Charles F. von Gunten

Palliative Cancer Care a Decade Later: Accomplishments, the Need, Next Steps--From the American Society of Clinical Oncology

PURPOSE In 1998, the American Society of Clinical Oncology (ASCO) published a special article regarding palliative care and companion recommendations. Herein we summarize the major accomplishments of ASCO regarding palliative cancer and highlight current needs and make recommendations to realize the Societys vision of comprehensive cancer care by 2020. METHODS ASCO convened a task force of palliative care experts to assess the state of palliative cancer care in the Societys programs. We reviewed accomplishments, assessed current needs, and developed a definition of palliative cancer. Senior ASCO members and the Board of Directors reviewed and endorsed this article for submission to Journal of Clinical Oncology. RESULTS Palliative cancer care is the integration into cancer care of therapies that address the multiple issues that cause suffering for patients and their families and impact their life quality. Effective provision of palliative cancer care requires an interdisciplinary team that can provide care in all patient settings, including outpatient clinics, acute and long-term care facilities, and private homes. Changes in current policy, drug availability, and education are necessary for the integration of palliative care throughout the experience of cancer, for the achievement of quality improvement initiatives, and for effective palliative cancer care research. CONCLUSION The need for palliative cancer care is greater than ever notwithstanding the strides made over the last decade. Further efforts are needed to realize the integration of palliative care in the model and vision of comprehensive cancer care by 2020.

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

IMPORTANCE For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were

Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Advanced Illness: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study

3.37 per day and

Textbook of Palliative Medicine

716 per patient. CONCLUSIONS AND RELEVANCE This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01415934.

Clinical management of dyspnoea

Methylnaltrexone, a peripherally-acting quaternary opioid antagonist, is an investigational treatment for opioid-induced constipation in patients with advanced illness. This randomized, parallel-group, repeated dose, dose-ranging trial included a double-blind phase for one week followed by an open-label phase for a maximum of three weeks. Opioid-treated patients with advanced illness who met criteria for opioid-induced constipation despite laxative therapy were potentially eligible. Double-blind treatment occurred on Days 1, 3, and 5; open-label therapy could be administered as often as every other day. The initial dose range of 1mg, 5mg, or 12.5mg was extended by adding a 20mg group during the study while still maintaining the double blind; the initial open-label dose of 5mg could be titrated. The primary outcome was a laxation response within four hours after the first dose. Thirty-three patients received at least one dose of methylnaltrexone. Only one of 10 patients (10%) who received the 1mg dose experienced laxation within four hours of dosing. The median time to laxation was >48 hours for the 1mg dose group, compared to 1.26 hours for all patients receiving >or=5mg (P=0.0003). There was no apparent dose-response above 5mg. Most adverse events were related to the gastrointestinal system, were mild, and did not lead to discontinuation. In conclusion, methylnaltrexone relieved opioid-induced constipation at doses >or=5mg in patients with advanced illness, and did not reduce analgesia or cause opioid withdrawal symptoms.

Current status of palliative care--clinical implementation, education, and research.

PART 1 The development of palliative medicine in: the UK and Ireland Europe Canada the USA Latin America Africa Australia and New Zealand Asia Palliative care versus palliative medicine Palliative care as a public heath issue The future of palliative medicine PART 2 Principles of bioethics Ethics Dignity PART 3 Dying in different cultures Palliative care global initiatives PART 4 Undergraduate Graduate Postgraduate and continuing education Public education PART 5 Challenges of research The patient population Research designs Outcomes Ethics in research Practical tips for successful research Audit and quality improvement PART 6 Standards of care The engineering of organizational change Financial issues in the delivery of palliative care Organization and support of the multiprofessional / interdisciplinary team Needs assessment for patient care The palliative care consult team Models for palliative care delivery Home care Day hospitals Inpatient hospices The palliative care unit Combined care models PART 7 Patient assessment Tools for pain and symptom assessment Quality of life assessment PART 8 The pathophysiology of chronic pain Causes & mechanisms of pain Opioid analgesics The assessment and management of opioid side effects Adjuvant analgesic drugs Alternative routes for systemic opiod delivery Epidural & intrathecal administration Topical administration of analgesics Non-pharmacological and non-invasive management of pain Pain in children Pain in the elderly Neuropathic pain Bone pain Incidental pain Somatization and pain expression Pain in patients with alcohol and drug dependence PART 9 Pathophysiology of anorexia-cachexia Nutritional and phamacological management of cachexia Nausea/vomiting Constipation/diarrhea Ascites Jaundice Bowel obstruction The endoscopic treatment of gastrointestinal symptoms PART 10 The pathophysiology of fatigue Assessment of fatigue The role of physical function on fatigue The treatment of fatigue PART 11 Dyspnea Other respiratory symptoms PART 12 Depression/anxiety Confusion/delirium Sleeping disorders Counseling Hope PART 13 Dehydration and re-hydration Fever and sweating Pruritus Infections Pressure ulcers and wounds Mouth care Fistulas The assessment and management of lymphedema PART 14 Hypercalcemia Hemorrhage Spinal cord compression Superior venacava syndrome Seizures Acute pain syndromes Suicide PART 15 Radiotherapy Chemotherapy Physical medicine and rehabilitation Integrative and alternative medicine AIDS Neurological diseases Congestive heart failure & other causes of terminal heart disease Palliative care in children Chronic obstructive pulmonary disease & other terminal respiratory conditions Other infectious diseases Practical aspects of palliative care delivery in the developing world Prognostic indicators of survival Palliative sedation PART 16 Physiotherapy and occupational therapy Stress & burnout in health care givers Communication in palliative care Spiritual care Family care Advanced directives Bereavement Children of palliative care patients

Competency in End-of-Life Care: Last Hours of Life

Dyspnoea, defined as a sensation of an uncomfortable awareness of breathing, is one of the most frightening and distressing symptoms for patients with cancer. It is very common in cancer patients with and without direct lung involvement. The gold standard of diagnosis and assessment is the patients self-report. Measurements of respiratory rate, oxygen saturation, and arterial blood gases do not measure dyspnoea. Fast, safe, and effective relief of the symptom is possible whether or not identifiable reversible causes exist. Opioids are the first line of therapy for such relief. Medical management can be directed at the underlying cause when the potential benefits outweigh the burdens of such treatment. In rare cases for which symptomatic treatment does not control dyspnoea to the patients satisfaction, sedation is an effective, ethical option.

Knowledge: insufficient for change.

Palliative and end‐of‐life care is changing in the United States. This dynamic field is improving care for patients with serious and life‐threatening cancer through creation of national guidelines for quality care, multidisciplinary educational offerings, research endeavors, and resources made available to clinicians. Barriers to implementing quality palliative care across cancer populations include a rapidly expanding population of older adults who will need cancer care and a decrease in the workforce available to give care. Methods of integrating current palliative care knowledge into care of patients include multidisciplinary national education and research endeavors, and clinician resources. Acceptance of palliative care as a recognized medical specialty provides a valuable resource for improvement of care. Although compilation of evidence for the importance of palliative care specialities is in its initial stages, national research grants have provided support to build the knowledge necessary for appropriate palliative care. Opportunities are available to clinicians for understanding and applying appropriate palliative and end‐of‐life care to patients with serious and life‐threatening cancers. CA Cancer J Clin 2009;59:327–335.

Ensuring competency in end-of-life care: controlling symptoms

Clinical competence, willingness to educate, and calm and empathic reassurance are critical to helping patients and families in the last hours of living. This review adapted from the Education for Physicians on End-of-Life Care (EPEC) Curriculum describes the predictable course that occurs as well as approaches to management. Management principles are the same at home or in a health care institution. However, death in an institution requires accommodations to assure privacy, cultural observances, and communication that may not be customary. In anticipation of the event, it helps to inform the family and other professionals about what to do and what to expect. Care does not end until the family has been supported with their grief reactions and those with complicated grief helped to get care. Care at the end of life is a core competency.

Development of a Medical Subspecialty in Palliative Medicine: Progress Report

145 WE HAVE LEARNED (once again) that education alone does not change patient and family experience. Or, to be more precise, education targeted to improve knowledge and attitudes does not change behavior. Allard et al.1 analyzed 33 studies of educational interventions for cancer pain control. They found that attitudes and knowledge about cancer pain could be improved. Unfortunately there was minimal change in patient’s pain. The conclusions of Allard et al.1 will come as an unwelcome surprise to many. We can hear the moans now. “They didn’t look at enough studies.” “They didn’t do them right.” “I’m sure it is different in our education program.” Although the conclusions are discouraging, they shouldn’t be surprising. We have learned the same things from education about tobacco, alcohol, sex, diet, hand-washing, hypertension, advance directives, etc. The investigators who have reported their work in all of these areas suffer from a grand and prevalent delusion. They believe that knowledge alone changes behavior. As a professor of psychiatry once told one of us “Knowledge is the booby prize . . . it doesn’t change behavior.” We can understand what we do, why we do it and how we should do it better, but the information alone won’t lead to a change in behavior. More precisely, attitudes and knowledge are necessary, but insufficient, to change behavior. If it is our goal to change the patient and family experience, we need to adopt a more precise way of understanding education. Dixon described a cascade of steps of education evaluation that remains helpful.2 We have adapted this to assist our understanding of the components or steps of education (Fig. 1). Knowledge and attitudes precede the learning of new skills. Those skills must be translated into behavior if desired outcomes are to be seen. When enough people are experiencing the desired outcomes, there will be social improvement. If we use this framework to understand the necessary steps of cancer pain education, we would say that the attitude that “it is important to control cancer pain” and the knowledge of how to control it come first. Then the skills of assessing pain, prescribing appropriate medications and teaching patients and families must be learned. Then, the clinician must change his or her behavior and implement the knowledge, attitudes and skills on a permanent basis in order for the desired outcome. Patients must also change their attitudes, knowledge, skills and behavior to control cancer pain. When these behaviors are exhibited by both clinicians and patients, the outcome will be improved reports of pain by patients. When all patients with cancer pain get good relief, we will have achieved a social good. Fortunately, there is work afoot using this framework to achieve the desired ends. There are numerous projects to disseminate education about necessary attitudes and knowledge to health care professionals. The Role Model Project is a successful model for teaching pain management.3 The Education for Physicians on End-oflife Care (EPEC) Project focusses on the attitudes and knowledge of physicians.4 The End-of-Life Nursing Education Consortium (ELNEC) is focusing on the attitudes and knowledge of nurses.5