Ryan D. Nipp

The relationship between coping strategies, quality of life, and mood in patients with incurable cancer.

Patients with incurable cancer face many physical and emotional stressors, yet little is known about their coping strategies or the relationship between their coping strategies, quality of life (QOL), and mood.

Age and Gender Moderate the Impact of Early Palliative Care in Metastatic Non-Small Cell Lung Cancer

This study analyzed data from a randomized controlled trial of patients with metastatic non-small cell lung cancer who received either early palliative care (EPC) integrated with oncology care or oncology care alone. Males and younger patients who received EPC had better quality of life and mood than those who received oncology care alone. However, these outcomes did not differ significantly between treatment groups for females or older patients.

Impact of Age on Outcomes with Immunotherapy for Patients with Melanoma

BACKGROUND Monoclonal antibodies (mAb) targeting PD-1/PD-L1 have revolutionized melanoma treatment, yet data regarding effectiveness and tolerability across age groups is limited. We sought to determine the impact of age on overall survival (OS), progression-free survival (PFS), and rates of immune-mediated toxicities in patients treated with anti-PD-1/anti-PD-L1 mAb at two academic medical centers. METHODS We retrospectively collected data on all patients with metastatic melanoma treated with anti-PD-1/PD-L1 mAb between May 2009 and April 2015. We used Kaplan-Meier and Cox regression analyses to assess OS and PFS and identify factors associated with these outcomes. We also compared rates of autoimmune toxicity across age groups. RESULTS Of 254 patients, 57 (22.4%) were <50 years old, 85 (33.5%) were age 50-64, 65 (25.6%) were age 65-74, and 47 (18.5%) were ≥75 years. Across age groups, no differences existed in median OS (age <50: 22.9 months, age 50-64: 25.3 months, age 65-74: 22.0 months, age ≥75: 24.3 months) or PFS (age <50: 4.1 months, age 50-64: 6.5 months, age 65-74: 5.4 months, age ≥75: 7.9 months). The presence of liver metastases and elevated pre-treatment lactate dehydrogenase (LDH) were associated with reduced OS. Presence of liver metastasis, pretreatment LDH, BRAF mutation, and type of melanoma correlated with PFS. Overall, 110 patients (43.3%) experienced immune-mediated toxicities; 25 (9.8%) had colitis and 26 (10.2%) had endocrine toxicity. Rates of colitis, hepatitis, and pneumonitis did not differ across age groups. CONCLUSION We demonstrated that patients could safely tolerate anti-PD1/PDL-1 mAb therapy and achieve similar outcomes regardless of their age. IMPLICATIONS FOR PRACTICE Immunotherapy has revolutionized treatment for patients with metastatic melanoma, yet data are lacking regarding the effectiveness and tolerability of these treatments for older patients. In this study, we demonstrated that patients with melanoma safely tolerate immunotherapy and achieve similar outcomes regardless of their age. Specifically, we utilized data from two academic cancer centers and found no significant difference in overall survival, progression free survival, or immune-related toxicities, other than arthritis, across age groups. As the population ages, studies such as this will become critical to help us understand how best to treat older adults with cancer.

Identifying cancer patients who alter care or lifestyle due to treatment-related financial distress.

Cancer patients may experience financial distress as a side effect of their care. Little is known about which patients are at greatest risk for altering their care or lifestyle due to treatment‐related financial distress.

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

INTRODUCTION Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. METHODS We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. RESULTS After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). CONCLUSION CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. IMPLICATIONS FOR PRACTICE Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns.

Serum magnesium concentrations and metabolic variables in polycystic ovary syndrome.

Objective. Hypomagnesemia is associated with diabetes mellitus type 2 and other components of the metabolic syndrome in older patients. Whether serum magnesium concentrations correlate with insulin resistance, obesity, hypertension, dyslipidemia, or other components of metabolic syndrome in younger women with polycystic ovary syndrome (PCOS) is currently unknown. Design. Cross‐sectional analysis. Setting. Academic medical center. Population. 100 consecutive women with PCOS by the Rotterdam criteria and 20 age‐ and BMI‐matched normal women. Methods. Statistical analysis of the relationship between magnesium levels and a variety of physical, endocrine, and metabolic variables. The STROBE guidelines for a cross‐sectional analysis were followed. Main outcome measurements. Serum magnesium levels, insulin sensitivity indices, and glucose assessments. BMI, waist circumference, blood pressure, and lipids served as secondary endpoint measurements. Results. No patient demonstrated hypomagnesemia. Magnesium levels did not differ between women with and those without insulin resistance, glucose intolerance, or hypertension. Magnesium levels were similar across PCOS phenotypes and WHO‐defined BMI categories. Multiple regression analysis did not suggest that serum magnesium concentrations correlated with any physical, metabolic, or endocrine variable. Conclusions. Magnesium levels do not correspond with age, BMI, waist circumference, insulin sensitivity, glycemic levels, blood pressure, or lipid levels in reproductive‐age women with PCOS. Magnesium concentrations are similar across PCOS phenotypes and indistinguishable from women without PCOS.

Financial Burden in Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study

Purpose Survivors of childhood cancer may experience financial burden as a result of health care costs, particularly because these patients often require long-term medical care. We sought to evaluate the prevalence of financial burden and identify associations between a higher percentage of income spent on out-of-pocket medical costs (≥ 10% of annual income) and issues related to financial burden (jeopardizing care or changing lifestyle) among survivors of childhood cancer and a sibling comparison group. Methods Between May 2011 and April 2012, we surveyed an age-stratified, random sample of survivors of childhood cancer and a sibling comparison group who were enrolled in the Childhood Cancer Survivor Study. Participants reported their household income, out-of-pocket medical costs, and issues related to financial burden (questions were adapted from national surveys on financial burden). Logistic regression identified associations between participant characteristics, a higher percentage of income spent on out-of-pocket medical costs, and financial burden, adjusting for potential confounders. Results Among 580 survivors of childhood cancer and 173 siblings, survivors of childhood cancer were more likely to have out-of-pocket medical costs ≥ 10% of annual income (10.0% v 2.9%; P < .001). Characteristics of the survivors of childhood cancer that were associated with a higher percentage of income spent on out-of-pocket costs included hospitalization in the past year (odds ratio [OR], 2.3; 95% CI, 1.1 to 4.9) and household income <

CD38 variation as a prognostic factor in chronic lymphocytic leukemia

50,000 (OR, 5.5; 95% CI, 2.4 to 12.8). Among survivors of childhood cancer, a higher percentage of income spent on out-of-pocket medical costs was significantly associated with problems paying medical bills (OR, 8.9; 95% CI, 4.4 to 18.0); deferring care for a medical problem (OR, 3.0; 95% CI, 1.6 to 5.9); skipping a test, treatment, or follow-up (OR, 2.1; 95% CI, 1.1 to 4.0); and thoughts of filing for bankruptcy (OR, 6.6; 95% CI, 3.0 to 14.3). Conclusion Survivors of childhood cancer are more likely to report spending a higher percentage of their income on out-of-pocket medical costs, which may influence their health-seeking behavior and potentially affect health outcomes. Our findings highlight the need to address financial burden in this population with long-term health care needs.

Pragmatic study designs for older adults with cancer: Report from the U13 conference

CD38 is a membrane glycoprotein expressed to a variable extent in chronic lymphocytic leukemia (CLL), where elevated CD38 expression is associated with inferior clinical outcomes [1]. More than a p...

Role of Pain Medications, Consultants, and Other Services in Improved Pain Control of Elderly Adults with Cancer in Geriatric Evaluation and Management Units

Cancer is a disease occurring disproportionately in older adults. However, the evidence base regarding how best to care for these patients remains limited due to their underrepresentation in cancer clinical trials. Pragmatic clinical trials represent a promising approach for enhancing the evidence base in geriatric oncology by allowing investigators to enroll older, frailer patients onto cancer clinical trials. These trials are more accessible, less resource intensive, and place minimal additional burden on participating patients. Additionally, these trials can be designed to measure endpoints directly relevant to older adults, such as quality of life, functional independence and treatment tolerability which are often not addressed in standard clinical trials. Therefore, pragmatic clinical trials allow researchers to include patients for whom the treatment will ultimately be applied and to utilize meaningful endpoints. Examples of pragmatic studies include both large, simple trials and cluster randomized trials. These study designs allow investigators to conduct clinical trials within the context of everyday practice. Further, researchers can devise these studies to place minimal burden on the patient, the treating clinicians and the participating institutions. In order to be successful, pragmatic trials must efficiently utilize the electronic medical record for data capture while also maximizing patient recruitment, enrollment and retention. Additionally, by strategically utilizing pragmatic clinical trials to test therapies and interventions that have previously shown efficacy in younger, fitter patients, these trials represent a potential mechanism to improve the evidence base in geriatric oncology and enhance care for older adults with cancer.