Patient Navigation was a term first used to describe case management of patients in need of cancer screening or with cancer screening abnormalities.8
This term is now being widely used to describe a broad array of roles and functions, from traditional administrative assistant positions, community outreach workers, social workers, nurses, and patient advocates.9
The diversity of job and role descriptions, coupled with little data on the outcomes of these programs, hampers the incorporation of these roles as part of reimbursed, routine care available to select or all populations. While several state and national bills have already approved funding for patient navigation programs,37–39
incorporation into Medicare or Medicaid services of more widespread patient navigation systems for vulnerable populations requires stronger evidence of its benefits and costs.
The NCI Patient Navigation Research Program is unique in examining the outcomes of care in patient navigation for persons across four different types of cancer, and across multiple diverse clinical care sites and populations. The study will assess the ability of patient navigation to facilitate timely and quality care from the initial cancer screening abnormality through the completion of initial cancer therapy. By developing a core training program, this program will develop curricula we anticipate will be useful for navigator programs throughout the country. By recording and linking patient navigation activities between the navigator and each patient, we will be able to conduct secondary analyses on the effectiveness of navigation as a function of work load, activities of the navigator and provide critical information on the optimal caseload for a navigator.
The PNRP emphasizes the importance of beginning measurement of time in care at the point of abnormal screening. To encompass all potential delays in care, we have defined our endpoints as time until definitive diagnosis and time to initiation and completion of initial therapies. Our study will not have power to assess changes in stage of diagnosis or survival benefits of navigation. Benefits of navigation will be inferred from improvements in timeliness of care, and completeness of treatment. Other studies have documented that timeliness and completion of recommended therapy are associated with improvements in survival, especially in the elderly.29, 30, 40
Our research study does not address the issues of screening, nor of survivorship following treatment.
The limitations of our methodology reflect the limitations inherent in research addressing dissemination of programs within community settings. The cooperative group includes both randomized clinical trials, which assign subjects to the intervention and control groups, and quasi-experimental designs, with assignment based upon site of care. These differences reflect community and local needs when conducting community-based participatory research. Each methodology has its strengths and weaknesses in addressing the questions of interest in the research project. The randomized trial methodologies benefit from balance of known and unknown confounders between the two groups studied, but is limited in the generalizability to those subjects able to be reached and willing to be randomized. Those sites that include all subjects based upon site of care risk confounding by site of care; however, by designing the intervention as a new standard of care that allows collection of data on all eligible subjects, they benefit in generalizability by the inclusion of those very subjects most difficult to reach and for whom the navigation intervention is designed to provide support. A second major limitation is the lack of power to address stage at diagnosis and survival outcomes and the need to utilize intermediate outcomes of timeliness of completion of care and patient satisfaction.
The multidisciplinary approach to cancer care has resulted in significant survival gains, but at the cost of increased complexity within the health care system. The persistent gap in translating these improvements in cancer care to vulnerable populations will result in persistent and even widening racial disparities in cancer outcomes, unless we develop and disseminate specific interventions to facilitate the process of care. Patient navigation represents a novel approach to addressing the barriers to completion of cancer care, in groups of patients vulnerable to inadequate care by virtue of their economic, cultural, educational, racial and/or ethnic status.