Palliative Care for Patients With Cancer: ASCO Guideline Update.

PURPOSE: To provide evidence-based guidance to oncology clinicians, patients, nonprofessional caregivers, and palliative care clinicians to update the 2016 ASCO guideline on the integration of palliative care into standard oncology for all patients diagnosed with cancer. METHODS: ASCO convened an Expert Panel of medical, radiation, hematology-oncology, oncology nursing, palliative care, social work, ethics, advocacy, and psycho-oncology experts. The Panel conducted a literature search, including systematic reviews, meta-analyses, and randomized controlled trials published from 2015-2023. Outcomes of interest included quality of life (QOL), patient satisfaction, physical and psychological symptoms, survival, and caregiver burden. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS: The literature search identified 52 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS: Evidence-based recommendations address the integration of palliative care in oncology. Oncology clinicians should refer patients with advanced solid tumors and hematologic malignancies to specialized interdisciplinary palliative care teams that provide outpatient and inpatient care beginning early in the course of the disease, alongside active treatment of their cancer. For patients with cancer with unaddressed physical, psychosocial, or spiritual distress, cancer care programs should provide dedicated specialist palliative care services complementing existing or emerging supportive care interventions. Oncology clinicians from across the interdisciplinary cancer care team may refer the caregivers (eg, family, chosen family, and friends) of patients with cancer to palliative care teams for additional support. The Expert Panel suggests early palliative care involvement, especially for patients with uncontrolled symptoms and QOL concerns. Clinicians caring for patients with solid tumors on phase I cancer trials may also refer them to specialist palliative care.Additional information is available at www.asco.org/supportive-care-guidelines.

Palliative care utilization in calciphylaxis: a single-center retrospective review of 121 patients (1999-2016).

BACKGROUND: Calciphylaxis is a debilitating dermatological condition associated with high rates of morbidity and mortality. Palliative care offers a multidisciplinary approach to addressing symptoms and goals of care in patients with serious medical diagnoses. Involvement of palliative services for calciphylaxis is infrequently reported in the literature. The purpose of this report is to assess rates of palliative and pain consultation for patients with calciphylaxis. METHODS: This is a comprehensive, single-institution retrospective chart review of 121 eligible patients with a diagnosis of calciphylaxis treated at Mayo Clinic in Rochester, Minnesota, from 1999 to 2016. Inclusion criteria were an indisputable diagnosis of calciphylaxis based on clinical, histopathologic, and radiographic features. One hundred twenty-one patients met inclusion criteria. RESULTS: Fifty-one patients (42%) received either a palliative (n = 15) or pain (n = 20) consultation, or both (n = 16). Patients with a palliative care consultation were younger compared with those without (mean ages 57 vs. 62 years, P = 0.046). In 104 patients (86%), psychiatric symptoms were not assessed. CONCLUSIONS: In this cohort of patients with calciphylaxis, the majority do not receive palliative and pain care consultations. Psychiatric complications are inconsistently addressed. These observations highlight practice gaps in the care of patients with calciphylaxis.

Availability of Internationally Controlled Essential Medicines in the COVID-19 Pandemic.

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access.

Medical Students' Experiences and Outcomes Using a Virtual Human Simulation to Improve Communication Skills: Mixed Methods Study.

BACKGROUND: Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)-based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial. OBJECTIVE: This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication. METHODS: We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures-MPathic-VR-calculated scores and the objective structured clinical exam (OSCE) scores-with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis. RESULTS: OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F1,414=6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers. CONCLUSIONS: VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.

Palliative Care in the Global Setting: ASCO Resource-Stratified Practice Guideline.

Purpose The purpose of this new resource-stratified guideline is to provide expert guidance to clinicians and policymakers on implementing palliative care of patients with cancer and their caregivers in resource-constrained settings and is intended to complement the Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update of 2016. Methods ASCO convened a multidisciplinary, multinational panel of experts in medical oncology, family medicine, radiation oncology, hematology/oncology, palliative and/or hospice care, pain and/or symptom management, patient advocacy, public health, and health economics. Guideline development involved a systematic literature review, a modified ADAPTE process, and a formal consensus-based process with the Expert Panel and additional experts (consensus ratings group). Results The systematic review included 48 full-text publications regarding palliative care in resource-constrained settings, along with cost-effectiveness analyses; the evidence for many clinical questions was limited. These provided indirect evidence to inform the formal consensus process, which resulted in agreement of ≥ 75% (by consensus ratings group including Expert Panel). Recommendations The recommendations help define the models of care, staffing requirements, and roles and training needs of team members in a variety of resource settings for palliative care. Recommendations also outline the standards for provision of psychosocial support, spiritual care, and opioid analgesics, which can be particularly challenging and often overlooked in resource-constrained settings. Additional information is available at www.asco.org/resource-stratified-guidelines . It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Pain and Policy Studies Group: Two Decades of Working to Address Regulatory Barriers to Improve Opioid Availability and Accessibility Around the World.

For two decades, the Pain & Policy Studies Group (PPSG), a global research program at the University of Wisconsin Carbone Cancer Center, has worked passionately to fulfill its mission of improving pain relief by achieving balanced access to opioids worldwide. PPSG's early work highlighted the conceptual framework of balance leading to the development of the seminal guidelines and criteria for evaluating opioid policy. It has collaborated at the global level with United Nations agencies to promote access to opioids and has developed a unique model of technical assistance to help national governments assess regulatory barriers to essential medicines for pain relief and amend existing or develop new legislation that facilitates appropriate and adequate opioid prescribing according to international standards. This model was initially applied in regional workshops and individual country projects and then adapted for PPSG's International Pain Policy Fellowship, which provides long-term mentoring and support for several countries simultaneously. The PPSG disseminates its work online in several ways, including an extensive Web site, news alerts, and through several social media outlets. PPSG has become the focal point for expertise on policy governing drug control and medicine and pharmacy practice related to opioid availability and pain relief.

Significant suppression of radiation dermatitis in breast cancer patients using a topically applied adrenergic vasoconstrictor.

BACKGROUND: Our previous studies showed that vasoconstrictor applied topically to rat skin minutes before irradiation completely prevented radiodermatitis. Here we report on a Phase IIa study of topically applied NG12-1 vasoconstrictor to prevent radiodermatitis in post-lumpectomy breast cancer patients who received at least 40 Gray to the whole breast using standard regimens. METHODS: Patients had undergone surgery for Stage Ia, Ib, or IIa infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ. NG12-1 formulation was applied topically to the same 50-cm2 treatment site within the radiation field 20 min before each daily radiotherapy fraction. RESULTS: Scores indicated significant reductions in radiodermatitis at the NG12-1 treatment site versus control areas in the same radiotherapy field. The mean dermatitis score for all subjects was 0.47 (SD 0.24) in the NG12-1-treated area versus 0.72 (SD 0.22) in the control area (P = 0.022). Analysis by two independent investigators indicated radiodermatitis reductions in 9 of the 9 patients with scorable radiodermatitis severity, and one patient with insufficient radiodermatitis to enable scoring. There were no serious adverse events from NG12-1 treatment. CONCLUSIONS: Thirty, daily, NG12-1 treatments, topically applied minutes before radiotherapy, were well tolerated and conferred statistically significant reductions in radiodermatitis severity (P = 0.022). TRIAL REGISTRATION: NCT01263366 ; clinicaltrials.gov.

Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials.

BACKGROUND: Symptom distress in patients toward the end of life can change rapidly. Family caregivers have the potential to help patients manage those symptoms, as well as their own stress, if they are equipped with the proper resources. Electronic health (eHealth) systems may be able to provide those resources. Very sick patients may not be able to use such systems themselves to report their symptoms but family caregivers could. OBJECTIVE: The aim of this paper was to assess the effects on cancer patient symptom distress of an eHealth system that alerts clinicians to significant changes in the patient's symptoms, as reported by a family caregiver. METHODS: A pooled analysis from two randomized clinical trials (NCT00214162 and NCT00365963) compared outcomes at 12 months for two unblinded groups: a control group (Comprehensive Health Enhancement Support System [CHESS]-Only) that gave caregivers access to CHESS, an online support system, and an experimental group (CHESS+CR [Clinician Report]), which also had CHESS but with a CR that automatically alerted clinicians if symptoms exceeded a predetermined threshold of severity. Participants were dyads (n=235) of patients with advanced lung, breast, or prostate cancer and their respective family caregivers from 5 oncology clinics in the United States of America. The proportion of improved patient threshold symptoms was compared between groups using area-under-the-curve analysis and binomial proportion tests. The proportion of threshold symptoms out of all reported symptoms was also examined. RESULTS: When severe caregiver-reported symptoms were shared with clinicians, the symptoms were more likely to be subsequently reported as improved than when the symptoms were not shared with clinicians (P<.001). Fewer symptom reports were completed in the group of caregivers whose reports went to clinicians than in the CHESS-Only group (P<.001), perhaps because caregivers, knowing their reports might be sent to a doctor, feared they might be bothering the clinician. CONCLUSIONS: This study suggests that an eHealth system designed for caregivers that alerts clinicians to worrisome changes in patient health status may lead to reduced patient distress. TRIAL REGISTRATION: Clinicaltrials.gov NCT00214162; https://clinicaltrials.gov/ct2/show/NCT00214162 (Archived by WebCite at http://www.webcitation.org/6nmgdGfuD) and Clinicaltrials.gov NCT00365963; https://clinicaltrials.gov/ct2/show/NCT00365963 (Archived by WebCite at http://www.webcitation.org/6nmh0U8VP).

The Contribution of the International Pain Policy Fellowship in Improving Opioid Availability in Georgia.

In the Republic of Georgia, the incidence and prevalence of cancer are increasing, signifying a growing need for palliative care and pain relief, including with controlled opioid medicines. As a signatory to the Single Convention, the Georgian government has a responsibility to ensure the adequate availability of controlled medicines for medical purposes; however, the consumption of morphine is very low, suggesting a high occurrence of unrelieved pain. In Georgia, palliative care development began in the 2000s including the adoption of a policy document in 2005, the creation of the National Palliative Care Coordinator in 2006, and important changes in Georgian legislation in 2007 and 2008, which served to lay a foundation for improving opioid availability. In 2008, a neurologist from the Sarajishvili Institute of Neurology and Neurosurgery in Tbilisi, and member of the Georgia National Association for Palliative Care, was selected to be an International Pain Policy Fellow to focus on improving opioid availability. Working with colleagues, government officials, and international experts, the Fellow contributed to several improvements to opioid availability, such as 1) positive changes to opioid prescribing legislation, 2) clarification of legislative terminology regarding dependence syndrome, 3) initiating the importation of both sustained-release and immediate-release oral morphine, and 4) improvements in the availability of sustained-release morphine. Despite these varied achievements, morphine consumption remains low in Georgia relative to the estimated amounts needed. The Fellow is continuing to study and understand the barriers that are impeding physician's prescription of opioids and patient's acceptance of them.

Initial construct validity evidence of a virtual human application for competency assessment in breaking bad news to a cancer patient.

BACKGROUND: Despite interest in using virtual humans (VHs) for assessing health care communication, evidence of validity is limited. We evaluated the validity of a VH application, MPathic-VR, for assessing performance-based competence in breaking bad news (BBN) to a VH patient. METHODS: We used a two-group quasi-experimental design, with residents participating in a 3-hour seminar on BBN. Group A (n=15) completed the VH simulation before and after the seminar, and Group B (n=12) completed the VH simulation only after the BBN seminar to avoid the possibility that testing alone affected performance. Pre- and postseminar differences for Group A were analyzed with a paired t-test, and comparisons between Groups A and B were analyzed with an independent t-test. RESULTS: Compared to the preseminar result, Group A's postseminar scores improved significantly, indicating that the VH program was sensitive to differences in assessing performance-based competence in BBN. Postseminar scores of Group A and Group B were not significantly different, indicating that both groups performed similarly on the VH program. CONCLUSION: Improved pre-post scores demonstrate acquisition of skills in BBN to a VH patient. Pretest sensitization did not appear to influence posttest assessment. These results provide initial construct validity evidence that the VH program is effective for assessing BBN performance-based communication competence.

Managing Cancer Pain in Older Adults.

Managing cancer pain in older adults can be complex and challenging. Understanding the unique needs of older patients with cancer is important to safe and effective pain management. The goals of this review are to discuss the assessment of older adults with cancer-related pain, treatment of cancer pain, and adverse effects or potential risks from treatment that are unique to older patients. A detailed pain assessment and when possible utilizing the geriatric assessment are vital to developing a cancer pain management plan. The geriatric assessment can help clinicians uncover problems not routinely assessed in the standard oncologic evaluation. Opioid pain medications are safe and effective for older adults with cancer pain as long as these medications are closely monitored and titrated slowly. In addition to the well-known adverse effects of opioid medications, clinicians need to be aware of the unique risks in older adults, which could include delirium, polypharmacy, and falls.

Characterizing the Nature of Scan Results Discussions: Insights Into Why Patients Misunderstand Their Prognosis.

INTRODUCTION: Patients with incurable cancer have poor prognostic awareness. We present a detailed analysis of the dialogue between oncologists and patients in conversations with prognostic implications. METHODS: A total of 128 audio-recorded encounters from a large multisite trial were obtained, and 64 involved scan results. We used conversation analysis, a qualitative method for studying human interaction, to analyze typical patterns and conversational devices. RESULTS: Four components consistently occurred in sequential order: symptom-talk, scan-talk, treatment-talk, and logistic-talk. Six of the encounters (19%) were identified as good news, 15 (45%) as stable news, and 12 (36%) as bad news. The visit duration varied by the type of news: good, 15 minutes (07:00-29:00); stable, 17 minutes (07:00-41:00); and bad, 20 minutes (07:00-28:00). Conversational devices were common, appearing in half of recordings. Treatment-talk occupied 50% of bad-news encounters, 31% of good-news encounters, and 19% of stable-news encounters. Scan-talk occupied less than 10% of all conversations. There were only four instances of frank prognosis discussion. CONCLUSION: Oncologists and patients are complicit in constructing the typical encounter. Oncologists spend little time discussing scan results and the prognostic implications in favor of treatment-related talk. Conversational devices routinely help transition from scan-talk to detailed discussions about treatment options. We observed an opportunity to create prognosis-talk after scan-talk with a new conversational device, the question "Would you like to talk about what this means?" as the oncologist seeks permission to disclose prognostic information while ceding control to the patient.

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial.

OBJECTIVES: To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group's experiences and learning preferences. METHODS: A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR's intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. SECONDARY OUTCOMES: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. RESULTS: MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. CONCLUSIONS: MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. PRACTICE IMPLICATIONS: MPathic-VR's virtual human simulation offers an effective and engaging means of advanced communication training.

A Multifaceted Approach to Improve the Availability and Accessibility of Opioids for the Treatment of Cancer Pain in Serbia: Results From the International Pain Policy Fellowship (2006-2012) and Recommendations for Action.

Cancer is the second leading cause of death in Serbia, and at least 14,000-16,000 patients experience moderate-to-severe cancer pain every year. Cancer pain relief has been impeded by inadequate availability of opioid analgesics and barriers to their accessibility. In 2006, a Serbian oncologist was selected as an International Pain Policy Fellow. The fellow identified barriers to opioid availability in Serbia and implemented an action plan to address the unavailability of oral morphine, attitudinal and knowledge barriers about opioids, and barriers in the national opioid control policy, in collaboration with the government, local partners, and international experts, including those from the World Health Organization. Collaborative efforts resulted in availability of immediate-release oral morphine, registration of controlled-release hydromorphone, and reimbursement of oral methadone for cancer pain; numerous educational activities aimed at changing inadequate knowledge and negative attitudes toward opioids; recognition of opioids as essential medicines for palliative care in a new National Palliative Care Strategy; and recognition of the medical use of opioids as psychoactive-controlled substances for the relief of pain included in a new national law on psychoactive-controlled substances, and the development of recommendations for updating regulations on prescribing and dispensing opioids. An increase in opioid consumption at the institutional and national levels also was observed. This article outlines a multifaceted approach to improving access to strong opioids for cancer pain management and palliative care in a middle-income country and offers a potential road map to success.