A Phase 4 interventional study of Navigation and Standard of Care in Breast Cancer and Colorectal Cancer, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-09.
Sponsored by University of Rochester · Phase 4, Interventional, and Health services research
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 900 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Navigation through the cancer care system is the intervention
Behavioral: Navigation
Cancer patient receives standard of care.
Behavioral: Standard of Care
Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system
Cancer patients receive standard of care for their cancer treatment
To develop, implement, and evaluate a primary care-based, patient navigation program using specially-trained community health workers. We will investigate the effect of this intervention on timing and quality of cancer-related care.
Time frame: 5 years
Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs.
Time frame: 5 years
The record gives a start of Apr 2007, a primary completion of Jun 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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