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1.  Concepts and Definitions for “Actively Dying,” “End of Life,” “Terminally Ill,” “Terminal Care,” and “Transition of Care”: A Systematic Review 
Context
The terms “actively dying,” “end of life,” “terminally ill,” “terminal care,” and “transition of care” are commonly used but rarely and inconsistently defined.
Objectives
We conducted a systematic review to examine the concepts and definitions for these terms.
Methods
We searched MEDLINE, PsycINFO, Embase, and CINAHL for published peer-reviewed articles from 1948 to 2012 that conceptualized, defined, or examined these terms. Two researchers independently reviewed each citation for inclusion and then extracted the concepts/definitions when available. We also searched 10 dictionaries, four palliative care textbooks, and 13 organization Web sites, including the U.S. Federal Code.
Results
One of 16, three of 134, three of 44, two of 93, and four of 17 articles defined or conceptualized actively dying, end of life, terminally ill, terminal care, and transition of care, respectively. Actively dying was defined as “hours or days of survival.” We identified two key defining features for end of life, terminally ill, and terminal care: life-limiting disease with irreversible decline and expected survival in terms of months or less. Transition of care was discussed in relation to changes in 1) place of care (e.g., hospital to home), 2) level of professions providing the care (e.g., acute care to hospice), and 3) goals of care (e.g., curative to palliative). Definitions for these five terms were rarely found in dictionaries, textbooks, and organizational Web sites. However, when available, the definitions were generally consistent with the concepts discussed previously.
Conclusion
We identified unifying concepts for five commonly used terms in palliative care and developed a preliminary conceptual framework toward building standardized definitions.
doi:10.1016/j.jpainsymman.2013.02.021
PMCID: PMC3870193  PMID: 23796586
Actively dying; end of life; systematic review; terminal care; terminally ill; terminology; transition of care
2.  Validation of Edmonton Symptom Assessment System in Korean Cancer Patients 
Journal of pain and symptom management  2013;46(6):10.1016/j.jpainsymman.2013.01.012.
Context
The Edmonton Symptom Assessment System (ESAS) is a brief, widely adopted multidimensional questionnaire to evaluate patient-reported symptoms.
Objectives
To develop a Korean version of the ESAS (K-ESAS) and to perform a psychometric analysis in Korean patients with advanced cancer.
Methods
We tested the K-ESAS in two pilot studies with 15 patients each. We assessed internal consistency, test-retest reliability, and concurrent validity in 163 Korean patients, who completed the K-ESAS along with the Korean versions of the M. D. Anderson Symptom Inventory (K-MDASI) and the Hospital Anxiety and Depression Scale (K-HADS) twice. Thirty-eight patients completed the questionnaires again seven days later to assess responsiveness.
Results
K-ESAS scores had good internal consistency, with a Cronbach’s alpha coefficient of 0.88, indicating that no questions had undue influence on the score. Pearson correlation coefficients for K-ESAS symptom scores between baseline and after 2–4 hours ranged from 0.72 (95% confidence interval [CI] 0.64, 0.79) to 0.87 (95% CI 0.82, 0.90), indicating strong test-retest reliability. For concurrent validity, Pearson correlation coefficients between K-ESAS symptom scores and corresponding K-MDASI symptom scores ranged from 0.70 (95% CI 0.62, 0.77) to 0.83 (95% CI 0.77, 0.87), indicating good concurrent validity. For the K-HADS, concurrent validity was good for anxiety (r = 0.73, 95% CI 0.65, 0.79) but moderate for depression (r = 0.4, 95% CI 0.26, 0.52). For responsiveness, changes in K-ESAS scores after seven days were moderately correlated with changes in K-MDASI scores but weakly correlated with changes in K-HADS scores.
Conclusion
The K-ESAS is a valid and reliable tool for measuring multidimensional symptoms in Korean cancer patients.
doi:10.1016/j.jpainsymman.2013.01.012
PMCID: PMC3851583  PMID: 23628516
advanced cancer; Edmonton Symptom Assessment System; ESAS; Korea
3.  Botulinum Toxin Injection and Phenol Nerve Block for Reduction of End-of-Life Pain 
Journal of Palliative Medicine  2013;16(12):1637-1640.
Abstract
Background: Injectable antispasticity agents have been utilized for the reduction of pain. However, there are no reports of its use for end-of-life pain.
Patient Case: A 62-year-old female with a history of progressive left frontotemporal glioblastoma status post gross total resection, radiation, and chemotherapy presented to the physical medicine and rehabilitation (PM&R) clinic for management of spastic quadriplegia and pain. At the time of presentation to the PM&R clinic she was no longer eligible for further cancer treatment. The patient had been declining neurologically with cognitive changes, weakness, and increasing spasticity. The patient had an Edmonton Symptom Assessment Scale (ESAS) pain score of 8/10 at her visit, as reported by her husband. She exhibited mild to moderate spasticity during the exam. Cognitively, she was unable to follow commands and would fluctuate between being awake for a few minutes and sleeping during the exam. She was not on any oral muscle relaxants and none were started due to her state of hypoarousal. Nine days after the initial consultation she received 700 units of onabotulinum toxin into her bilateral upper limbs and left thigh and a phenol nerve block to her left tibial nerve. At a follow-up visit 28 days later in the palliative care clinic, the ESAS pain score was 0. The patient died 51 days post-injection.
Conclusion: The case report demonstrates the use of injectable antispasticity agents in the reduction of end-of-life pain in a glioblastoma patient.
doi:10.1089/jpm.2013.0182
PMCID: PMC3868262  PMID: 24236959
4.  Clinical Signs of Impending Death in Cancer Patients 
The Oncologist  2014;19(6):681-687.
The authors examined the frequency and onset of 10 bedside physical signs and their diagnostic performance for impending death. They identified highly specific physical signs associated with death within 3 days among cancer patients.
Background.
The physical signs of impending death have not been well characterized in cancer patients. A better understanding of these signs may improve the ability of clinicians to diagnose impending death. We examined the frequency and onset of 10 bedside physical signs and their diagnostic performance for impending death.
Methods.
We systematically documented 10 physical signs every 12 hours from admission to death or discharge in 357 consecutive patients with advanced cancer admitted to two acute palliative care units. We examined the frequency and median onset of each sign from death backward and calculated their likelihood ratios (LRs) associated with death within 3 days.
Results.
In total, 203 of 357 patients (52 of 151 in the U.S., 151 of 206 in Brazil) died. Decreased level of consciousness, Palliative Performance Scale ≤20%, and dysphagia of liquids appeared at high frequency and >3 days before death and had low specificity (<90%) and positive LR (<5) for impending death. In contrast, apnea periods, Cheyne-Stokes breathing, death rattle, peripheral cyanosis, pulselessness of radial artery, respiration with mandibular movement, and decreased urine output occurred mostly in the last 3 days of life and at lower frequency. Five of these signs had high specificity (>95%) and positive LRs for death within 3 days, including pulselessness of radial artery (positive LR: 15.6; 95% confidence interval [CI]: 13.7–17.4), respiration with mandibular movement (positive LR: 10; 95% CI: 9.1–10.9), decreased urine output (positive LR: 15.2; 95% CI: 13.4–17.1), Cheyne-Stokes breathing (positive LR: 12.4; 95% CI: 10.8–13.9), and death rattle (positive LR: 9; 95% CI: 8.1–9.8).
Conclusion.
We identified highly specific physical signs associated with death within 3 days among cancer patients.
doi:10.1634/theoncologist.2013-0457
PMCID: PMC4041673  PMID: 24760709
Death; Diagnosis; Neoplasms; Palliative care; Physical examination; Sensitivity; Signs; Specificity
5.  Treatment of Dexamethasone-Induced Hiccup in Chemotherapy Patients by Methylprednisolone Rotation 
The Oncologist  2013;18(11):1229-1234.
Dexamethasone-induced hiccup (DIH) is an underrecognized symptom in patients with cancer, and little information is available about its treatment. The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment and to confirm the male predominance among those with cancer who experienced DIH during chemotherapy. DIH during chemotherapy could be controlled without losing antiemetic potential by replacing dexamethasone with methylprednisolone.
Background.
Dexamethasone-induced hiccup (DIH) is an underrecognized symptom in patients with cancer, and little information is available about its treatment. The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment and to confirm the male predominance among those with cancer who experienced DIH during chemotherapy.
Methods.
Persons with cancer who experienced hiccups during chemotherapy treatment and who were receiving treatment with dexamethasone were presumed to have DIH. The following algorithmic practice was implemented for antiemetic corticosteroid use: rotation from dexamethasone to methylprednisolone in the next cycle and dexamethasone re-administration in the second cycle of chemotherapy after recognition of hiccups to confirm DIH. All other antiemetics except corticosteroid remained unchanged. Patients (n = 40) were recruited from eight cancer centers in Korea from September 2012 to April 2013. Data were collected retrospectively.
Results.
Hiccup intensity (numeric rating scale [NRS]: 5.38 vs. 0.53) and duration (68.44 minutes vs. 1.79 minutes) were significantly decreased after rotation to methylprednisolone, while intensity of emesis was not increased (NRS: 2.63 vs. 2.08). Median dose of dexamethasone and methylprednisolone were 10 mg and 50 mg, respectively. Thirty-four (85%) of 40 patients showed complete resolution of hiccups after methylprednisolone rotation in the next cycle. Of these 34 patients, 25 (73.5%) had recurrence of hiccups after dexamethasone re-administration. Compared with baseline values, hiccup intensity (NRS: 5.24 vs. 2.44) and duration (66.43 minutes vs. 22.00 minutes) were significantly attenuated after dexamethasone re-administration. Of the 40 eligible patients, 38 (95%) were male.
Conclusion.
DIH during chemotherapy could be controlled without losing antiemetic potential by replacing dexamethasone with methylprednisolone. We also identified a male predominance of DIH. Further prospective studies are warranted.
doi:10.1634/theoncologist.2013-0224
PMCID: PMC3825309  PMID: 24107973
Dexamethasone; Hiccup; Methylprednisolone; Corticosteroids
6.  Discussing Goals of Care for a Delirious Advanced Cancer Patient in the Hospice Setting 
Journal of Palliative Medicine  2013;16(10):1313-1316.
Abstract
In the United States, patient autonomy is generally considered the most important ethical principle; however, patients sometimes make decisions that are medically futile or in conflict with the principles of beneficence and nonmaleficence. Difficult issues are often compounded if the patient loses capacity and a surrogate must provide substituted judgments. Allowing autonomy free reign can sometimes be detrimental to patient care and contribute to family distress. Here, we describe the case of a terminally ill patient whose conflicting desires were to have “everything” done—including cardiopulmonary resuscitation—and to simultaneously avoid hospitalization and die peacefully at home.
doi:10.1089/jpm.2012.0366
PMCID: PMC3791044  PMID: 23634814
7.  High Flow Oxygen and Bilevel Positive Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer: A Phase II Randomized Trial 
Context
Dyspnea is one of the most distressing symptoms for cancer patients. The role of high flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) in the palliation of dyspnea has not been well characterized.
Objectives
To determine the feasibility of conducting a randomized trial of HFO and BiPAP in cancer patients, and to examine the changes in dyspnea, physiologic parameters and adverse effects with these modalities.
Methods
In this randomized study (ClinicalTrials.gov Identifier: NCT01518140), we assigned hospitalized patients with advanced cancer and persistent dyspnea to either HFO or BiPAP for two hours. We assessed dyspnea with a numeric rating scale (NRS) and modified Borg scale (MBS) before and after the intervention. We also documented vital signs, transcutaneous carbon dioxide and adverse effects.
Results
Thirty patients were enrolled (1:1 ratio) and 23 (77%) completed the assigned intervention. HFO was associated with improvements in both NRS (mean 1.9, 95% confidence interval [CI] 0.4, 3.4; P=0.02) and MBS (mean 2.1, 95% CI 0.6, 3.5; P=0.007). BiPAP also was associated with improvements in NRS (mean 3.2; 95% CI 1.3, 5.1; P=0.004) and MBS (mean 1.5, 95% CI −0.3, 3.2; P=0.13). There were no significant differences between HFO and BiPAP in dyspnea NRS (P=0.14) and MBS (P=0.47). Oxygen saturation improved with HFO (93% vs. 99%, P=0.003), and respiratory rate had a non-statistically significant decrease with both interventions (HFO -3; P=0.11; BiPAP -2, P=0.11 ). No significant adverse effects were observed.
Conclusion
HFO and BiPAP alleviated dyspnea, improved physiologic parameters and were safe. Our results justify larger randomized controlled trials to confirm these findings.
doi:10.1016/j.jpainsymman.2012.10.284
PMCID: PMC3795985  PMID: 23739633
dyspnea; positive-pressure respiration; neoplasms; oxygen; randomized controlled trial; high flow oxygen; bilevel positive airway pressure
8.  Heart rate variability as a measure of autonomic dysfunction in men with advanced cancer 
European journal of cancer care  2013;22(5):612-616.
Autonomic dysfunction is common in patients with cancer and may have considerable negative effects on quality of life and mortality. This study retrospectively compared heart rate variability measured by the standard deviation of normal-to-normal intervals (SDNN) to Ewing test score, a composite score from a battery of five defined autonomic tests, in detection of autonomic dysfunction in 47 men with advanced cancer. The Ewing test score has been validated for diagnosis of autonomic dysfunction but is time-consuming and requires considerable patient cooperation; we hypothesized that SDNN, a much simpler test, is a useful alternative. The patients were categorised into three groups according to Ewing score: ≤2 (mild or no autonomic dysfunction), 2.5–3 (moderate) and ≥3.5 (severe). The SDNN (mean ± SD) for the three groups were 57.1±26.9 ms 62.3±22.4 ms and 37.7±20.3 ms, respectively. A significant negative correlation was found between Ewing score and SDNN (r= −0.40, p=0.005). A SDNN of ≤40 ms had 63% sensitivity and 75% specificity in the diagnosis of severe autonomic dysfunction (i.e., Ewing score ≥3.5). The positive predictive value of SDNN ≤40 ms in predicting moderate/severe autonomic dysfunction was 89%.
doi:10.1111/ecc.12066
PMCID: PMC3745803  PMID: 23627642
autonomic dysfunction; palliative care; Ewing test; heart rate variability
9.  Predictors of response to palliative care intervention for chronic nausea in advanced cancer outpatients 
Purpose
Nausea is a frequent and distressing symptom in advanced cancer patients. The objective of this retrospective study was to determine predictors of response to palliative care consultation for chronic nausea in advanced cancer outpatients.
Methods
Eligible patients included were outpatient supportive care center seen consecutively for an initial consultation and who had one follow-up visit within 30 days of the initial consultation. We reviewed the medical records of 1273 consecutive patients, and 444 (35%) were found to meet the eligibility criteria. All patients were assessed using the Edmonton Symptom Assessment Scale (ESAS). Nausea response was defined as an improvement of at least 30% between the initial visit and the first follow-up. We used logistic regression models to assess the possible predictors of improvement in nausea.
Results
112/444 patients (25%) experienced moderate/severe chronic nausea (ESAS item score ≥4/10). Higher baseline nausea intensity was significantly related to constipation (r=0.158; p=0.046) and all the symptoms assessed by the ESAS (p<0.001). Sixty-eight of the 112 (61%) patients with moderate/severe nausea at baseline showed a significant improvement at the follow-up visit (p<0.001). The main predictors for nausea response were improvement of fatigue (p=0.005) and increased appetite (p=0.003).
Conclusions
Baseline nausea was associated with all the ESAS symptom and improvement of fatigue and lack of appetite predicted a lower frequency of nausea at follow-up. More research is necessary to better understand the association between nausea severity and other symptoms and to predict which interventions will yield the best outcomes depending on the mix and severity of symptoms.
doi:10.1007/s00520-013-1805-8
PMCID: PMC3895156  PMID: 23584132
palliative care; chronic nausea; symptom management
10.  Treating an Established Episode of Delirium in Palliative Care: Expert Opinion and Review of the Current Evidence Base With Recommendations for Future Development 
Context
Delirium is a highly prevalent complication in patients in palliative care settings, especially in the end-of-life context.
Objectives
To review the current evidence base for treating episodes of delirium in palliative care settings and propose a framework for future development.
Methods
We combined multidisciplinary input from delirium researchers and other purposely selected stakeholders at an international delirium study planning meeting. This was supplemented by a literature search of multiple databases and relevant reference lists to identify studies regarding therapeutic interventions for delirium.
Results
The context of delirium management in palliative care is highly variable. The standard management of a delirium episode includes the investigation of precipitating and aggravating factors followed by symptomatic treatment with drug therapy. However, the intensity of this management depends on illness trajectory and goals of care in addition to the local availability of both investigative modalities and therapeutic interventions. Pharmacologically, haloperidol remains the practice standard by consensus for symptomatic control. Dosing schedules are derived from expert opinion and various clinical practice guidelines as evidence-based data from palliative care settings are limited. The commonly used pharmacologic interventions for delirium in this population warrant evaluation in clinical trials to examine dosing and titration regimens, different routes of administration, and safety and efficacy compared with placebo.
Conclusion
Delirium treatment is multidimensional and includes the identification of precipitating and aggravating factors. For symptomatic management, haloperidol remains the practice standard. Further high-quality collaborative research investigating the appropriate treatment of this complex syndrome is needed.
doi:10.1016/j.jpainsymman.2013.07.018
PMCID: PMC4081457  PMID: 24480529
Delirium; palliative care; evidence-based medicine; therapeutics; decision making; hospices
11.  Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care 
Context
Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear.
Objectives
This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development.
Methods
We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting.
Results
There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care.
Conclusion
Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development.
doi:10.1016/j.jpainsymman.2013.09.023
PMCID: PMC4128754  PMID: 24766743
Delirium; palliative care; practice guidelines
12.  An Analytical Framework for Delirium Research in Palliative Care Settings: Integrated Epidemiologic, Clinician-Researcher, and Knowledge User Perspectives 
Context
Delirium often presents difficult management challenges in the context of goals of care in palliative care settings.
Objectives
The aim was to formulate an analytical framework for further research on delirium in palliative care settings, prioritize the associated research questions, discuss the inherent methodological challenges associated with relevant studies, and outline the next steps in a program of delirium research.
Methods
We combined multidisciplinary input from delirium researchers and knowledge users at an international delirium study planning meeting, relevant literature searches, focused input of epidemiologic expertise, and a meeting participant and coauthor survey to formulate a conceptual research framework and prioritize research questions.
Results
Our proposed framework incorporates three main groups of research questions: the first was predominantly epidemiologic, such as delirium occurrence rates, risk factor evaluation, screening, and diagnosis; the second covers pragmatic management questions; and the third relates to the development of predictive models for delirium outcomes. Based on aggregated survey responses to each research question or domain, the combined modal ratings of “very” or “extremely” important confirmed their priority.
Conclusion
Using an analytical framework to represent the full clinical care pathway of delirium in palliative care settings, we identified multiple knowledge gaps in relation to the occurrence rates, assessment, management, and outcome prediction of delirium in this population. The knowledge synthesis generated from adequately powered, multicenter studies to answer the framework’s research questions will inform decision making and policy development regarding delirium detection and management and thus help to achieve better outcomes for patients in palliative care settings.
doi:10.1016/j.jpainsymman.2013.12.245
PMCID: PMC4128755  PMID: 24726762
Delirium; palliative care; risk factors; decision making; hospice; research framework; assessment; treatment; predictive model
13.  Experience of Barriers to Pain Management in Patients Receiving Outpatient Palliative Care 
Journal of Palliative Medicine  2013;16(8):908-914.
Abstract
Background
Patient-reported barriers are an important obstacle to cancer pain management. For effective pain management, exploring patient-reported barriers and related factors is important.
Objectives
The study's objective is to determine factors associated with patient-reported barriers to cancer pain management.
Method
We conducted a secondary analysis of data from a prospective observational study examining opioid adherence in palliative care outpatients. We evaluated the association between high score on patient-reported barriers to cancer pain management, on the Barriers Questionnaire II (BQ-II), and patients' race, sex, smoking history, pain intensity, opioid dose, and depression.
Results
Of 196 patients evaluated (median age 55 years), 147 (75%) were white, 41 (21%) had gastrointestinal cancer, and 121 (62%) were receiving anticancer treatment when data were collected. The median pain score was 4 (interquartile range [IQR] 3–7); 98% were receiving strong opioids; and 63% were satisfied with their pain medication. The median Edmonton symptom assessment scale (ESAS) depression score was 1 (IQR 0–3). Mean (SD) BQ-II scores were 1.8 (0.9) for physiologic effects, 1.6 (0.9) for fatalism, 0.9 (0.9) for communication, 2.3 (1.1) for harmful effects, and 1.7 (0.8) in total. Only racial differences were associated with high total BQ-II score in multivariable analysis (R2=0.05, overall F test significance=0.02). Pain related factors including opioids dose, pain intensity, and satisfaction were not associated with high BQ-II score.
Conclusion
Patients receiving palliative care expressed low barriers to pain control. There were minimal associations of BQ-II score with demographics and clinical factors.
doi:10.1089/jpm.2012.0610
PMCID: PMC3717202  PMID: 23758527
14.  Targeted Agent Use in Cancer Patients at the End of Life 
Context
The use of targeted therapy at the end-of-life has not been well characterized.
Objectives
To determine the frequency and predictors of targeted therapy use in the last days of life.
Methods
All adult patients residing in the Houston area who died of advanced cancer between September 1, 2009 and February 28, 2010 and had contact with our institution within the last three months of life were included. We collected baseline demographics and data on chemotherapy and targeted agents.
Results
Eight hundred sixteen patients were included: average age 62 years (range 21–97), female 48% and White 61%. The median interval between the last treatment and death was 47 (interquartile range [IQR] 21–97) days for targeted agents and 57 (IQR 26–118) days for chemotherapeutic agents. Within the last 30 days of life, 116 (14%) patients received targeted agents and 147 (18%) received chemotherapy. Regimens given in the last 30 days of life included a median of one (IQR 1–2) chemotherapeutic/targeted agents, and 43 (5%) patients receiving targeted agents had concurrent chemotherapy. The most common targeted agents in the last 30 days of life were erlotinib (n=25), bevacizumab (n=20), rituximab (n=11), gemtuzumab (n=8) and temsirolimus (n=8). On multivariate analysis, younger age (odds ratio [OR] 0.98 per year, P=0.01), hematologic malignancy (OR=6.1, P < 0.001) and lung malignancy (OR=2.6, P=0.05) were associated with increased targeted agent use in the last 30 days of life.
Conclusion
Targeted agents were used as often as chemotherapy at the end of life, particularly among younger patients and those with hematologic malignancies. Guidelines on targeted therapy use at the end of life are needed.
doi:10.1016/j.jpainsymman.2012.07.007
PMCID: PMC3594546  PMID: 23211648
Anti-neoplastic agents; end of life; palliative care; quality of care; supportive care; targeted agents
15.  Methylphenidate and/or a Nursing Telephone Intervention for Fatigue in Patients With Advanced Cancer: A Randomized, Placebo-Controlled, Phase II Trial 
Journal of Clinical Oncology  2013;31(19):2421-2427.
Purpose
Cancer-related-fatigue (CRF) is common in advanced cancer. The primary objective of the study was to compare the effects of methylphenidate (MP) with those of placebo (PL) on CRF as measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) fatigue subscale. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) was also assessed.
Patients and Methods
Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) were randomly assigned to one of the following four groups: MP+NTI, PL+NTI, MP + control telephone intervention (CTI), and PL+CTI. Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day. The primary end point was the median difference in FACIT-F fatigue at day 15. Secondary outcomes included anxiety, depression, and sleep.
Results
One hundred forty-one patients were evaluable. Median FACIT-F fatigue scores improved from baseline to day 15 in all groups: MP+NTI (median score, 4.5; P = .005), PL+NTI (median score, 8.0; P < .001), MP+CTI (median score, 7.0; P = .004), and PL+CTI (median score, 5.0; P = .03). However, there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups (5.5 v 6.0, respectively; P = .69) and among all four groups (P = .16). Fatigue (P < .001), nausea (P = .01), depression (P = .02), anxiety (P = .01), drowsiness (P < .001), appetite (P = .009), sleep (P < .001), and feeling of well-being (P < .001), as measured by the ESAS, significantly improved in patients who received NTI. Grade ≥ 3 adverse events did not differ between MP and PL (40 of 93 patients v 29 of 97 patients, respectively; P = .06).
Conclusion
MP and NTI alone or combined were not superior to placebo in improving CRF.
doi:10.1200/JCO.2012.45.3696
PMCID: PMC3691358  PMID: 23690414
16.  Family caregiver preferences for patient decisional control among Hispanics in the United States and Latin America 
Palliative medicine  2013;27(7):692-698.
Background
Understanding family caregivers’ decisional role preferences is important for communication, quality of care, and patient and family satisfaction. The family caregiver has an important role in a patient’s decisional role preferences. There are limited studies on family caregivers’ preferences of the patient’s decisional control at the end of life among Hispanics.
Aims
To identify Hispanic caregivers’ preferences of the decision control of patients with advanced cancer and to compare the preferences of caregivers in Latin America (HLA) and Hispanic American (HUSA) caregivers.
Design
We surveyed patients and their family caregivers referred to outpatient palliative care clinics in the United States, Chile, Argentina, and Guatemala. Caregiver preferences of patient’s decisional control were evaluated using the Control Preference Scale. Caregivers’ and patients’ socio-demographic variables, patient performance status, and HUSA patient acculturation level was also collected.
Participants
A total of 387 caregivers were surveyed: 100 (26%) in Chile, 99 (26%) in Argentina, 97 (25%) in Guatemala, and 91 (24%) in the United States. The median age was 56 years, and 59% were female.
Results
Caregiver preference of patients decisions control was passive, shared, and active by 10 (11%), 45 (52%) and 32 (37%) HUSA caregivers and 54 (19%), 178 (62%) and 55 (19%) HLA caregivers (p=0.0023). Caregiver acculturation level did not affect the preferences of the HUSA sample (p=0.60).
Conclusions
Most Hispanic family caregivers preferred the patient to make shared decisions. HLA caregivers preferred more frequently patients to assume a passive decisional role. Acculturation did not influence the preferences of HUSA caregivers.
doi:10.1177/0269216313486953
PMCID: PMC3742314  PMID: 23670718
Decisional role preferences; family caregivers; palliative care; Hispanics; Latinos
17.  Extreme hypothyroidism associated with sunitinib treatment for metastatic renal cancer 
Summary
Although thyroid abnormalities are reported with the use of tyrosine kinase inhibitors (TKI), patients rarely require replacement therapy. The initial multicenter studies of sunitinib for metastatic renal cancer did not report hypothyroidism in fatigued patients, and thyroid tests were not routinely monitored. More recent studies however, suggest up to 70% of patients develop thyroid test abnormalities during treatment with sunitinib. Despite these concerns, the clinical relevance of sunitinib-induced hypothyroidism is uncertain since thyroid gland recovery is the norm in most patients .We report a case of a patient with metastatic papillary renal cell cancer on combination anti-angiogenic therapy with sunitinib, who developed unusually high Thyroid Stimulating Hormone levels and severe symptoms despite receiving L-thyroxine. Our case also illustrates the complexity of managing sunitinib associated thyroid dysfunction, which may be accompanied by transient thyroiditis, hyperthyroidism and profound hypothyroidism.
doi:10.1179/1973947812Y.0000000022
PMCID: PMC4058856  PMID: 23040687
sunitinib; extreme hypothyroidism; symptoms
18.  “Whatever My Mother Wants”: Barriers to Adequate Pain Management 
Journal of Palliative Medicine  2013;16(6):709-712.
Abstract
Opioids are the preferred medications to treat cancer pain; however, several barriers to cancer pain management exist, including those related to the patient, health care provider, and family caregiver. We describe one such situation in which a family member prevents the patient from receiving adequate pain management at the end of life despite interdepartmental and interdisciplinary efforts. This case highlights the importance of understanding and addressing fears regarding opioid use and implementing an integrated approach including oncologists and palliative care physicians, along with early referrals to palliative care.
doi:10.1089/jpm.2012.0189
PMCID: PMC3667420  PMID: 22946542
19.  Patient-Physician Communication About Code Status Preferences: A Randomized Controlled Trial 
Cancer  2013;119(11):10.1002/cncr.27981.
Purpose
Code status discussions are important in cancer care. The best modality for such discussions has not been established. Our objective was to determine the impact of a physician ending a code status discussion with a question (autonomy approach) versus a recommendation (beneficence approach) on patients' do-not-resuscitate (DNR) preference.
Methods
Patients in a supportive care clinic watched two videos showing a physician-patient discussion regarding code status. Both videos were identical except for the ending: one ended with the physician asking for the patient's code status preference and the other with the physician recommending DNR. Patients were randomly assigned to watch the videos in different sequences. The main outcome was the proportion of patients choosing DNR for the video patient.
Results
78 patients completed the study. 74% chose DNR after the question video, 73% after the recommendation video. Median physician compassion score was very high and not different for both videos. 30/30 patients who had chosen DNR for themselves and 30/48 patients who had not chosen DNR for themselves chose DNR for the video patient (100% v/s 62%). Age (OR=1.1/year) and white ethnicity (OR=9.43) predicted DNR choice for the video patient.
Conclusion
Ending DNR discussions with a question or a recommendation did not impact DNR choice or perception of physician compassion. Therefore, both approaches are clinically appropriate. All patients who chose DNR for themselves and most patients who did not choose DNR for themselves chose DNR for the video patient. Age and race predicted DNR choice.
doi:10.1002/cncr.27981
PMCID: PMC3881425  PMID: 23564395
Code status; advanced cancer; communication; patient preferences
20.  Predictors of Long-Term Opioid Treatment Among Patients Who Receive Chemoradiation for Head and Neck Cancer 
The Oncologist  2013;18(6):768-774.
This retrospective study aimed to determined the proportion of patients with advanced head and neck cancer who continued to use opioids after the completion of radiation therapy. CAGE positivity was found to be a risk factor for opioid use beyond 3 months after the completion of radiation therapy and for duration of opioid treatment, indicating that routine screening and meticulous follow-up are needed for these patients.
Introduction.
The factors associated with successful opioid discontinuation after cancer treatment are not well-known. We determined the proportion of patients with advanced head and neck cancer who continued using opioids 3 months after the completion of radiation therapy with or without chemotherapy.
Methods.
We included 70 patients with head and neck cancer referred to our institution's supportive care center between January 1, 2008, and December 31, 2010. Patients who no longer used opioids 3 months after the completion of radiation therapy were classified as stoppers; patients who continued using opioids were considered nonstoppers. We compared demographics, cancer-related characteristics, alcoholism, substance abuse history, use of psychoactive drugs, and opioid-related factors between stoppers and nonstoppers.
Results.
In all, 44 of 70 patients (63%) and 23 of 70 patients (33%) continued opioids 3 months and 6 months after the completion of radiation therapy, respectively. A total of 18 of 44 nonstoppers (41%) and 3 of 26 stoppers (12%) were positive for alcoholism based on the CAGE questionnaire (i.e., Cut down, Annoying, Guilty, Eye opener; odds ratio: 5.3). Demographic and clinical characteristics did not differ between stoppers and nonstoppers. The median duration of any type of opioid use of CAGE-positive patients was significantly longer than that of CAGE-negative patients (median: 261 days vs. 93 days; hazard ratio: 2.5).
Conclusion.
CAGE positivity is a risk factor for opioid use beyond 3 months after the completion of radiation therapy and for duration of opioid treatment. Routine CAGE screening and meticulous follow-up are needed for these patients.
doi:10.1634/theoncologist.2013-0001
PMCID: PMC4063405  PMID: 23723332
Head and neck cancer; Opioids; CAGE; Treatment-related side effects; Radiation
21.  Use of Injectable Spasticity Management Agents in a Cancer Center 
Purpose
To analyze the utilization and effectiveness of injectable spasticity medications by the physiatry team at a tertiary referral based cancer center.
Methods
A retrospective review and analysis of patient and injection characteristics were obtained from patients who had received onabotulinum toxin or phenol nerve block injections from December 1, 2007 through January 31, 2012. Out of 3724 physiatry consultations during this period, 20 (less than 1%) different cancer patients received a total of 54 total procedures.
Results
The majority of patients (17/20, 85%) had a positive response to the injection. A positive response to an injection was defined by: 1) if the patient qualified to receive and was given another injection or 2) if there is a record of improvement if they did not receive another injection. 10/20 (50%) patients received only one injection. Of these, 7/10, (70%) reported a positive response to the injected agent. Those with only one injection, tended to live farther away and die sooner. 4/54 (7%) injection procedures resulted in undesirable reported side effects (2 phenol, 2 botulinum toxin). 9/54 (17%) procedures occurred while the patient was on a chemotherapy protocol. All patients were injected at least 1 year out from initial diagnosis.
doi:10.1007/s00520-012-1651-0
PMCID: PMC3586383  PMID: 23142955
22.  Relationships Among Body Mass Index, Longitudinal Body Composition Alterations, and Survival in Patients With Locally Advanced Pancreatic Cancer Receiving Chemoradiation. A Pilot Study 
Context
In pancreatic cancer, the presence of obesity or weight loss is associated with higher mortality.
Objectives
To explore the relationships among body mass index (BMI), longitudinal body composition alterations, and clinical outcomes in pancreatic cancer patients.
Methods
Records of 41 patients with inoperable, locally advanced pancreatic cancer who participated in a prospective chemo-radiation study were reviewed. Body composition was analyzed from two sets of computed-tomography images obtained before and after radiation treatment (median interval 104 days).
Results
Median age was 59 years, and 56% of patients female. Twenty-four (59%) patients were either overweight (22%) or obese (37%). Sarcopenia was present in 26 (63%) patients. At follow-up, weight loss was experienced by 33 (81%) patients. The median losses (%) before and after treatment were: weight 5% (P< 0.001), skeletal muscle (SKM) 4% (P=0.003), visceral adipose tissue (VAT) 13% (P< 0.001), and subcutaneous adipose tissue (SCAT) 11% (P=0.002). SKM loss positively correlated with age (P=0.03), baseline BMI (P < 0.001), and VAT (P=0.04) index. Obese patients experienced higher losses in weight (P=0.009), SKM (P=0.02), and VAT (P=0.02). Median survival was 12 months. In univariate analysis, age, baseline obesity, sarcopenic obesity, and losses (%) in weight, SKM, and VAT were associated with worse survival. In multivariate analysis, only age (hazard ratio (HR)=1.033, P=0.04 and higher VAT loss (HR=2.6, P=0.03) remained significant.
Conclusion
Our preliminary findings suggest that obese patients experience higher losses in weight, SKM and VAT, which may contribute to poorer survival in these patients.
doi:10.1016/j.jpainsymman.2011.09.010
PMCID: PMC3990439  PMID: 22695045
Cancer cachexia; pancreatic cancer; obesity and pancreatic cancer; body composition alterations; cancer
23.  Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial 
Journal of Clinical Oncology  2013;31(10):1271-1276.
Purpose
Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia.
Patients and Methods
We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056).
Results
After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28.
Conclusion
In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.
doi:10.1200/JCO.2012.43.6766
PMCID: PMC3607670  PMID: 23439759
24.  Predictors of high score patient-reported barriers to controlling cancer pain: a preliminary report 
Purpose
Pain is one of the most common and devastating symptoms in cancer patients, and misunderstandings on the patient’s part can cause major obstacles in pain management.
Method
We evaluated factors associated with patient’s high barrier score to managing cancer-associated pain by having 201 patients complete the Korean Barriers Questionnaire II, the Brief Pain Inventory—Korean, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and the Korean Beck Depression Inventory. The Pain Management Index (PMI) was also assessed.
Results
The patients were from nine oncology clinics in university hospitals and a veterans’ hospital in South Korea. The median pain score (0–10 scale) was 4, with a median percentage of pain improvement during the last 24 h of 70 %. A total of 150 patients (75 %) received strong opioids, and 177 (88 %) achieved adequate analgesia (positive PMI). Mean scores ± SD for the Barriers Questionnaire II ranged from 1.5 ± 1 to 2.8 ± 1.1, with the harmful effects subscale the highest. In the multiple regression model, depression was significantly associated with total barrier score to pain management (p < 0.0001). Pain reduction was significantly associated with the fatalism subscale.
Conclusions
Depression was associated with high barrier score in patients with cancer pain. Management of cancer pain should include screening for depression, and management of depression could reduce patient-reported barriers to pain management.
doi:10.1007/s00520-012-1646-x
PMCID: PMC3881357  PMID: 23151648
Cancer; Depression; Pain management
25.  Attrition rates, reasons and predictive factors in supportive and palliative oncology clinical trials 
Cancer  2012;119(5):1098-1105.
Background
Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons and predictors for dropout. We aimed to determine the rate, reasons and factors associated with attrition both before reaching the primary endpoint and the end of study.
Methods
We conducted a review of all prospective interventional supportive/palliative oncology trials in the Department of Palliative Care and Rehabilitation Medicine at MD Anderson Cancer Center between 1999–2011. Patient and study characteristics and attrition data were extracted.
Results
1214 patients were included in 18 clinical trials. The median age was 60, 41% had performance status ≥3, median fatigue 7/10 and median dyspnea 2/10. The attrition rate was 26% (95% confidence interval [CI] 23%-28%) for the primary endpoint and 44% (95% CI 41%-47%) for the end of study. Common reasons for primary endpoint dropout were symptom burden (21%), patient preference (15%), hospitalization (10%) and death (6%). Primary endpoint attrition was associated with higher baseline intensity of fatigue (odds ratio [OR]=1.10 per point, P=0.01) and longer study duration (P=0.04). End of study attrition was associated with higher baseline levels of dyspnea (OR=1.06, P=0.01), fatigue (OR=1.08, P=0.01), Hispanic race (OR=1.87, P=0.002), higher education (P=0.02), longer study duration (P=0.01) and outpatient studies (P=0.05).
Conclusions
The attrition rate was high in supportive/palliative oncology clinical trials, and was associated with various patient characteristics and high baseline symptom burden. These findings have implications for future clinical trial design including eligibility criteria and sample size calculation.
doi:10.1002/cncr.27854
PMCID: PMC3568443  PMID: 23132290
Attrition; Clinical trial; Neoplasms; Palliative Care; Supportive Care; Predictors; Research Design; Symptoms

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