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Cho Y. Lam, Jennifer A. Minnix, Jason D. Robinson and Paul M. Cinciripini

The U.S. Department of Health and Human Services' Clinical Practice Guidelines have established both nicotine and nonnicotine-based pharmacotherapies as efficacious treatments for smoking cessation. Smokers attempting to quit smoking can significantly increase their chances by using one of several first-line agents, including nicotine transdermal patches, gum, nasal spray, inhalers, tablets, and the antidepressant bupropion. Those who cannot use either bupropion or nicotine replacement therapy because of contraindications or lack of effectiveness may benefit from the second-line treatment nortriptyline. This article also discusses several novel compounds for smoking cessation.

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Zeeshan Butt, Sarah K. Rosenbloom, Amy P. Abernethy, Jennifer L. Beaumont, Diane Paul, Debra Hampton, Paul B. Jacobsen, Karen L. Syrjala, Jamie H. Von Roenn and David Cella

Cancer fatigue has been defined and described as an important problem. However, few studies have assessed the relative importance of fatigue compared with other patient symptoms and concerns. To explore this issue, the authors surveyed 534 patients and 91 physician experts from 5 NCCN member institutions and community support agencies. Specifically, they asked patients with advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, or prostate cancer or lymphoma about their “most important symptoms or concerns to monitor.” Across the entire sample, and individually for patients with 9 cancer types, fatigue emerged as the top-ranked symptom. Fatigue was also ranked most important among patients with 10 of 11 cancer types when asked to rank lists of common concerns. Patient fatigue ratings were most strongly associated with malaise (r = 0.50) and difficulties with activities of daily living, pain, and quality of life. Expert ratings of how much fatigue is attributable to disease versus treatment mostly suggested that both play an important role, with disease-related factors predominant in hepatobiliary and lung cancer, and treatment-related factors playing a stronger role in head and neck cancer.

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Barbara Burtness, Milan Anadkat, Surendra Basti, Miranda Hughes, Mario E. Lacouture, Joan S. McClure, Patricia L. Myskowski, Jennifer Paul, Clifford S. Perlis, Leonard Saltz and Sharon Spencer

This NCCN Task Force Report describes the management of dermatologic and ocular toxicities that occur in patients treated with epidermal growth factor receptor (EGFR) inhibitors. Task force members are from NCCN member institutions and include oncologists, dermatologists, an ophthalmologist, and a mid-level oncology provider. This report describes commonly used therapies that the task force agreed are appropriate standards of care for dermatologic and ophthalmologic toxicities associated with EGFR inhibitors, which generally are supported only by anecdotal evidence. Few recommendations are evidence based; however, some commonly used therapies have data supporting their use. Conclusions from completed clinical trials are generally limited by the small numbers of patients enrolled. The information in this report is based on available published data on treating toxicities associated with EGFR inhibitors, data from treatment of clinically similar toxicities from different etiologies, and expert opinion among the NCCN Task Force members.

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Elizabeth A. Rohan, Beth Slotman, Amy DeGroff, Kerry Grace Morrissey, Jennifer Murillo and Paul Schroy

Background: Oncology patient navigators help individuals overcome barriers to increase access to cancer screening, diagnosis, and timely treatment. This study, part of a randomized intervention trial investigating the efficacy of patient navigation in increasing colonoscopy completion, examined navigators' activities to ameliorate barriers to colonoscopy screening in a medically disadvantaged population. Methods: This study was conducted from 2012 through 2014 at Boston Medical Center. We analyzed navigator service delivery and survey data collected on 420 participants who were navigated for colonoscopy screening after randomization to this intervention. Key variables under investigation included barriers to colonoscopy, activities navigators undertook to reduce barriers, time navigators spent on each activity and per contact, and patient satisfaction with navigation services. Descriptive analysis assessed how navigators spent their time and examined what aspects of patient navigation were most valued by patients. Results: Navigators spent the most time assessing patient barriers/needs; facilitating appointment scheduling; reminding patients of appointments; educating patients about colorectal cancer, the importance of screening, and the colonoscopy preparation and procedures; and arranging transportation. Navigators spent an average of 44 minutes per patient. Patients valued the navigators, especially for providing emotional/peer support and explaining screening procedures and bowel preparation clearly. Conclusions: Our findings help clarify the role of the navigator in colonoscopy screening within a medically disadvantaged community. These findings may help further refine the navigator role in cancer screening and treatment programs as facilities strive to effectively and efficiently integrate navigation into their services.

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John M. Salsman, Steven M. Grunberg, Jennifer L. Beaumont, Miriam Rogers, Diane Paul, Marla L. Clayman and David Cella

Despite recent progress, chemotherapy-induced nausea and vomiting (CINV), especially delayed CINV, continues to be a problem. Delayed CINV is underestimated and perceived differently by providers and patients. Communication between providers and patients about this side effect may help improve outcomes. This study identifies patients’ and providers’ perceptions of management and barriers to quality CINV care. Provider and patient versions of a Nausea and Vomiting Management Barriers Questionnaire were developed to address potential barriers. Providers and patients were given opportunities to add detail in open-ended questions. Providers were recruited through the NCCN and the Oncology Nursing Society mailing lists. Patients who received at least 2 cycles of chemotherapy and experienced CINV were recruited through a consortium of advocacy groups. Both providers (n = 141) and patients (n = 299) completed the survey. Providers (41%) and patients (42%) agreed medication side effects were a concern, but more patients (63%) than providers (36%) tried to limit the number of medications taken (P < .0001). Many providers (67%) spontaneously reported barriers to managing CINV, with financial and patient-related factors among the most common. Few patients (10%) reported cost as a barrier, but 37% endorsed the desire “to be strong by not complaining.” Barriers to communication and quality care of CINV differ between caregivers and patients. Addressing misconceptions and establishing mutually consistent goals will lead to more effective overall care.

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David Cella, Sarah K. Rosenbloom, Jennifer L. Beaumont, Susan E. Yount, Diane Paul, Debra Hampton, Amy P. Abernethy, Paul B. Jacobsen, Karen Syrjala and Jamie H. Von Roenn

Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

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Apostolia M. Tsimberidou, Alexandra M. Adamopoulos, Yang Ye, Sarina Piha-Paul, Filip Janku, Siqing Fu, David Hong, Gerald S. Falchook, Aung Naing, Jennifer Wheler, Adoneca Fortier, Razelle Kurzrock and Kenneth R. Hess

Bendamustine, a cytotoxic alkylating agent, has shown promising results in solid tumors. An investigator-initiated phase I clinical trial of the anti-vascular endothelial growth factor agent bevacizumab and bendamustine was conducted in patients with advanced cancer, because the 2 drugs have different mechanisms of antitumor activity and nonoverlapping toxicity. Patients were treated with escalating doses of intravenous bendamustine (70, 80, 90, and 100 mg/m2; days 1 and 2) and intravenous bevacizumab (10 mg/kg; days 1 and 15). A conventional “3 + 3” study design was used. Forty-two patients were treated: 23 women and 19 men. The median age was 60 years. Patients had received a median of 4 prior therapies (range, 1-10). The most common cancer types were colorectal (n=9), head and neck (n= 8), non-small cell lung (n=6), and breast (n=5). Overall, 117 cycles were administered (median per patient, 2; range, 1-8). No dose-limiting toxicities were noted during the escalation phase. Therefore, the highest dose (level 4) of bendamustine (100 mg/m2) was used in the expansion phase. The most common toxicities were fatigue (n=22), nausea (n=14), anorexia (n=9), and thrombocytopenia (n=7). Of 38 patients who were evaluable for response, 23 (61%) had stable disease, including 2 (5.2%) who had stable disease for 6 months or more (1 with adenoid cystic carcinoma and 1 with non-small cell lung cancer). This regimen of bendamustine (100 mg/m2) and bevacizumab (10 mg/kg) was well tolerated and yielded disease stabilization in selected heavily pretreated patients with advanced cancer.

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Matthew P. Banegas, K. Robin Yabroff, Maureen C. O'Keeffe-Rosetti, Debra P. Ritzwoller, Paul A. Fishman, Ramzi G. Salloum, Jennifer Elston Lafata and Mark C. Hornbrook

Background: The high economic burden of cancer is projected to continue growing. Cost-of-care estimates are key inputs for comparative effectiveness and economic analyses that aim to inform policies associated with cancer care. Existing estimates are based largely on SEER-Medicare data in the elderly, leaving a knowledge gap regarding costs for patients aged <65 years. Methods: We estimated total and net medical care costs using data on individuals diagnosed with breast, colorectal, lung, or prostate cancer (n=45,522) and noncancer controls (n=314,887) enrolled in 1 of 4 participating health plans. Net costs were defined as the difference in mean total costs between patients with cancer and controls. The phase-of-care approach and Kaplan-Meier Sample Average method were used to estimate mean total and net 1- and 5-year costs (in 2015 US dollars) by cancer site, stage at diagnosis, and age group (<65 and ≥65 years). Results: Total and net costs were consistently highest for lung cancer and lowest for prostate cancer. Net costs were higher across all cancer sites for patients aged <65 years than those aged ≥65 years. Medical care costs for all cancers increased with advanced stage at diagnosis. Conclusions: This study improves understanding of medical care costs for the 4 most common invasive cancers in the United States. Higher costs among patients aged <65 years highlight limitations of relying on SEER-Medicare data alone to understand the national burden of cancer, whereas higher costs for patients with advanced-stage cancer underscore the importance of early detection to curtail high long-term costs. These cost estimates can be used in the development and evaluation of interventions and policies across the cancer care continuum.

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Matthew H. Kulke, Manisha H. Shah, Al B. Benson III, Emily Bergsland, Jordan D. Berlin, Lawrence S. Blaszkowsky, Lyska Emerson, Paul F. Engstrom, Paul Fanta, Thomas Giordano, Whitney S. Goldner, Thorvardur R. Halfdanarson, Martin J. Heslin, Fouad Kandeel, Pamela L. Kunz, Boris W. Kuvshinoff II, Christopher Lieu, Jeffrey F. Moley, Gitonga Munene, Venu G. Pillarisetty, Leonard Saltz, Julie Ann Sosa, Jonathan R. Strosberg, Jean-Nicolas Vauthey, Christopher Wolfgang, James C. Yao, Jennifer Burns and Deborah Freedman-Cass

Neuroendocrine tumors (NETs) comprise a broad family of tumors that may or may not be associated with symptoms attributable to hormonal hypersecretion. The NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine Tumors discuss the diagnosis and management of both sporadic and hereditary NETs. This selection from the guidelines focuses on sporadic NETs of the pancreas, gastrointestinal tract, lung, and thymus.

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Ryan D. Nipp, Leah L. Thompson, Brandon Temel, Charn-Xin Fuh, Christine Server, Paul S. Kay, Sophia Landay, Daniel E. Lage, Lara Traeger, Erin Scott, Vicki A. Jackson, Nora K. Horick, Joseph A. Greer, Areej El-Jawahri and Jennifer S. Temel

Background: Oncologists often struggle with managing the complex issues unique to older adults with cancer, and research is needed to identify patients at risk for poor outcomes. Methods: This study enrolled patients aged ≥70 years within 8 weeks of a diagnosis of incurable gastrointestinal cancer. Patient-reported surveys were used to assess vulnerability (Vulnerable Elders Survey [scores ≥3 indicate a positive screen for vulnerability]), quality of life (QoL; EORTC Quality of Life of Cancer Patients questionnaire [higher scores indicate better QoL]), and symptoms (Edmonton Symptom Assessment System [ESAS; higher scores indicate greater symptom burden] and Geriatric Depression Scale [higher scores indicate greater depression symptoms]). Unplanned hospital visits within 90 days of enrollment and overall survival were evaluated. We used regression models to examine associations among vulnerability, QoL, symptom burden, hospitalizations, and overall survival. Results: Of 132 patients approached, 102 (77.3%) were enrolled (mean [M] ± SD age, 77.25 ± 5.75 years). Nearly half (45.1%) screened positive for vulnerability, and these patients were older (M, 79.45 vs 75.44 years; P=.001) and had more comorbid conditions (M, 2.13 vs 1.34; P=.017) compared with nonvulnerable patients. Vulnerable patients reported worse QoL across all domains (global QoL: M, 53.26 vs 66.82; P=.041; physical QoL: M, 58.95 vs 88.24; P<.001; role QoL: M, 53.99 vs 82.12; P=.001; emotional QoL: M, 73.19 vs 85.76; P=.007; cognitive QoL: M, 79.35 vs 92.73; P=.011; social QoL: M, 59.42 vs 82.42; P<.001), higher symptom burden (ESAS total: M, 31.05 vs 15.00; P<.001), and worse depression score (M, 4.74 vs 2.25; P<.001). Vulnerable patients had a higher risk of unplanned hospitalizations (hazard ratio, 2.38; 95% CI, 1.08–5.27; P=.032) and worse overall survival (hazard ratio, 2.26; 95% CI, 1.14–4.48; P=.020). Conclusions: Older adults with cancer who screen positive as vulnerable experience a higher symptom burden, greater healthcare use, and worse survival. Screening tools to identify vulnerable patients should be integrated into practice to guide clinical care.