Geographic proximity and racial disparities in cancer clinical trial participation.

This study assessed the effects of race and place of residence on clinical trial participation by patients seen at a designated NCI comprehensive cancer center. Clinical trial accrual to cancer case ratios were evaluated using a database of residents at the continental United States seen at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins from 2005 to 2007. Place of residence was categorized into 3 nonoverlapping geographic areas: Baltimore City, non-Baltimore City catchment area, and non-catchment area. Controlling for age, sex, county poverty level, and cancer site, significant race and place of residence differences were seen in therapeutic or nontherapeutic clinical trials participation. White non-Baltimore City catchment area residents, the designated reference group, achieved the highest participation rate. Although the test of interaction (control group compared with all others) was not significant, some race-geographic area group differences were detected. In therapeutic trials, most race-place of residence group levels were statistically lower and different from reference; in nontherapeutic trials, race-specific Baltimore City groups participated at levels similar to reference. Baltimore City residents had lower participation rates only in therapeutic trials, irrespective of race. County poverty level was not significant but was retained as a confounder. Place of residence and race were found to be significant predictors of participation in therapeutic and nontherapeutic clinical trials, although patterns differed somewhat between therapeutic and nontherapeutic trials. Clinical trial accruals are not uniform across age, sex, race, place of residence, cancer site, or trial type, underscoring that cancer centers must better understand their source patients to enhance clinical trial participation.

Do Patients and Oncologists Discuss the Cost of Cancer Treatment? An Observational Study of Clinical Interactions Between African American Patients and Their Oncologists.

PURPOSE: Financial toxicity negatively affects patients with cancer, especially racial/ethnic minorities. Patient-oncologist discussions about treatment-related costs may reduce financial toxicity by factoring costs into treatment decisions. This study investigated the frequency and nature of cost discussions during clinical interactions between African American patients and oncologists and examined whether cost discussions were affected by patient sociodemographic characteristics and social support, a known buffer to perceived financial stress. Methods Video recorded patient-oncologist clinical interactions (n = 103) from outpatient clinics of two urban cancer hospitals (including a National Cancer Institute-designated comprehensive cancer center) were analyzed. Coders studied the videos for the presence and duration of cost discussions and then determined the initiator, topic, oncologist response to the patient's concerns, and the patient's reaction to the oncologist's response. RESULTS: Cost discussions occurred in 45% of clinical interactions. Patients initiated 63% of discussions; oncologists initiated 36%. The most frequent topics were concern about time off from work for treatment (initiated by patients) and insurance (initiated by oncologists). Younger patients and patients with more perceived social support satisfaction were more likely to discuss cost. Patient age interacted with amount of social support to affect frequency of cost discussions within interactions. Younger patients with more social support had more cost discussions; older patients with more social support had fewer cost discussions. CONCLUSION: Cost discussions occurred in fewer than one half of the interactions and most commonly focused on the impact of the diagnosis on patients' opportunity costs rather than treatment costs. Implications for ASCO's Value Framework and design of interventions to improve cost discussions are discussed.

Relative dose intensity--improving treatment and outcomes in early-stage breast cancer: a retrospective study.

PURPOSE/OBJECTIVES: To determine the amount of chemotherapy delivered compared to amount of chemotherapy scheduled by calculating relative dose intensity (RDI) and to identify factors associated with nonadherence of scheduled treatment regimens for patients with early-stage breast cancer (ESBC). DESIGN: Retrospective, descriptive, correlational study. SETTING: Two community hospital cancer centers in northern Michigan. SAMPLE: 77 patients with ESBC receiving adjuvant chemotherapy. METHODS: The RDI Calculator™ was used for data collection. A worksheet was developed for each patient and included characteristics, treatment information, and RDI calculations. SAS®, version 19.2, was used for multivariate analyses based on logistical regression analyzing relationships among dependent and independent variables. MAIN RESEARCH VARIABLES: Dependent variables were RDI prescribed and RDI received. Independent variables included chemotherapy regimen, clinical characteristics, planned dose, and schedule. FINDINGS: The average RDI was 86.6%. The average RDI was 86.7% for patients younger than age 65, and 85.5% for those 65 and older. The most common reasons for dose reduction or dose delay were treatment toxicity, chronic disease risk factors, age, unplanned versus planned treatment dose, institution (different standards of care), patient preference, and weight. CONCLUSIONS: Meeting treatment goals of RDI for patients with ESBC has been shown to increase the disease-free survival rate and positively affects overall survival. IMPLICATIONS FOR NURSING: Nurses have the unique opportunity to case manage patients with ESBC throughout the spectrum of care. One of the key areas of focus is education of the patient and her family members from the time of diagnosis throughout treatment and rehabilitation.

The impact of insurance on access to cancer clinical trials at a comprehensive cancer center.

PURPOSE: Cancer patients at Johns Hopkins undergo insurance clearance to verify coverage for enrollment to interventional clinical trials. We sought to explore the impact of insurance clearance on disparities in access to cancer clinical trials at this urban comprehensive cancer center. EXPERIMENTAL DESIGN: We evaluated the frequency of insurance-based denial of access to cancer clinical trials over a 5-year period after initiation of a formal insurance clearance process. We used a case-control design to compare demographic and clinical parameters of patients denied or approved for clinical trials participation by their insurance company in a 3-year interval. RESULTS: From July 2003 to July 2008, insurance requests for clinical trial participation were submitted on 4,617 consented cancer patients at Johns Hopkins. A total of 628 patients (13.6%) with health insurance were denied therapeutic trial enrollment owing to lack of insurance coverage for participation. A total of 254 patients denied enrollment from 2005 to 2007 were selected for further analysis. Two-hundred sixty randomly selected patients approved for clinical trial participation served as controls. Patients approved were on average older (59.2 versus 54.9 years) than patients denied (P = 0.0001). Residents of Pennsylvania, which lacks a state law mandating cancer clinical trial coverage for residents, were overrepresented among the denied patients (P = 0.0009). No statistically significant variance in the likelihood of insurance denial was found on the basis of sex, race, stage of disease, or presence of comorbidities. CONCLUSIONS: Denial of access to therapeutic clinical trials, even among insured patients, is a significant barrier to clinical cancer research. This barrier spans racial, ethnic, and gender categories.

Optimizing the dose and schedule of anti-vascular endothelial growth factor antibodies in non-small-cell lung cancer.

Lung cancer is the world's leading cause of cancer death. Most patients with non-small-cell lung cancer (NSCLC) present with advanced disease. Median survival is approximately 8-10 months for patients who receive standard platinum-based doublet therapy. In 2006 the FDA approved the anti-vascular endothelial growth factor (VEGF) antibody bevacizumab for patients with advanced, non-squamous, NSCLC based on the Eastern Cooperative Oncology Group E4599 trial. This trial demonstrated a 2-month improvement in overall survival when bevacizumab was added to carboplatin/paclitaxel. European investigators presented further data supporting improvement in progression-free survival with the use of bevacizumab and a cisplatin doublet in the Avastin in Lung Cancer (AVAiL) trial. Bevacizumab at doses of 7.5 mg/kg and 15 mg/kg are both effective and safe for patients with advanced NSCLC. Fatal hemorrhage has been reported for patients receiving the antiangiogenesis antibody. According to a retrospective study, the only significant clinical and radiographic variable associated with increased risk of pulmonary hemorrhage is the presence of cavitation. Common side effects include hypertension, proteinuria and minor mucosal bleeding. Bevacizumab monotherapy given every 21 days can be safely continued for patients without evidence of progression and for whom side effects of therapy are acceptable. Many questions remain, such as the role of the anti-VEGF antibody in early-stage disease, the safety of bevacizumab in patients with squamous histology NSCLC, and the benefit of combination therapy in elderly patients.