Patient Navigation in Breast Cancer: A Systematic Review
Robinson-White, Stephanie MD; Conroy, Brenna BS; Slavish, Kathleen H. BA; Rosenzweig, Margaret PhD, APN-BC, AOCNP
Authors' Affiliations: University of Pittsburgh School of Medicine (Dr Robinson-White) and University of Pittsburgh School of Nursing (Dr Rosenzweig, Mss Slavish and Conroy).
Corresponding author: Margaret Rosenzweig, PhD, APN-BC, AOCNP, 3500 Victoria St, Pittsburgh, PA 15261 (email@example.com).
Accepted for publication September 30, 2009.
Background: The role of the patient navigator in cancer care and specifically in breast cancer care has grown to incorporate many titles and functions.
Objective: To better evaluate the outcomes of patient navigation in breast cancer care, a comprehensive review of empiric literature detailing the efficacy of breast cancer navigation on breast cancer outcomes (screening, diagnosis, treatment, and participation in clinical research) was performed.
Methods: Published articles were reviewed if published in the scientific literature between January 1990 and April 2009. Searches were conducted using PubMed and Ovid databases. Search terms included MeSH (Medical Subject Headings) terms, "patient navigator," "navigation," "breast cancer," and "adherence."
Results: Data-based literature indicates that the role of patient navigation is diverse with multiple roles and targeted populations. Navigation across many aspects of the breast cancer disease trajectory improves adherence to breast cancer care. The empiric review found that navigation interventions have been more commonly applied in breast cancer screening and early diagnosis than for adherence to treatment.
Conclusion: There is evidence supporting the role of patient navigation in breast cancer to improve many aspects of breast cancer care.
Implications for Practice: Data describing the role of patient navigation in breast cancer will assist in better defining future direction for the breast navigation role. Ongoing research will better inform issues related to role definition, integration into clinical breast cancer care, impact on quality of life, cost-effectiveness, and sustainability.
Patient navigators have become highly prevalent within cancer care. Cancer care navigation was originally conceived by Harold P. Freeman, MD, in response to disproportionate late-stage cancer presentation among African Americans attributed, in part, to an inability to access complex and often confusing existing cancer care services. In an effort to address those disparities and improve cancer care access, Freeman1 started the first patient navigator program in 1990 at Harlem Hospital and later expanded to the Breast Examination Center of Harlem and the Ralph Lauren Center for Cancer Care and Prevention. The goal of the navigation intervention was to "assist patients with abnormal findings or cancer in navigating and, at times, circumnavigating to the hospital and human services bureaucracies to accomplish the follow-up and diagnosis of an abnormal finding on cancer screening tests and the treatment of cancer."1 Freeman et al2,3 differentiated patient navigator programs from other services designed to reduce healthcare disparities by emphasizing the need for navigators to be members of the community they intend to serve and that they be familiar with healthcare to allow navigators to personally relate to their patient.
Since 1990, the role of the patient navigator in healthcare and specifically in cancer care has grown to incorporate many titles and functions.4,5 Initially, patient navigation was not meant to address psychological, social, and physical support systems that are mainly directed at improving the quality of life of patients with cancer. However, with the recognition of the interconnection of psychosocial issues with adherence to screening and cancer treatment,6-13 cancer care navigation has evolved to include outcomes encompassing not only screening and diagnostic and treatment adherence but quality-of-life outcomes as well.
Growth of Navigation Role
The promising results of Freeman's1,2 initial navigation program initiated the development of additional patient navigator programs nationally. Many of these programs, although somewhat heterogeneous in their design and implementation, reported success assisting patients through a complex cancer care system.14-19 Program outcomes of navigation in cancer care needed to be defined and rigorously tested.20 Increased interest and requests for financial support of navigation programs created the need for a comprehensive and more rigorous review of navigation methods and outcomes.
In 2002, the National Cancer Institute established funding for the implementation and evaluation of patient navigator programs in cancer care. The primary project is the Patient Navigator Research Program: Eliminating Barriers to Timely Delivery of Cancer Diagnosis and Treatment Services. This program provided funding to 8 institutions nationwide for 5 years "to develop and assess the efficacy and cost-effectiveness of various innovative navigator interventions in communities experiencing cancer health disparities."21Table 1 outlines the location, patient population, navigator characteristics, and specific aims of the National Cancer Institute grantees.
Navigation in Breast Cancer
Cancer navigators are evolving as the cancer care navigation role becomes more defined and delineated in cancer care. Breast cancer is an optimal arena for patient navigation because of known survival benefit of early detection through clinical breast examination, mammography, and early intervention. Navigation is particularly important in breast cancer care because of the documented racial disparity in breast cancer care across the disease trajectory. The 5-year mortality rate after a first diagnosis of breast cancer is 90% for white women, but only 77% for black women.22
The historic explanation for the survival disparity among African American women is late-stage presentation of breast cancer23,24 due to poor adherence to recommended screening tests or nonreporting of clinical symptoms. However, reviews of US cancer studies have also found strong evidence that white patients receive more aggressive initial treatment for breast cancers than do black patients, resulting in higher mortality among the nonwhite populations.25-27 In addition, in the only identified analysis of specifically appointment adherence during systemic breast-cancer therapy, black women were overly represented among women who missed appointments,28 and a greater number of missed appointments correlated with shorter survival.28 Consequently, despite other potential etiologies, there is an increasing need to consider navigation, not only in early detection, but also throughout the breast cancer treatment trajectory.
Navigation is also necessary in breast cancer care to coordinate the multidisciplinary providers and complexity of care across the disease trajectory inherent in breast cancer treatment, including advanced breast cancer.29 Bickell and Young30 described 67 interviews of care providers for early-stage breast cancer patients who described many efforts toward coordination of care for women with early-stage breast cancer, but no consistent methods to track care, receipt of care, or missed appointments. Ongoing research will better inform issues related to role definition, integration into clinical breast cancer care, impact on quality of life, cost-effectiveness, and navigation sustainability.
To evaluate the outcomes of patient navigation in breast cancer care, a comprehensive review of empiric literature detailing the efficacy of breast cancer navigation on outcomes related specifically to breast cancer care (screening, diagnosis, treatment, quality-of-life survivorship, and participation in clinical research) was performed.
Design and Methods
This is a descriptive study of published research evaluating the efficacy of breast cancer navigators and navigation in breast cancer across all aspects of the disease trajectory. Published articles were reviewed if included in the scientific literature between January 1990 and April 2009. Literature search was conducted using PubMed and Ovid databases. Search terms, individually and in combination included MeSH (Medical Subject Headings) terms, "patient navigator," "breast cancer," "medically underserved," and "adherence." The literature search was conducted independently by 2 authors for results verification. When reviewing each navigational intervention study, Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed to ensure an accurate and critical appraisal of the design, conduct, and analysis of each research study. The CONSORT encompasses various initiatives developed by the Consort Group to alleviate the problems of reporting of randomized controlled trials.31 The CONSORT checklist items focus on reporting how the trial was designed, analyzed, and interpreted.31Table 2 was created following CONSORT guidelines and describes the setting, intervention characteristics, study design, sample, goal, results, conclusions, and limitations (Table 2).32-43
If a published article was identified under the approved headings, a determination of the content of the article was made through a review of the published abstract. For an article to meet inclusion criteria, the article had to (1) be data based and (2) include measured efficacy of navigation for women with breast cancer at any stage of the disease continuum. Community education efforts were not included.
PubMed and Ovid Internet search engines resulted in 31 articles meeting the search criteria for patient navigator; 7 for patient navigation and breast cancer; 51,255 for adherence; and 838 journal articles for adherence and breast cancer, by MeSH term match. After applying the inclusion criteria, there were 12 data-based articles evaluating patient navigator efficacy in breast cancer. Articles were analyzed according to specific categories including title, author/year, setting, intervention, design, goal, sample size and racial characteristics of sample, results, conclusions, and limitations (Table 2).
Research studies were conducted during the period from 1999 through April 2009. Nine of 12 interventions (75%) were primarily focused on early-stage intervention, with no navigated role extending into metastatic breast cancer treatment. Most studies (8/12 or 66%) included predominantly or large samples of nonwhite women.
The collection of articles reviewed, although heterogeneous in setting, design, and method, yielded similar outcomes with respect to positive adherence to breast screening and diagnostic follow-up. Goals of navigation interventions were follow-up to screening or clinical breast abnormalities.32-35,38-40,42,43 Some interventions successfully incorporated quality-of-life components into the navigated intervention.37,42 The navigation role, whether tested through randomized controlled trial40-42 or through comparison to historic control,32,34,35,38,39 was effective for moving women to desired outcome in the breast cancer treatment trajectory. Two of the navigation interventions (16%) were nontraditional. One intervention assisted women with only the emotional aspects of a breast cancer diagnosis,37 and another used the navigation role to encourage women to follow through with genetic assessment, rather than tumor evaluation or treatment.41
Clearly, the review of navigation efficacy indicates a positive trend toward adherence to breast cancer screening, follow-up of diagnostic abnormalities, initiation of breast cancer treatment, and stability or improvement in quality of life with patient navigation in breast cancer. These results are encouraging, yet there is still a great deal to pursue in the research agenda. Research design overall is still not appropriately rigorous. Only 3 of the 12 studies were a randomized, controlled design.40-42 Regardless of design, power analysis was not included in any reporting.
Navigation influence can be heavily personally influenced through the strength of an engaging personality. All of the interventions required individuals to deliver the intervention. The interpersonal or "indirect" effect on the interpersonal relationship needs to be separated from the navigation intervention to understand the effects of the individual components of the navigation intervention. The individual navigator's personality and warmth may be an important, integral component of the navigation's success, but it is important to discern if the relationship between the navigator and patient is a direct, quantifiable effect (and measurement tools used to quantify) or an indirect effect of the intervention. These delineations are important for analysis and for dissemination into routine clinical practice.
In addition, few reviews detailed or evaluated the role of navigation through breast cancer treatment, including surgery, chemotherapy, and radiation therapy, and/or long-term hormonal therapy. In addition, all studies concentrated on nonmetastatic breast cancer. Concentrating all navigation research in early-stage, predominantly diagnostic settings does not address the potential navigation needs of women with more advanced-stage illness, women receiving chronic breast-cancer therapy, or women reluctant to finish initial treatment.
Although heterogeneous in location, each of the studies had settings that provided accessible and affordable breast cancer screening and follow-up support to women in predominantly minority, urban, and socioeconomically disadvantaged areas. Each particular study and setting had a unique goal with respect to navigational intervention for women undergoing breast cancer screening. Despite different goals and settings, independent results of each study illustrate similar outcomes. The most compelling is the documented or potential value of accessible, affordable, and supportive breast navigation services across breast cancer settings. These studies were conducted in predominantly minority and economically underserved areas, many in urban cancer centers (10/12 studies), and may be an important intervention toward reducing breast cancer outcome disparity for underserved populations. Interventions using navigation for optimal breast cancer outcomes should be extended to rural settings.
The role of the patient navigator in these studies (Table 2), although heterogeneous, always involved coordination or encouragement toward further care. The roles varied in the scope and the attention toward an emotional or quality-of-life component. More information is desired. The extent of the protocol of the navigator role was not well described in any study. For example, we do not know of a script or an algorithm of response in the encouragement components of the interventions. These data could be helpful for further analysis or replication of the navigator role. The navigator characteristics were not always addressed.32,34,36,38 Despite literature supporting the importance of survivors and race-matched interventionists,2-4 navigators seemed to be effective without meeting all traditional criteria (member of the community they intend to serve and cancer survivor).2 None of the studies specifically identified the navigators as being race matched. Two studies35,37 used breast cancer survivors in a navigator role. When described, most navigation roles were nonhealthcare professionals educated for a primarily supportive, co-coordinating role.39-41 Importantly, the cost of the navigation role/patient benefit was not discussed. The lack of attention to the cost of navigation will limit its clinical usefulness.
There are several limitations to this review of navigational research. First, concentrating all navigational research in early-stage breast cancer does not address the potential navigational needs of women with more advanced breast cancer. Further research directed at examining navigational interventions for women with advanced breast cancer status is necessary.
The extent of the navigation protocol was not well described in any study. It would be beneficial to review summarized navigation scripts and protocols to analyze the institutional resources and personnel expertise needed to replicate successful navigational interventions.
Implications for Nursing
Disparities in healthcare access extend beyond race/ethnicity and sex and include age, socioeconomic status, disability, geographic location, and sexual orientation. One important consideration for nursing is the coordination of navigation services with ongoing care. A lay community member involved in counseling and coordination of services may add complexity to an already complex breast caner care plan. Nursing needs input into navigation training, evaluation, and development of care protocols to ensure that patients are provided accurate, streamlined, evidence-based care.
There are important considerations in the evaluation of patient navigation in breast cancer care. First, it appears that navigation is an effective encouragement for women to advance through breast cancer screening into further diagnostic evaluation and even into breast cancer treatment. More scientific rigor in navigation evaluation is necessary. Additional retrospective research quantifying the risk of diagnostic and treatment delay to specific breast cancer outcomes including survival is needed across the breast cancer treatment trajectory. These findings will likely validate the justification for the navigation role. The important question of breast cancer navigation efficacy in encouraging adherence to breast cancer treatment is unanswered.
In addition, although the results of patient navigation in cancer care are generally positive, the results need to be demarcated according to race, income, disease stage, and other important demographic characteristics so that the efficacy of patient navigation in breast cancer can be delineated according to specific population groups. Ongoing and future research will detail the roles of navigation throughout the breast cancer continuum and continue to strengthen research design for optimal evaluation and utilization of patient navigation programs.
Lastly, it is very important to note that the addition of the role of patient navigation in breast cancer does not adequately address the larger issues of cancer care disparity, complexity, and fragmentation of cancer care. Navigation is a "Band-Aid" rather than a solution to the larger healthcare issues, particularly lack of equal access in cancer care. In a 2001 report to the president, "Voices of a Broken System: Real People, Real Problems," Freeman and Reuben44 acknowledged the value of the navigator role in cancer care by advocating for community-based programs, including patient navigator programs, that help people obtain cancer information, screening, treatment, and supportive services.42 It appears that navigation is effective in encouraging appropriate breast cancer care in many diverse settings and for many populations. Further research should be encouraged.
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