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Timothy C Guetterman,1 Frederick W Kron,1 Toby C Campbell,2 Mark W Scerbo,3 Amy B Zelenski,4 James F Cleary,5 Michael D Fetters1 1Department of Family Medicine, University of Michigan, Ann Arbor, MI, 2Department of Medicine, University of Wisconsin–Madison, Madison, WI, 3Department of Psychology, Old Dominion University, Norfolk, VA, 4Department of General Internal Medicine, University of Wisconsin–Madison, University of Wisconsin Medical Foundation, 5Department of Medicine, School of Medicine and Public Health, University of Wisconsin–Madison, Clinical Science Center, Madison, WI, USA 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. Keywords: verbal behavior, health communication, informatics, clinical competence, empathy

Numerous studies have investigated the effect of Interactive Cancer Communication Systems (ICCSs) on system users' improvements in psychosocial status. Research in this area, however, has focused mostly on cancer patients, rather than on caregivers, and on the direct effects of ICCSs on improved outcomes, rather than on the psychological mechanisms of ICCS effects. To understand the underlying mechanisms, this study examines the mediating role of perceived caregiver bonding in the relation between one ICCS (the Comprehensive Health Enhancement Support System [CHESS]) use and caregivers' coping strategies. To test the hypotheses, a secondary analysis of data was conducted on 246 caregivers of lung cancer patients. These caregivers were randomly assigned to (a) the Internet, with links to high-quality lung cancer websites, or (b) access to CHESS, which integrated information, communication, and interactive coaching tools. Findings suggest that perceived bonding has positive effects on caregivers' appraisal and problem-focused coping strategies, and it mediates the effect of ICCS on the coping strategies 6 months after the intervention has begun. [ABSTRACT FROM AUTHOR]

Objectives: Familial caregivers are providing increasing amounts of care to advanced cancer patients. Increased understanding of caregivers' needs is vital in providing necessary support to lessen caregiver burden and morbidity. Current literature has identified caregiver and patient needs at broad stages of the cancer trajectory; however, such broad stages may be too general to inform a practice of targeting specific interventions when they have the greatest utility. This study examines a variety of particular needs across a number of more discrete illness-related transition experiences specifically in the advanced cancer disease trajectory.Methods: One hundred fifty-nine female informal caregivers of people with advanced cancer completed a needs assessment survey.Results: Analyses of these cross-sectional retrospective-report data reveal that cancer caregiver needs vary across specific key experiences occurring within the broader stages of illness identified by current literature. Furthermore, caregivers have unique needs during bereavement.Significance Of Results: Although the sample characteristics are demographically limited, this study provides preliminary evidence that the broad stages are not specific enough increments for effectively examining caregiver needs and supports the need for more precise distribution of cancer-related information at more discrete times in the illness course. [ABSTRACT FROM AUTHOR]

BACKGROUND: Management of neuropathic pain is challenging. Medications that interfere with sodium channel transport, such as lidocaine, mexilitene and flecainide, are promising as analgesics. OBJECTIVE: In a general population of patients with a working diagnosis of neuropathic pain, whether if flecainide produces enough of an improvement in pain to warrant further clinical study is determined. DESIGN: Phase I/II prospective exploratory clinical trial. Eligible patients were observed for week 1, then 50 mg flecainide was administered twice daily for week 2 and then administered 100 mg twice daily for week 3. Setting/ Subjects: Multi-institutional members of the Eastern Co-operative Oncology Group. Patients had neuropathic pain diagnosed by their oncologists as defined by the International Association for the Study of Pain and a diagnosis of cancer or AIDS. MEASUREMENTS: The Wisconsin Brief Pain Inventory was used. The primary endpoint was a decrease of 3 points (0-10 numerical scale) or a decrease of 50% in the worst pain rating at either day 15 or day 22 relative to the average of days 1 and 8 ratings. RESULTS: Nineteen patients were registered for the study. Four patients were ineligible. Of the remaining 15, one was unevaluable due to incomplete pain rating. Four out of 14 patients had an average drop of 5 points or 53% in their worst pain ratings on a 0-10 numerical scale of pain. No patients withdrew from study because of toxicity. There were no life-threatening or lethal toxicities. All patients were alive at the time of the analysis. CONCLUSIONS: Flecainide produced a 30% response rate. Response in this study was defined to be highly relevant and clinically significant reduction in pain. The drug merits study in a randomized placebo-controlled trial. Palliative Medicine 2007; 21: 667-672. [ABSTRACT FROM AUTHOR]

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.

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., (© 2021 the International Society of Dermatology.)

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., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

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; F 1,414 =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., (©Timothy C C Guetterman, Rae Sakakibara, Srikar Baireddy, Frederick W Kron, Mark W Scerbo, James F Cleary, Michael D Fetters. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.11.2019.)

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.

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., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

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-cm 2 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.

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)., (©David H Gustafson, Lori L DuBenske, Amy K Atwood, Ming-Yuan Chih, Roberta A Johnson, Fiona McTavish, Andrew Quanbeck, Roger L Brown, James F Cleary, Dhavan Shah. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.11.2017.)

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., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

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.

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., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Unplanned cancer-related hospital admissions often herald entry into the final phase of life. Hospitalized patients with advanced cancer have a high symptom burden and a short life expectancy, which may warrant palliative care intervention., Objectives: To identify the impact of implementing triggered palliative care consultation (TPCC) as part of standard care for patients admitted to the solid-tumor oncology service with advanced cancer., Methods: We conducted a prospective, sequential, three-cohort study to evaluate TPCC feasibility and impact using patient-reported outcomes, electronic medical records to identify resource utilization, and surveys of oncologists' perspectives on TPCC., Results: Sixty-five patients were evaluated before TPCC implementation (Cohort 1). Seventy patients (Cohort 2) were evaluated after initiation of TPCC, and 68 patients (Cohort 3) were evaluated after modifications based on implementation barriers identified in Cohort 2. The percentage of patients correctly identifying their cancer as incurable increased from 65% in Cohort 1 to 94% in Cohorts 2 and 3. TPCC had minimal impact on hospice utilization, cost of care, survival, patient-reported symptoms, and patient satisfaction, likely because of the limited nature of the intervention. Implementation was challenging, with only 60% of patients in Cohort 2 and 62% in Cohort 3 receiving TPCC. Overall, the intervention was viewed favorably by 74% of oncologists., Conclusion: Although TPCC was viewed favorably, implementation was logistically challenging because of short stays, high-acuity symptoms, and individual provider resistance. TPCC improved patients' understanding of their cancer. This population demonstrates high palliative care needs, warranting further research into how best to deliver care., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

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 $3.37 per day and $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.

Supportive care and palliative care are now recognised as critical components of global cancer control programmes. Many aspects of supportive and palliative care services are already available in some low-income and middle-income countries. Full integration of supportive and palliative care into breast cancer programmes requires a systematic, resource-stratified approach. The Breast Health Global Initiative convened three expert panels to develop resource allocation recommendations for supportive and palliative care programmes in low-income and middle-income countries. Each panel focused on a specific phase of breast cancer care: during treatment, after treatment with curative intent (survivorship), and after diagnosis with metastatic disease. The panel consensus statements were published in October, 2013. This Executive Summary combines the three panels' recommendations into a single comprehensive document covering breast cancer care from diagnosis through curative treatment into survivorship, and metastatic disease and end-of-life care. The recommendations cover physical symptom management, pain management, monitoring and documentation, psychosocial and spiritual aspects of care, health professional education, and patient, family, and caregiver education., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Globally, cancer incidence and mortality are increasing, and most of the burden is shifting to low- and middle-income countries (LMICs), where patients often present with late-stage disease and severe pain. Unfortunately, LMICs also face a disproportionate lack of access to pain-relieving medicines such as morphine, despite the medical and scientific literature that shows morphine to be effective to treat moderate and severe cancer pain. In 2008, an oncologist from Nepal, one of the poorest countries in the world, was selected to participate in the International Pain Policy Fellowship, a program to assist LMICs, to improve patient access to pain medicines. Following the World Health Organization public health model for development of pain relief and palliative care, the Fellow, working with colleagues and mentors, has achieved initial successes: three forms of oral morphine (syrup, immediate-release tablets, and sustained-release tablets) are now manufactured in the country; health-care practitioners are receiving training in the use of opioids for pain relief; and a new national palliative care association has developed a palliative care training curriculum. However, long-term implementation efforts, funding, and technical assistance by governments, philanthropic organizations, and international partners are necessary to ensure that pain relief and palliative care become accessible by all in need in Nepal and other LMICs., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Informal caregivers (family and friends) of people with cancer are often unprepared for their caregiving role, leading to increased burden or distress. Comprehensive Health Enhancement Support System (CHESS) is a Web-based lung cancer information, communication, and coaching system for caregivers. This randomized trial reports the impact on caregiver burden, disruptiveness, and mood of providing caregivers access to CHESS versus the Internet with a list of recommended lung cancer websites., Methods: A total of 285 informal caregivers of patients with advanced nonsmall cell lung cancer were randomly assigned to a comparison group that received Internet or a treatment group that received Internet and CHESS. Caregivers were provided a computer and Internet service if needed. Written surveys were completed at pretest and during the intervention period bimonthly for up to 24 months. Analyses of covariance (ANCOVAs) compared the intervention's effect on caregivers' disruptiveness and burden (CQOLI-C), and negative mood (combined Anxiety, Depression, and Anger scales of the POMS) at 6 months, controlling for blocking variables (site, caregiver's race, and relationship to patient) and the given outcome at pretest., Results: Caregivers randomized to CHESS reported lower burden, t(84) = 2.36, p = .021, d = .39, and negative mood, t(86) = 2.82, p = .006, d = .44, than those in the Internet group. The effect on disruptiveness was not significant., Conclusions: Although caring for someone with a terminal illness will always exact a toll on caregivers, eHealth interventions like CHESS may improve caregivers' understanding and coping skills and, as a result, ease their burden and mood.

Despite expert recognition that strong opioid analgesics are the cornerstone of treatment for moderate to severe pain, most of the world's population lacks adequate availability of opioids. Moreover, great disparities in availability of opioids continue to exist between higher- and lower-to-middle-income countries. This study examined more than 30 years of consumption data reported to the International Narcotics Control Board, from 1980 to 2011, for five opioids that are indicated for the treatment of moderate to severe pain: fentanyl, hydromorphone, morphine, oxycodone, and pethidine. As such, this study offers a regional and global perspective on opioid consumption, providing an indication of preparedness for treating moderate to severe pain. Countries are categorized according to the World Health Organization's six geographical regions. Morphine equivalence (ME) statistics were calculated for each study drug, allowing for equianalgesic comparisons between consumption of the study opioids and well as the ability to aggregate all study opioids (Total ME). The ME statistic is adjusted for country population, which allows for uniform global-, regional-, and country-level equianalgesic comparisons of consumption of morphine with other opioids. Although overall trend lines revealed general increases by region, profound inequities in opioid consumption continue to abound globally.

Purpose: To understand changes in pain severity over time and to explore the factors associated with pain changes in ambulatory patients with solid tumors., Patients and Methods: We enrolled 3,106 patients with invasive cancer of the breast, prostate, colon/rectum, or lung from multiple sites. At baseline and 4 to 5 weeks later, patients rated their pain level on a 0 to 10 numerical rating scale. A 2-point change in pain score was defined as a clinically significant change in pain. Multivariable logistic models were fitted to examine the effects of pain management and demographic and clinical factors on change in pain severity., Results: We analyzed 2,761 patients for changes in pain severity. At initial assessment, 53.0% had no pain, 23.5% had mild pain, 10.3% had moderate pain, and 13.2% had severe pain. Overall, one third of patients with initial pain had pain reduction within 1 month of follow-up, and one fifth had an increase, and the improvement and worsening of pain varied by baseline pain score. Of the patients without pain at initial assessment, 28.4% had pain (8.9% moderate to severe) at the follow-up assessment. Logistic regression analysis showed that inadequate pain management was significantly associated with pain deterioration, as were lower baseline pain level, younger age, and poor health status., Conclusion: One third of patients have pain improvement and one fifth experience pain deterioration within 1 month after initial assessment. Inadequate pain management, baseline pain severity, and certain patient demographic and disease characteristics are associated with pain deterioration.

Challenges exist in assimilating palliative care within community-based services for nursing home eligible low-income elders with complex chronic illness as they approach the end of life (EOL). This study assessed the feasibility of a consultation model, with hospice clinicians working with three Care Wisconsin Partnership Program teams. Consults occurred primarily during team meetings and also informally and on joint patient visits and were primarily with the palliative care nurse addressing physical issues. Fifty-seven percent of consultant recommendations were implemented. Benefits of consultation were identified with focus groups of clinical staff as were opportunities and barriers to the implementation. Models of integration are proposed.

This commentary relates to the recently published essay in PLOS Medicine, entitled "Untreated Pain, Narcotics Regulation, and Global Health Ideologies." That essay describes regulatory and other systemic barriers preventing the accessibility of opioid analgesics and contributing to patients not receiving adequate pain relief. Four main points highlighted in the essay are discussed in this commentary: (1) the role of international treaties in medication availability; (2) the role of the International Narcotics Control Board in medication availability; (3) the role of regulatory policy in treating pain; and (4) the role of opioid analgesics in treating pain. Recent authoritative statements and activities suggest a strengthened infrastructure within which governments currently can work to improve the availability of controlled medicines to enhance patient pain and palliative care services.

Background: Using available communication technologies, clinicians may offer timely support to family caregivers in managing symptoms in patients with advanced cancer at home., Aim: To assess the effects of an online symptom reporting system on caregiver preparedness, physical burden, and negative mood., Design: A pooled analysis of two randomized trials (NCT00214162 and NCT00365963) was conducted to compare caregiver outcomes at 6 and 12 months after intervention between two randomized, unblinded groups using General Linear Mixed Modeling. Caregivers in one group (Comprehensive Health Enhancement Support System-Only) were given access to an interactive cancer communication system, the Comprehensive Health Enhancement Support System. Those in the other group (Comprehensive Health Enhancement Support System + Clinician Report) received access to Comprehensive Health Enhancement Support System plus an online symptom reporting system called the Clinician Report. Clinicians of patients in the Comprehensive Health Enhancement Support System + Clinician Report group received e-mail alerts notifying them when a symptom distress was reported over a predetermined threshold., Setting/participants: Dyads (n = 235) of advanced-stage lung, breast, and prostate cancer patients and their adult caregivers were recruited at five outpatient oncology clinics in the United States., Results: Caregivers in the Comprehensive Health Enhancement Support System + Clinician Report group reported less negative mood than those in the Comprehensive Health Enhancement Support System-Only group at both 6 months (p = 0.009) and 12 months (p = 0.004). Groups were not significantly different on caregiver preparedness or physical burden at either time point., Conclusions: This study provides new evidence that by using an online symptom reporting system, caregivers may experience less emotional distress due to the Clinician Report's timely communication of caregiving needs in symptom management to clinicians.

Background: In this study, the authors examined the effectiveness of an online support system (Comprehensive Health Enhancement Support System [CHESS]) versus the Internet in relieving physical symptom distress in patients with non-small cell lung cancer (NSCLC)., Methods: In total, 285 informal caregiver-patient dyads were assigned randomly to receive, for up to 25 months, standard care plus training on and access to either use of the Internet and a list of Internet sites about lung cancer (the Internet arm) or CHESS (the CHESS arm). Caregivers agreed to use CHESS or the Internet and to complete bimonthly surveys; for patients, these tasks were optional. The primary endpoint-patient symptom distress-was measured by caregiver reports using a modified Edmonton Symptom Assessment Scale., Results: Caregivers in the CHESS arm consistently reported lower patient physical symptom distress than caregivers in the Internet arm. Significant differences were observed at 4 months (P = .031; Cohen d = .42) and at 6 months (P = .004; d = .61). Similar but marginally significant effects were observed at 2 months (P = .051; d = .39) and at 8 months (P = .061; d = .43). Exploratory analyses indicated that survival curves did not differ significantly between the arms (log-rank P = .172), although a survival difference in an exploratory subgroup analysis suggested an avenue for further study., Conclusions: The current results indicated that an online support system may reduce patient symptom distress. The effect on survival bears further investigation., (Copyright © 2013 American Cancer Society.)

Context: Morphine has been considered the gold standard for treating moderate-to-severe pain, although many new opioid products and formulations have been marketed in the last two decades and should be considered when examining opioid consumption. Understanding opioid consumption is improved by using an equianalgesic measure that controls for the strengths of all examined opioids., Objectives: The research objective was to use a morphine equivalence (ME) metric to determine the extent that morphine consumption relates to the total consumption of all other study opioids., Methods: An ME metric was created for morphine and the aggregate consumption of each study opioid (Total ME), adjusted for country population to allow for uniform equianalgesic comparisons. Graphical and statistical evaluations of morphine use and Total ME consumption trends (between 1980 and 2009) were made for the global and geographic regional levels and selected developed and developing countries., Results: Global morphine consumption rose dramatically in the early 1980s but has been significantly outpaced by Total ME since 1996. As expected, the extent of morphine and Total ME consumption varied notably among regions, with the Americas, Europe, and Oceania regions accounting for the highest morphine use and Total ME in 2009. Developing and least developed countries, compared with developed countries, demonstrated lower overall Total ME consumption., Conclusion: Generally, worldwide morphine use has not increased at the rate of Total ME, especially in recent years. Examining a country's ability to effectively manage moderate-to-severe pain should extend beyond morphine to account for all available potent opioids., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Despite improvements in cancer therapies, cancer is the leading cause of death worldwide. Many patients experience severe, unnecessary symptoms during treatment as well as at the end of life. Often, patients receive 'aggressive' care at the end of life that is discordant with their preferences. Palliative care is an approach that focuses on communication and quality of life, including treatment of physical, psychosocial, and spiritual suffering. This approach is appropriate for patients with life-limiting cancer, throughout the course of their disease. A growing body of evidence supports the integration of palliative care into routine cancer care, owing to the benefits in symptom control, quality of life, patient satisfaction, and resource utilization. Palliative care can be delivered in inpatient, outpatient, and home-based settings. The specialty and associated infrastructure is expanding rapidly with support from the international medical community. The ideal model of how to incorporate palliative care providers into the care of patients with cancer is yet to be defined; future research is needed to develop delivery systems and improve access to palliative care services. Through collaboration between oncologists and palliative care teams, there is hope of improving the quality of care for patients with both curable and life-limiting cancers.

Background: Many international governmental and nongovernmental organizations regard unrelieved cancer pain as a significant global public health problem. Although opioids such as morphine are considered essential medicines in the provision of palliative care and for treating cancer pain, especially when the pain is severe, low- and middle-income countries often lack such medications., Aim: The primary aim of this study was to examine countries' government and health-care system influences on opioid availability for cancer pain and palliative care, as a means to identify implications for improving appropriate access to prescription opioids., Design: A multivariate regression of 177 countries' consumption of opioids (in milligrams/death from cancer and AIDS) contained country-level predictor variables related to public health, including Human Development Index, palliative care infrastructure, and health system resources and expenditures., Results: Results were highly explanatory (adjusted R(2) = 82%) and Human Development Index was the most predictive variable when controlling for all other factors in the statistical model (B = 11.875, confidence interval = 10.216, 13.534, p < 0.0001)., Conclusions: Study findings demonstrate that a limited number of predictor variables characterizing a country's government and health-care system infrastructure can explain its opioid consumption level, with the greatest influence being very high Human Development Index. However, Human Development Index is not the most policy-relevant factor, and this finding should be reconciled against the reality that many countries with low or medium Human Development Index have succeeded in creating and sustaining a health-care system to strengthen cancer pain care and palliative care, including through the appropriate use of essential prescription opioids.

Introduction: Despite advances in the care of patients with cancer over the last 10 years, cancer remains the second leading cause of death in the United States. Many patients receive aggressive, in-hospital end-of-life care at high cost. There are few data on outcomes after unplanned hospitalization of patients with metastatic cancer., Methods: In 2000 and 2010, data were collected on admissions, interventions, and survival for patients admitted to an academic inpatient medical oncology service., Results: The 2000 survey included 191 admissions of 151 unique patients. The 2010 survey assessed 149 admissions of 119 patients. Lung, GI, and breast cancers were the most common cancer diagnoses. In the 2010 assessment, pain was the most common chief complaint, accounting for 28%. Although symptoms were the dominant reason for admission in 2010, procedures and imaging were common in both surveys. The median survival of patients after discharge was 4.7 months in 2000 and 3.4 months in 2010. Despite poor survival in this patient population, hospice was recommended in only 23% and 24% of patients in 2000 and 2010, respectively. Seventy percent of patients were discharged home without additional services., Conclusion: On the basis of our data, an unscheduled hospitalization for a patient with advanced cancer strongly predicts a median survival of fewer than 6 months. We believe that hospital admission represents an opportunity to commence and/or consolidate appropriate palliative care services and end-of-life care.

In 2011, the World Health Organization (WHO) published a series of 21 guidelines to assist governments in improving their national drug control laws, regulations, and administrative procedures to promote the availability of controlled medicines for pain relief and for a variety of acute and chronic diseases and conditions. These guidelines ultimately are designed to encourage the development of policies designed to fulfill a country's dual obligation concerning these medicines: to prevent their abuse, diversion and trafficking while ensuring access for medical and scientific purposes. This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them. It is hoped that representatives of governments and medical institutions, as well as health care professionals, will commonly and effectively use the revised WHO guidelines as a policy change tool.

Objective: Caregivers maintain critical roles in cancer patient care. Understanding cancer-related information effects both caregiver involvement and ability to have needs met. This study examines the mediating role caregiver's clinic visit involvement has on the relationships between caregiver's information competence and their need fulfillment and clinic visit satisfaction., Methods: Secondary analysis of 112 advanced lung, breast, and prostate cancer caregivers participating in a large clinical trial. Caregiver information competence was assessed at pretest. Involvement, need fulfillment, and visit satisfaction were assessed immediately following the clinic appointment., Results: Involvement correlated with information competence (r=.21, p<.05), need fulfillment (r=.48, p<.001), and satisfaction (r=.35, p<.001). The correlation between information competence and need fulfillment (r=.26, p<.01) decreased when controlling for involvement (r=.19, p=.049), demonstrating mediation, and accounted for 24.4% of the variance in need fulfillment. The correlation between information competence and satisfaction (r=.21, p=.04), decreased and was non-significant when controlling for involvement (r=.15, p=.11), demonstrating mediation, and accounted for 13% of variance in visit satisfaction., Conclusion: Caregiver's clinic visit involvement mediates the relationships between their information competence and their need fulfillment and visit satisfaction., Practice Implications: Efforts to improve the caregiving experience, and potentially patient outcomes, should focus on system-wide approaches to facilitating caregivers' involvement and assertiveness in clinical encounters., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Over the cancer disease trajectory, from diagnosis and treatment to remission or end of life, patients and their families face difficult decisions. The provision of information and support when most relevant can optimize cancer decision making and coping. An interactive health communication system (IHCS) offers the potential to bridge the communication gaps that occur among patients, family, and clinicians and to empower each to actively engage in cancer care and shared decision making. This is a report of the authors' experience (with a discussion of relevant literature) in developing and testing a Web-based IHCS-the Comprehensive Health Enhancement Support System (CHESS)-for patients with advanced lung cancer and their family caregivers. CHESS provides information, communication, and coaching resources as well as a symptom tracking system that reports health status to the clinical team. Development of an IHCS includes a needs assessment of the target audience and applied theory informed by continued stakeholder involvement in early testing. Critical issues of IHCS implementation include 1) need for interventions that accommodate a variety of format preferences and technology comfort ranges; 2) IHCS user training, 3) clinician investment in IHCS promotion, and 4) IHCS integration with existing medical systems. In creating such comprehensive systems, development strategies need to be grounded in population needs with appropriate use of technology that serves the target users, including the patient/family, clinical team, and health care organization. Implementation strategies should address timing, personnel, and environmental factors to facilitate continued use and benefit from IHCS.

Previous research has indicated that treatment staff often underestimate the informational needs of cancer patients. In this study, the authors determined the total number of information sources obtained and used to influence treatment decisions, and the clinical and demographic factors associated with the use of specific sources of information in cancer patients. Participants were identified by the statewide cancer registry and diagnosed in 2004 with breast, colorectal, lung, or prostate cancer. A self-administered mailed questionnaire elicited cancer treatments, demographics, and information sources used to make treatment decisions. Of those surveyed, 1,784 (66%) participated and responded to all questions regarding information use. Over 69% of study participants reported obtaining information from a source other than the treatment staff. Significant predictors of using additional information sources included younger age, higher income, higher education, complementary and alternative medicine (CAM) use, and reporting shared decision making (all p values <.01). Participants with a college degree were more likely to use the Internet (OR 3.7; 95% CI 1.5-9.0) and scientific research reports (OR 3.3; 95% CI 1.6-6.9) to influence treatment decisions compared with those without a high school degree. Support group use to influence treatment decisions was not associated with socioeconomic variables but did vary by cancer type and CAM use. The sources of information study participants obtained and used to influence treatment decisions varied strongly by socioeconomic and demographic variables. These findings provide a deeper understanding of the information needs of cancer patients and have implications for dissemination strategies that can minimize disparities in access to cancer information.

Background: We retrospectively examined the treatment efficacy and toxicity profile of intensity-modulated radiotherapy (IMRT) plus concurrent weekly cisplatin chemotherapy in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC)., Methods: A total of 57 patients with stage III or IV HNSCC were treated with IMRT and concurrent weekly cisplatin (dosed at 30 mg/m(2)) between November 2001 and May 2007. The median prescription dose to the gross tumor volume was 70 Gy (using 2.0-2.2 Gy daily fractions)., Results: In-field tumor control at 2 years was 89.1%, locoregional control was 85.5%, and overall survival was 86.9%. The median radiation dose delivered was 70 Gy. The mean dose intensity of cisplatin administered was 25.7 mg/m(2)/week., Conclusion: Comprehensive head and neck IMRT to 70 Gy delivered with weekly cisplatin chemotherapy (30 mg/m(2)) is feasible and generally well tolerated.

Objective: Opioid analgesics are the drugs of choice for the treatment of moderate to severe acute and cancer pain. Although their role in the management of chronic pain not related to cancer is controversial, there is increasing evidence for their benefit in certain patient populations., Design: A 32-item survey to assess Wisconsin physicians' knowledge, beliefs, and attitudes toward opioid analgesic use was mailed to 600 randomly selected licensed physicians, resulting in a 36% response rate., Results: Half of the respondents considered diversion a moderate or severe problem in Wisconsin. A majority considered addiction to be a combination of physiological and behavioral characteristics, rather than defining it solely as a behavioral syndrome. Most physicians felt it lawful and acceptable medical practice to prescribe opioids for chronic cancer pain, but only half held this view if the pain was not related to cancer. Fewer physicians considered such prescribing as lawful and generally accepted medical practice if the patient had a history of substance abuse. About two-thirds of physicians were not concerned about being investigated for their opioid prescribing practices, but some admitted that fear of investigation led them to lower the dose prescribed, limit the number of refills, or prescribe a Schedule III or IV rather than a Schedule II opioid., Conclusion: Wisconsin physicians who responded to this survey held many misconceptions about the prescribing of opioids. Such views, coupled with a lack of knowledge about laws and regulations governing the prescribing of controlled substances, may result in inadequate prescribing of opioids with resultant inadequate management of pain.

Background: There are no clear predictors clinicians can use to determine who is more likely to experience dose-limiting toxicity (DLT) in phase I chemotherapy clinical trials. Many providers are reluctant to refer older adults to phase I trials because of concerns about the development of toxicity. The goal of this study was to identify clinical and nonclinical factors which were associated with the development of DLT in phase I studies., Methods: Patients (pts) were included if they were treated at maximally tolerated dose (MTD) and above. Studies were included only if MTD was reached. Data collected included age, comorbidity (Cumulative Illness Rating Score-Geriatrics), labs at enrollment, height, weight, performance status, cancer type, duration of diagnosis, prior treatment, drug level, smoking status, marital status, mean income, percent of population high school educated as determined by ZIP code, and distance to the phase I trial hospital. Those who did and did not have DLT were compared by bivariate and then multivariate analysis., Results: A total of 242 charts were reviewed from 24 cytotoxic chemotherapy studies, and 27 different types of cancer were represented. On bivariate analysis, mean age, household income (higher), weight, body surface area, dose of drug, alkaline phosphatase, hemoglobin, and LDH were significantly associated with DLT (P < 0.05). CIRS-G score was not associated with DLT. In multivariate analysis, dose level (P = 0.004) and distance from the phase I trial hospital (P = 0.04) were still significant predictors of DLT. Age did not predict for severity of DLT., Conclusions: Age and comorbidity did not predict for development of DLT in phase I chemotherapy trials. Many of these pts were very fit, with relatively low CIRS-G scores, so the impact of comorbidity may not have been fully evaluated. Several social and clinical factors may predict for development of DLT. A prospective study is being planned to confirm these results.