Peter C. Raich

Patient navigation: State of the art or is it science?†

First implemented in 1990, patient navigation interventions are emerging today as an approach to reduce cancer disparities. However, there is lack of consensus about how patient navigation is defined, what patient navigators do, and what their qualifications should be. Little is known about the efficacy and cost‐effectiveness of patient navigation. For this review, the authors conducted a qualitative synthesis of published literature on cancer patient navigation. By using the keywords ‘navigator’ or ‘navigation’ and ‘cancer,’ 45 articles were identified in the PubMed database and from reference searches that were published or in press through October 2007. Sixteen studies provided data on the efficacy of navigation in improving timeliness and receipt of cancer screening, diagnostic follow‐up care, and treatment. Patient navigation services were defined and differentiated from other outreach services. Overall, there was evidence of some degree of efficacy for patient navigation in increasing participation in cancer screening and adherence to diagnostic follow‐up care after the detection of an abnormality. The reported increases in screening ranged from 10.8% to 17.1%, and increases in adherence to diagnostic follow‐up care ranged from 21% to 29.2% compared with control patients. There was less evidence regarding the efficacy of patient navigation in reducing either late‐stage cancer diagnosis or delays in the initiation of cancer treatment or improving outcomes during cancer survivorship. There were methodological limitations in most studies, such as a lack of control groups, small sample sizes, and contamination with other interventions. Although cancer‐related patient navigation interventions are being adopted increasingly across the United States and Canada, further research will be necessary to evaluate their efficacy and cost‐effectiveness in improving cancer care. Cancer 2008.

National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures.

Patient, provider, and systems barriers contribute to delays in cancer care, a lower quality of care, and poorer outcomes in vulnerable populations, including low‐income, underinsured, and racial/ethnic minority populations. Patient navigation is emerging as an intervention to address this problem, but navigation requires a clear definition and a rigorous testing of its effectiveness. Pilot programs have provided some evidence of benefit, but have been limited by evaluation of single‐site interventions and varying definitions of navigation. To overcome these limitations, a 9‐site National Cancer Institute Patient Navigation Research Program (PNRP) was initiated.

Impact of Patient Navigation on Timely Cancer Care: The Patient Navigation Research Program

BACKGROUND Patient navigation is a promising intervention to address cancer disparities but requires a multisite controlled trial to assess its effectiveness. METHODS The Patient Navigation Research Program compared patient navigation with usual care on time to diagnosis or treatment for participants with breast, cervical, colorectal, or prostate screening abnormalities and/or cancers between 2007 and 2010. Patient navigators developed individualized strategies to address barriers to care, with the focus on preventing delays in care. To assess timeliness of diagnostic resolution, we conducted a meta-analysis of center- and cancer-specific adjusted hazard ratios (aHRs) comparing patient navigation vs usual care. To assess initiation of cancer therapy, we calculated a single aHR, pooling data across all centers and cancer types. We conducted a metaregression to evaluate variability across centers. All statistical tests were two-sided. RESULTS The 10521 participants with abnormal screening tests and 2105 with a cancer or precancer diagnosis were predominantly from racial/ethnic minority groups (73%) and publically insured (40%) or uninsured (31%). There was no benefit during the first 90 days of care, but a benefit of navigation was seen from 91 to 365 days for both diagnostic resolution (aHR = 1.51; 95% confidence interval [CI] = 1.23 to 1.84; P < .001)) and treatment initiation (aHR = 1.43; 95% CI = 1.10 to 1.86; P < .007). Metaregression revealed that navigation had its greatest benefits within centers with the greatest delays in follow-up under usual care. CONCLUSIONS Patient navigation demonstrated a moderate benefit in improving timely cancer care. These results support adoption of patient navigation in settings that serve populations at risk of being lost to follow-up.

Patient Navigation Improves Cancer Diagnostic Resolution: An Individually Randomized Clinical Trial in an Underserved Population

Background: Barriers to timely resolution of abnormal cancer screening tests add to cancer health disparities among low-income, uninsured, and minority populations. We conducted a randomized trial to evaluate the impact of lay patient navigators on time to resolution and completion of follow-up testing among patients with abnormal screening tests in a medically underserved patient population. Methods: Denver Health, the safety-net health care system serving Denver, is one of 10 performance sites participating in the Patient Navigation Research Program. Of 993 eligible subjects with abnormal screening tests randomized to navigation and no-navigation (control) arms and analyzed, 628 had abnormal breast screens (66 abnormal clinical breast examinations, 304 BIRADS 0, 200 BIRADS 3, 58 BIRADS 4 or 5) whereas 235 had abnormal colorectal and 130 had abnormal prostate screens. Results: Time to resolution was significantly shorter in the navigated group (stratified log rank test, P < 0.001). Patient navigation improved diagnostic resolution for patients presenting with mammographic BIRADS 3 (P = 0.0003) and BIRADS 0 (P = 0.09), but not BIRADS 4/5 or abnormal breast examinations. Navigation shortened the time for both colorectal (P = 0.0017) and prostate screening resolution (P = 0.06). Participant demographics included 72% minority, 49% with annual household income less than

Effects of obesity and race on prognosis in lymph node-negative, estrogen receptor-negative breast cancer

10,000, and 36% uninsured. Conclusions: Patient navigation positively impacts time to resolution of abnormal screening tests for breast, colorectal, and prostate cancers in a medically underserved population. Impact: By shortening the time to and increasing the proportion of patients with diagnostic resolution patient navigation could reduce disparities in stage at diagnosis and improve cancer outcomes. Cancer Epidemiol Biomarkers Prev; 21(10); 1629–38. ©2012 AACR.

Patient Navigation for Breast and Colorectal Cancer Treatment: A Randomized Trial

SummaryBackgroundSeveral factors may contribute to poorer prognosis for obese breast cancer patients, including unfavorable disease features, the influence of fat on estrogen availability, co-morbidity, and socio-demographic factors. Both obesity and estrogen receptor negative (ER-) tumors are more prevalent in black women than in whites in North America. We evaluated obesity and race in relation to outcomes in women with ER-breast cancer.MethodsAmong 4077 women from National Surgical Adjuvant Breast and Bowel Project clinical trials for node-negative, ER-breast cancer, we evaluated disease-free survival (DFS) and its constituents (tumor recurrence, contralateral breast cancer (CBC), second primary cancers, deaths prior to these events) and mortality in relation to body mass index (BMI) and race, using statistical modeling to account for other prognostic factors.ResultsCompared to those of normal weight (BMI≤24.9), DFS hazard was greater for obese (BMI ≥ 30) women [hazard ratio (HR)=1.16, 95% confidence interval (CI)=1.01–1.33]. Obesity did not increase recurrence hazard, but did influence CBC (HR=2.08, 95% CI=1.22–3.55 in postmenopausal women) and second cancers (HR=1.49, 95% CI=1.06–2.10). Mortality increased with obesity; when partitioned by likely cause, those with BMI ≥ 35.0 had greater risk of non-breast cancer mortality (HR=1.86, 95% CI=1.21–2.84). Relative to whites and adjusted for BMI, black women had greater hazard for DFS (HR=1.17, 95% CI=1.00–1.38), CBC (HR=1.37, 95% CI=0.94–1.99), and non-breast cancer deaths (HR=2.10, 95% CI=1.45–3.03); risk for deaths likely due to breast cancer was closer to that in whites (HR=1.18; 95% CI=0.93–1.50).ConclusionsFor women with node-negative, ER-breast cancer from clinical trials, obesity did not increase recurrence risk, but was associated with greater risk for second cancers, CBC, and mortality, particularly non-breast cancer deaths. Less favorable prognosis for black women persists in clinical trials, and is in part attributable to non-breast cancer outcomes.

Lymphomatoid granulomatosis and Epstein-Barr virus

Background: There is limited high-quality evidence about the impact of patient navigation (PN) on outcomes for patients with diagnosed cancer. Methods: We pooled data from two sites from the national Patient Navigation Research Program. Patients (n = 438) with newly diagnosed breast (n = 353) or colorectal cancer (n = 85) were randomized to PN or usual care. Trained lay navigators met with patients randomized to PN to help them assess treatment barriers and identify resources to overcome barriers. We used intent-to-treat analysis to assess time to completion of primary treatment, psychologic distress (impact of events scale), and satisfaction (patient satisfaction with cancer-related care) within 3 months after initiation of cancer treatment. Results: The sample was predominantly middle-aged (mean age = 57) and female (90%); 44% were race-ethnic minorities (44%), 46% reported lower education levels, 18% were uninsured, and 9% reported a non-English primary language. The randomized groups were comparable in baseline characteristics. Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment, satisfaction with cancer-related care, or psychologic distress. Subgroup analysis showed that socially disadvantaged patients (i.e., uninsured, low English proficiency, and non-English primary language) who received PN reported higher satisfaction than those receiving usual care (all P < 0.05). Navigated patients living alone reported greater distress than those receiving usual care. Conclusions: Although the primary analysis showed no overall benefit, the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals. Impact: PN for cancer patients may not necessarily reduce treatment time nor distress. Cancer Epidemiol Biomarkers Prev; 21(10); 1673–81. ©2012 AACR.

Conditional Survival and the Choice of Conditioning Set for Patients With Colon Cancer: An Analysis of NSABP Trials C-03 Through C-07

A case report of a patient with lymphomatoid granulomatosis presenting initially as a reactivated Epstein‐Barr virus infection is presented. Epstein‐Barr virus is proposed in the possible role of establishing of an immunologically compromised state that may have set the stage for dissemination of this disease process. Of interest is the fact that successful chemotherapeutic management of the disease was accomplished using prednisone and cyclophosphamide. Furthermore, this clinical success was reflected in a decreasing Epstein‐Barr virus early antigen‐antibody titers accompanied by increasing antivirus capsid antigen titers; hence, it appears that laboratory markers of the response of lymphomatoid granulomatosis to treatment are available in the form of soluble immune complexes, antibodies to Epstein‐Barr virus‐coded antigens early antigens, Epstein‐Barr nuclear antigens and/or virus capsid antigens as well as the active E rosette assay for T‐cells. Finally, these data, although supporting the role of Epstein‐Barr virus in the pathogenesis of lymphomatoid granulomatosis, suggest the need for further study in additional patients to verify the results.

Can Patient Navigation Improve Receipt of Recommended Breast Cancer Care? Evidence From the National Patient Navigation Research Program

PURPOSE Colon cancer overall survival (OS) is usually computed from the time of diagnosis. Survival gives the initial prognosis but does not reflect how prognosis changes with changing hazard rates over time. Conditional survival (probability of surviving y additional years given they have survived x years [CS or OS|OS]) is an alternative measure that accounts for elapsed time since diagnosis, providing more relevant prognostic information. We extend the concept of CS to condition on the set of patients alive, recurrence-free, and second primary cancer-free (disease-free survival [OS|DFS]). PATIENTS AND METHODS Using data from National Surgical Adjuvant Breast and Bowel Project trials C-03 through C-07, 5-year OS|DFS was calculated on patients who were disease free up to 5 years after diagnosis, stratified by age, stage, nodal status, and performance status (PS). RESULTS For stage II, OS|DFS improved from 87% to 92% at 5 years. For stage III, OS|DFS improved from 69% to 88%. Patients younger than 50 years showed OS|DFS improvement from 79% to 95%; those older than 70 years showed no sustained increase in OS|DFS. Node-negative patients with > or = 12 nodes resected showed little change (89% to 94%); those with more than four positive nodes showed an improvement (57% to 86%). Patients with a PS of 0 or 1 demonstrated a small improvement; those with a PS of 2 did not (64% to 58%). CONCLUSION Prognosis improves over time for almost all groups of patients with colon cancer, especially those with positive nodes. OS|DFS is a more relevant measure of prognosis for those who have already survived disease free a period of time after diagnosis.

National Cancer Institute Patient Navigation Research Program

PURPOSE Poor and underserved women face barriers in receiving timely and appropriate breast cancer care. Patient navigators help individuals overcome these barriers, but little is known about whether patient navigation improves quality of care. The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care. PATIENTS AND METHODS Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following: initiation of antiestrogen therapy in patients with hormone receptor-positive breast cancer; initiation of postlumpectomy radiation therapy; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm. This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants. RESULTS Among participants eligible for antiestrogen therapy, navigated participants (n = 380) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls (n = 381; odds ratio [OR], 1.73; P = .004) in a multivariable analysis. Among the participants eligible for radiation therapy after lumpectomy, navigated participants (n = 255) were no more likely to receive radiation (OR, 1.42; P = .22) than control participants (n = 297). CONCLUSION We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy. Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care.