James P. Wilmot Cancer Center at University of Rochester Medical Center

Kevin Fiscella, M.D., MPH

Principal Investigator

Starlene Loader, RN, BSN, BA		Ph: (585) 506-9484 Ext.108
		Email: Starlene_Loader@urmc.rochester.edu

U.S.A.
New York
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Starlene Loader, RN, BSN, BA	Ph: 585-506-9484 Ext.108
			Email: Starlene_Loader@urmc.rochester.edu
		Samantha Hendren, M.D.	Sub-Investigator
		Ronald Epstein, M.D.	Sub-Investigator
		Sharon Humiston, M.D., MPH	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00496678
Information obtained from ClinicalTrials.gov on March 18, 2009