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Patient Navigation in the Safety Net:CONNECTeDD

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 Health services research Active 18 and over Other U01-CA-116892-03
U01-CA-116892-03, NCT00613275

Trial Description

Summary

The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers 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 Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's 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 engagement 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 patient Navigators who work within one of the six affiliated Community Health Centers. 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:

Receive care at one of the 6 participating community Health centers

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

Have been newly diagnosed with breast or colorectal cancer

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

Exclusion Criteria:

Cognitively impaired

Institutionalized (nursing home, incarcerated)

Children <18

Actively involved in cancer treatment at time of presentation

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Boston University Cancer Research Center

Karen M Freund, MD, MPH

Principal Investigator

Tracy Battaglia, MD, MPH

Principal Investigator

Christina Santana, MPH		Ph: 617-638-8036
		Email: christina.santana@bmc.org

Trial Sites

U.S.A.

Massachusetts

Boston

Boston University Cancer Research Center

Karen M Freund, MD, MPH Ph: 617-638-8036

Email: karen.freund@bmc.org

Bonnie J Sherman, Ph.D. Ph: 617-638-8033

Email: bsherman@bu.edu

Karen M Freund, MD, MPH Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00613275
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.