Patrick J. Coyne

Randomized Clinical Trial of an Implantable Drug Delivery System Compared With Comprehensive Medical Management for Refractory Cancer Pain: Impact on Pain, Drug-Related Toxicity, and Survival

PURPOSE Implantable intrathecal drug delivery systems (IDDSs) have been used to manage refractory cancer pain, but there are no randomized clinical trial (RCT) data comparing them with comprehensive medical management (CMM). PATIENTS AND METHODS We enrolled 202 patients on an RCT of CMM versus IDDS plus CMM. Entry criteria included unrelieved pain (visual analog scale [VAS] pain scores >/= 5 on a 0 to 10 scale). Clinical success was defined as >/= 20% reduction in VAS scores, or equal scores with >/= 20% reduction in toxicity. The main outcome measure was pain control combined with change of toxicity, as measured by the National Cancer Institute Common Toxicity Criteria, 4 weeks after randomization. RESULTS Sixty of 71 IDDS patients (84.5%) achieved clinical success compared with 51 of 72 CMM patients (70.8%, P =.05). IDDS patients more often achieved >/= 20% reduction in both pain VAS and toxicity (57.7% [41 of 71] v 37.5% [27 of 72], P =.02). The mean CMM VAS score fell from 7.81 to 4.76 (39% reduction); for the IDDS group, the scores fell from 7.57 to 3.67 (52% reduction, P =.055). The mean CMM toxicity scores fell from 6.36 to 5.27 (17% reduction); for the IDDS group, the toxicity scores fell from 7.22 to 3.59 (50% reduction, P =.004). The IDDS group had significant reductions in fatigue and depressed level of consciousness (P <.05). IDDS patients had improved survival, with 53.9% alive at 6 months compared with 37.2% of the CMM group (P =.06). CONCLUSION IDDSs improved clinical success in pain control, reduced pain, significantly relieved common drug toxicities, and improved survival in patients with refractory cancer pain.

Pain assessment in the patient unable to self-report: position statement with clinical practice recommendations.

Individuals who are unable to communicate their pain are at greater risk for under recognition and undertreatment of pain. This position paper describes the magnitude of this issue, defines populations at risk and offers clinical practice recommendations for appropriate pain assessment using a hierarchical framework for assessing pain in those unable to self-report. Nurses have a moral, ethical, and professional obligation to advocate for all individuals in their care, particularly those who are vulnerable and unable to speak for themselves. Just like all other patients, these special populations require consistent, ongoing assessment, appropriate treatment, and evaluation of interventions to insure the best possible pain relief. Because of continued advances and new developments in strategies and tools for assessing pain in these populations, clinicians are encouraged to stay current through regular review of new research and practice recommendations.

Nebulized Fentanyl Citrate Improves Patients' Perception of Breathing, Respiratory Rate, and Oxygen Saturation in Dyspnea

Dyspnea, a subjective symptom of impaired breathing, occurs in 70% of terminally ill cancer patients. Current treatments are suboptimal and little is known about the patients perception of effect. We tested nebulized inhaled fentanyl citrate on patient perceptions, respiratory rate, and oxygen saturation. The study was conducted using a convenience sample of 35 cancer patients on a dedicated oncology unit. We assessed patient perception (did breathing stay the same, worsen, or improve), respiratory rate, and oxygen saturation by pulse oximetry at baseline, 5 minutes, and 60 minutes. Twenty-six of 32 (81%) patients reported improvement in breathing, 3 (9%) were unsure, and 3 (9%) reported no improvement. Oxygen saturation improved from 94.6% at baseline to 96.8% at 5 minutes and 96.7% at 60 minutes (P = 0.0069 compared to baseline). Respiratory rates improved from a baseline of 28.4/min to 25.9/min at 5 minutes and 24.1/min at 60 minutes (P = 0.0251 compared to baseline). No side effects were observed. Inhaled nebulized fentanyl citrate significantly improved patient perception of breathing, respiratory rate, and oxygen saturation. This inexpensive and readily available treatment may offer substantial relief of end-of-life dyspnea. Randomized trials, dose, and length of effect trials are underway.

Pilot Trial of a Patient-Specific Cutaneous Electrostimulation Device (MC5-A Calmare®) for Chemotherapy-Induced Peripheral Neuropathy

CONTEXT Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting and persistent consequence of numerous classes of antineoplastic agents, affecting up to 30%-40% of patients. To date, there is no effective prevention or therapy. An evolving hypothesis for reducing CIPN pain involves direct nerve stimulation to reduce the pain impulse. OBJECTIVES To evaluate the impact on CIPN associated with the MC5-A Calmare® therapy device. METHODS The MC5-A Calmare® therapy device is designed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity. Sixteen patients from one center received one-hour interventions daily over 10 working days. RESULTS Of 18 patients, 16 were evaluable. The mean age of the patients was 58.6 years-four men and 14 women-and the duration of CIPN was three months to eight years. The most common drugs were taxanes, platinums, and bortezomib (Velcade, Millenium Pharmaceuticals, Cambridge MA). At the end of the study (Day 10), a 20% reduction in numeric pain scores was achieved in 15 of 16 patients. The pain score fell 59% from 5.81±1.11 before treatment to 2.38±1.82 at the end of 10 days (P<0.0001 by paired t-test). A daily treatment benefit was seen with a strong statistically significant difference between the pre- and post-daily pain scores (P<0.001). Four patients had their CIPN reduced to zero. A repeated-measures analysis using the scores from all 10 days confirmed these results. No toxicity was seen. Some responses have been durable without maintenance. CONCLUSION Patient-specific cutaneous electrostimulation with the MC5-A Calmare® device appears to dramatically reduce pain in refractory CIPN patients with no toxicity. Further studies are underway to define the benefit, mechanisms of action, and optimal schedule.

Nurses' Perceptions of Educational Gaps in Delivering End-of-Life Care

PURPOSE/OBJECTIVES To assess end-of-life (EOL) care core competencies deemed most important with corresponding educational needs from oncology nurses and to describe the characteristics of the respondents that are associated with selection of the top-ranked core competencies. DESIGN Descriptive, cross-sectional study. SETTING Mailed and online surveys. SAMPLE 714 members of the Oncology Nursing Society from Georgia, Virginia, Washington, and Wisconsin. METHODS Responses to a mailed or e-mailed researcher-developed questionnaire during a six-month period were collated and analyzed. MAIN RESEARCH VARIABLES Ranking of EOL care core competencies and perceived gaps in EOL continuing education. FINDINGS Almost all of the respondents indicated that EOL care was a part of their practice and that continuing education was important, but more than half of the respondents had fewer than two hours of continuing education regarding EOL care in the past two years. Twenty-five percent of the respondents do not believe they are adequately prepared to effectively care for a dying patient. Symptom management was the top-rated core competency, consistent across age, education level, practice role, and practice setting. How to talk to patients and families about dying and what comprises palliative care also was selected frequently. CONCLUSIONS Symptom management is the number one core competency, and the quantity and quality of EOL continuing education is inadequate. Educational gaps exist in EOL nursing care. IMPLICATIONS FOR NURSING Assessing what nurses believe to be leading EOL core competencies is useful in improving educational curricula along with considering characteristics of nurses when planning EOL educational programs.

Global efforts to improve palliative care: the International End‐of‐Life Nursing Education Consortium Training Programme

AIM This paper is a report of an evaluation study to determine the feasibility and effectiveness of the End-of-Life Nursing Education Consortium-International training conference in providing education and support materials to participants so they might return to their home countries and disseminate palliative care information. BACKGROUND More than 50 million people die each year, many without access to adequate pain control or palliative care. Numerous barriers to implementation of palliative care exist, including lack of education provided to healthcare professionals regarding these principles. Because they spend the most time with patients and their families, nurses have the greatest potential to change the way palliative care is provided. METHOD A Course Evaluation Form and a Postcourse Activity Evaluation was completed by a convenience sample of 38 nurses from 14 Eastern and Central European, former Soviet, and Central Asian countries. The data were collected in 2006 using Likert scales and open-ended questions. FINDINGS Evaluations of speakers ranged from a mean of 4.4 to 4.9 on the 5-point scale, with five denoting the highest level. The mean rating of the conference overall was 4.9. Strengths included the professional level of presentations, practical, clinically based content, extensive resources and availability of the educators. CONCLUSION The first End-of-Life Nursing Education Consortium-International training programme demonstrated the feasibility of providing high-quality, essential education to nurses from a variety of countries. Because End-of-Life Nursing Education Consortium is designed as a train-the-trainer programme, assistance with translation to native languages, along with textbooks and other resources, is needed to allow participants to fully implement this curriculum.

Oncology End-of-Life Nursing Education Consortium training program: improving palliative care in cancer.

PURPOSE/OBJECTIVES To describe an evaluation of the oncology version of the End-of-Life Nursing Education Consortium (ELNEC-Oncology) training program, which is designed to provide oncology nurses with the knowledge and materials necessary to disseminate palliative care information to their colleagues in local chapters of the Oncology Nursing Society (ONS). DATA SOURCES Participant reports. DATA SYNTHESIS 124 nurses representing 74 ONS chapters attended the first two courses. Dyads of ONS members from local chapters applied to attend ELNEC and completed surveys regarding their goals and expectations for implementing end-of-life (EOL) education and training after completion of the program. Participants educated more than 26,000 nurses after attending the program, including 7,593 nurses within their ONS chapters and 18,517 colleagues within their workplaces. Barriers to implementation included a lack of funding and time constraints. Participants sought additional palliative care learning opportunities, including attending other workshops, subscribing to palliative care journals, and becoming involved in committees focused on palliative care. CONCLUSION The ELNEC-Oncology program is a national collaboration with ONS that provides oncology nurses with the tools and expertise to effectively disseminate palliative care content to colleagues within their local chapters and work settings. IMPLICATIONS FOR NURSING EOL care information remains critical to the science of oncology nursing, and ELNEC-Oncology provides an effective strategy for disseminating the information.

A Trial of Scrambler Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy

ABSTRACT Neuropathic pain is common among cancer patients and often difficult to treat. This study used Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device, to treat cancer patients with pain. Patients received Scrambler therapy for 10 sessions (one daily) over a two-week period. The primary outcome was changed in pain numerical rating scale (NRS) at one month; secondary outcomes were changes in the Brief Pain Inventory and European Organization for Treatment and Cancer QLC-CIPN-20(EORTC CIPN-20), over time. Thirty-nine patients, mean age 56.5 yr, 16 men and 23 women, were treated over an 18-month period for an average of 9.3 days each. The “now” pain scores reduced from 6.6 before treatment to 4.5 at 14 days, 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively ( p < 0.001). Clinically important and statistically significant improvements were seen in average, least, and worst pain; BPI interference with life scores, and motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed. In this single arm trial, Scrambler therapy appeared to relieve cancer-associated chronic neuropathic pain both acutely and chronically, and provided sustained improvements in many indicators of quality of life.

A Randomized, Placebo Controlled Trial of Oral Zinc for Chemotherapy-Related Taste and Smell Disorders

ABSTRACT Abnormalities in taste and smell are commonly reported in patients receiving chemotherapy and may hinder appetite, dietary intake, nutritional well-being, and quality of life. Oral zinc has been used to treat taste and smell abnormalities in several altered physiologic states, including renal failure, liver disease, head trauma, and pregnancy, with varying results. The authors conducted a double-blinded, placebo-controlled randomized clinic trial over 3 months. Eligible patients were those taking chemotherapy that had alterations in taste and/or smell. The measurement of the primary end point, improvement in altered taste and smell, was made using a 0–100 scale (100 describing no loss or distortion in taste and smell, and 0 describing the worst distortion or loss of taste and smell). Twenty-nine subjects were enrolled in each treatment group, of whom 31 were white, 26 African American, and 1 Native American. Forty-one patients were female. A wide range of cancer types was represented, with breast the most common (21 patients). The zinc dose was 220 mg orally twice daily (equivalent of 50 mg elemental zinc twice daily). There was no statistically significant improvement in loss or distortion of taste or smell with the addition of zinc. There was a trend toward improvement over time in all groups, except in the zinc group where there was a nonsignificant worsening in loss of smell over time. Zinc at standard doses did not provide significant benefit to taste or smell in patients receiving chemotherapy.

Evaluation of palliative care nursing education seminars

PURPOSE More than 50 million people die each year around the world. Nurses are crucial in providing care to these individuals and their families as they spend the most time at the bedside with patients and families. Yet many nurses have received little or no education about palliative care. METHODS/SAMPLE The Open Society Institute (OSI) and the Open Medical Institute (OMI) partnered with End-of-Life Nursing Education Consortium (ELNEC) to develop an international nursing palliative care curriculum. This international curriculum was implemented with two training courses held in Salzburg, Austria in October 2006 (n=38) and April 2008 (n=39) representing 22 Eastern European/Central Asian countries. Participants were asked to establish goals in disseminating the palliative care information when they returned to their country. The participants were mentored/followed for a 12-month period to evaluate their palliative care knowledge as well as challenges encountered. KEY RESULTS The participants provided excellent ratings for the training courses indicating that the courses were stimulating and met their expectations. The 12-month follow-up demonstrated many challenges (i.e., lack of funds, institutional support, fear of death), in advancing palliative care within each participants setting/country as well as many examples of successful implementation. CONCLUSIONS There is an urgent need for improved palliative care throughout the world. The ELNEC-International curriculum is designed to address the need for increased palliative care education in nursing. In order to improve the quality of life for those facing life-threatening illnesses around the world, ongoing support is needed for world-wide palliative care educational efforts.